Assessment of the Capability of PulmoVista 500 to Continuously Monitor Changes of Ventilation Over Time
Conditions: Mechanical Ventilation, Single-lung Ventilation, ARDS, ALI - Acute Lung Injury, Weaning From Ventilator
Sponsor: Drägerwerk AG & Co. KGaA

 
 
CLINICAL INVESTIGATION PLAN 
(according to DIN EN ISO 14155:2012-01) 
ASSESSMENT OF THE CAPABILITY OF PULMOVISTA 
500 TO CONTINUOUSLY MONITOR CHANGES OF 
VENTILATION OVER TIME.  
„PulmoVista 500“ 
Multicenter, prospective, non-interventional, open trial 
 
Version 1.0F, 21.11.2016 
Autors: Associate Professor (USA) Dr. med. Oliver C. Radke 
Felix Fischer, Mario Graf 
Sponsor: 
Drägerwerk AG & Co. KGaA 
Moislinger Alle 53-55 
23558 Lübeck, Germany 
CIP Code: PV500 
 
Coordinating Investigator: 
PD Dr. med. Peter Spieth 
 
 
Confidentiality 
The information given in this study protocol is to be treated strictly 
confidential. It only serves to inform the investigators and other persons 
involved in the conduct of the study as well as the Ethic Committee and the 
Authorities. This study protocol may not be given to noninvolved persons 
without the allowance of the Principal Investigator and/or the Sponsor. 
 
 

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Investigator 
We, the undersigned, agree to conduct this study according to the above 
protocol. We commit our-selves to treat, to follow-up, and to document all 
included participants according to the study protocol. 
 
 
 
______________________________ 
________________________ 
Name 
Date, Signature 
 
 
 
______________________________ 
________________________ 
Name 
Date, Signature 
 
 
 
______________________________ 
________________________ 
Name 
Date, Signature 
 
 

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TABLE OF CONTENTS  
Table of Contents....................................................................................................................................................3 
Table of abbrevations ..........................................................................................................................................7 
1 
Introduction .................................................................................................................................8 
1.1 
Involved Persons/Institutions ................................................................................................. 8 
1.2 
Synopsis..................................................................................................................................................11 
2 
Investigational Device  PulmoVista 500 ............................................................ 16 
2.1 
Summary description and purpose...................................................................................16 
2.2 
Details concerning the manufacturer..............................................................................16 
2.3 
Manufacturing of PulmoVista 500 and supply to the trial sites.................16 
2.4 
Description of the Investigational Device ...................................................................16 
2.5 
Summary of the necessary training and experience needed 
to use PulmoVista 500 ................................................................................................................19 
3 
Justification for the Design of the Clinical Trial ........................................... 19 
4 
Risks and Benefits of the Investigational Device and Clinical 
Investigation ............................................................................................................................ 20 
4.1 
Anticipated Clinical Benefit and anticipated Adverse Device 
Effects .......................................................................................................................................................20 
4.2 
Residual Risks associated with the Investigational Device, as 
identified in the Risk Analysis Report .............................................................................20 
4.3 
Possible Mutual Reactions ........................................................................................................20 
4.4 
Procedure to reduce Risks .......................................................................................................21 
5 
Objectives and Hypotheses.......................................................................................... 21 
5.1 
Objectives..............................................................................................................................................21 
5.1.1 Primary Study Objectives .........................................................................................................21 
5.1.2 Secondary Study Objectives ..................................................................................................21 
6 
Design of the Clinical Investigation....................................................................... 21 
6.1 
General ....................................................................................................................................................21 
6.1.1 Type, Design, Principal Investigator................................................................................21 
6.1.2 Blinding....................................................................................................................................................22 
6.1.3 Primary and Secondary Study Endpoints ....................................................................22 
6.1.4 Investigation of Endpoints .......................................................................................................23 

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6.1.5 Study relevant Devices...............................................................................................................23 
6.1.6 Procedures to replace Participants....................................................................................23 
6.2 
Concomittant Medical Manouvers ......................................................................................23 
6.2.1 Exposition to Medical Device .................................................................................................24 
6.2.2 Use of Medical Device..................................................................................................................24 
6.3 
Participants...........................................................................................................................................24 
6.3.1 Inclusion criteria ..............................................................................................................................24 
6.3.2 Exclusion criteria .............................................................................................................................24 
6.3.3 Population and Indication.........................................................................................................25 
6.3.4 Duration and Timelines of the Clinical Investigation .........................................25 
6.3.5 Duration per Participant ............................................................................................................25 
6.3.6 Number of Participants ...............................................................................................................25 
6.3.7 Recruiting Timeline ........................................................................................................................25 
6.4 
Study Procedures ............................................................................................................................26 
6.4.1 Visit 1 - Screening and Informed Consent .................................................................26 
6.4.1.1 
Patients who are not yet admitted to ICU .......................................................26 
6.4.1.2 
Patients who are already in the ICU.....................................................................26 
6.4.2 Visit 2 - Medical and Study Measurement ..................................................................26 
6.4.2.1 
Patients currently on or scheduled for ventilator care in 
the ICU.....................................................................................................................................................26 
6.4.2.2 
Patients scheduled for elective surgery with OLV .....................................27 
6.4.4 Visit 3 - Follow-Up-Visit .............................................................................................................28 
6.5 
Responsabilitys of Sponsor and Investigator ...........................................................28 
6.6 
Monitoring .............................................................................................................................................29 
7 
Statistical Considersations............................................................................................ 29 
7.1 
Sample size, Drop-out-Rates, Level of Significance and 
Power of the Clinical Investigation ...................................................................................29 
7.2 
Statistical Design.............................................................................................................................30 
7.3 
Pass/Fail Criteria ..............................................................................................................................31 
7.4 
Interim Anaylsis ...............................................................................................................................31 
7.5 
Criteria for the termination of the clinical investigation on 
statistical grounds ..........................................................................................................................31 

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7.6 
Procedures for reporting any deviations from original 
statistical plan ....................................................................................................................................31 
7.7 
Specification of Subgroups ......................................................................................................32 
7.8 
Procedures that take into account all data ................................................................32 
7.9 
Treatment of missing, unused or spurious data, including 
drop outs and withdrawals ......................................................................................................32 
8 
Data und Datamanagment ........................................................................................... 32 
8.1 
Procedures used for data review, database cleaning, and 
issuing and resolving data queries ...................................................................................33 
8.2 
Subject Identification Number..............................................................................................34 
8.3 
Validation and securing electronic database systems.......................................34 
8.4 
Archiving of data and Duration............................................................................................34 
9 
Amendments ............................................................................................................................ 34 
10 
Adherence to the Protocol............................................................................................. 35 
11 
Device Accountability ........................................................................................................ 35 
12 
Statements of Compliance, Insurance................................................................ 36 
12.1 Statement of Compliance .........................................................................................................36 
12.2 Insurance ...............................................................................................................................................37 
13 
Informed Consent Process............................................................................................ 37 
14 
Adverse Events, Adverse Device Effects and Device Deficiencies38 
14.1 Definition Adverse Event (AE) ..............................................................................................38 
14.2 Documentation and Reporting of AE(s) ........................................................................38 
15 
Serious Adverse Events (SAE) .................................................................................. 39 
15.1 Documentation and Notification of SAE – Investigators 
Responsibility......................................................................................................................................39 
16 
Device Deficiency (DD) ................................................................................................... 39 
16.1 Definition Device Deficiency (DD) .....................................................................................39 
16.2 Definition and reporting of Incident.................................................................................40 
16.3 Device Complaints ..........................................................................................................................40 
16.4 List of foreseeable Adverse Events and anticipated Adverse 
Device Effects.....................................................................................................................................41 
16.5 Emergency contact points........................................................................................................41 
16.6 Emergency procedures ...............................................................................................................42 

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16.7 Follow up of Participants ...........................................................................................................42 
17 
Vulnerable Population under pressure ................................................................ 42 
18 
Premature Termination or Suspension of Clinical Investigation.... 42 
18.1 Criteria for  Premature Termination or Suspension of Clinical 
Investigation .......................................................................................................................................42 
18.1.1 
Individual ....................................................................................................................................42 
18.1.2 
Overall ...........................................................................................................................................43 
18.2 Procedures for Premature Termination or Suspension of a 
Single Site .............................................................................................................................................43 
18.3 Procedures for Premature Termination or Suspension.....................................43 
19 
Planned Termination of Clinical Investigation .............................................. 44 
20 
Data security and publication policy..................................................................... 44 
20.1 Patient identification and confidentiality ......................................................................44 
20.2 Declaration regarding Data Protection ..........................................................................44 
20.3 Declaration regarding the Pseudonymized Transfer of 
Personal Data .....................................................................................................................................45 
20.4 Publication Policy .............................................................................................................................45 
21 
Signatures .................................................................................................................................. 46 
22 
Bibliography.............................................................................................................................. 47 
23 
Attachments ............................................................................................................................. 48 
23.1 Clinical Usability Questionaire...............................................................................................48 
23.2 Clinical Plausability Questionaire........................................................................................49 
 

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TABLE OF ABBREVATIONS 
AE 
 
adverse event 
ADE  
adverse device effect 
ALI  
acute lung injury 
BfArM 
federal 
authority 
(dt.:Bundesinstitut 
für 
Arzneimittel und 
Medizinprodukte) 
CCF  
cross-correlation function 
CPAP  
Continuous Positive Airway Pressure 
CT 
 
computed tomography 
DLT  
double lumen tube 
(e)CRF 
 
(electronic) case report form 
EIT   
electrical impedance tomography 
FPFV  
first patient first visit 
GCP  
good clinical practice 
ICD  
implantable cardioverter defibrillator 
ICH  
International Counsil on Harmonization 
ICU  
Intensive Care unit 
IfU 
 
Instructions for Use 
ITT 
 
Intent To Treat 
ISF 
 
investigator site file 
KKS  
Coordination Centre for Clinical Trials 
LPLV  
last patient last visit 
MPG  
german medical device law 
MRI  
magnetic resonance imaging 
NA 
 
not applicable 
NaCl  
Sodium chloride 
ND 
 
not done 
OLV  
one lung ventilation 
PDA  
peridural anesthesia 
PEEP  
positive end-expiratory pressure 
SAE  
serious adverse event  
SADE  
serious adverse device effect 
SAS  
statistical analysis system 
SBT  
spontaneous breathing trial 
SDV  
source data verification 
SOP  
standard operating procedure 
SPSS  
statistical package for the social sciences 
TEA  
thoracic epidural anesthesia 
TMF  
trial master file 
USADE 
unanticipated serious adverse device effect 
VT 
tidal volume 

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1 
INTRODUCTION 
1.1 
INVOLVED PERSONS/INSTITUTIONS 
Sponsor and manufacturer of the product:  
Drägerwerk AG & Co. KGaA 
 
 
represented by, 
 
Dipl.-Ing. Felix Fischer 
 
Moislinger Allee 53-55,  23558 Lübeck, 
 
Germany 
 
Phone:  +49 451 882 2888 
 
Fax: +49 451 882 72888 
 
Coordinating Investigator: 
 
PD Dr. med. Peter Spieth 
Klinik und Poliklinik für Anästhesiologie  
und Intensivtherapie 
 
Universitätsklinikum Carl Gustav Carus 
 
der Technischen Universität Dresden 
 
Fetscherstraße 74, 01307 Dresden 
Germany 
 
Medical Advisor: 
Associate Professor (USA) Dr. med. Oliver C. Radke   
Klinik für Anästhesiologie und Operative 
Intensivmedizin 
 
Klinikum Bremerhaven-Reinkenheide gGmbH 
Postbrookstraße 103, 27574 Bremerhaven 
Germany 
 
Phone: +49 471 299 3268 
 
 
Fax: +49 471 299 3268  
 
E-Mail: oradke@pcat.de 
 
Trial site 1: 
Klinik 
und 
Poliklinik 
für 
Anästhesiologie 
und 
 
Intensivtherapie  
 
Medizinischen Fakultät Carl Gustav Carus 
 
der Technischen Universität Dresden 
 
Fetscherstraße 74, 01307 Dresden 
Germany 
 
 
 
 

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Trial site 2: 
Klinik für Anästhesiologie und Intensivmedizin 
 
Medizinische Hochschule Hannover (MHH)  
 
Carl-Neuberg-Str. 1,  
30625 Hannover 
 
Germany  
 
 
Trial Management/Monitoring:  
Mario Graf,  
Koordinierungszentrum für Klinische Studien 
Dresden 
 
der Medizinischen Fakultät Carl Gustav Carus 
 
der Technischen Universität Dresden 
 
Fetscherstraße 74, 01307 Dresden 
Germany 
 
Phone: +49 351 458-18622 
 
Fax: 
+49 351 458-5799 
 
E-Mail: mario.graf@uniklinikum-dresden.de 
 
Data Management: 
Stephan Friedrich, KKS Dresden 
 
Koordinierungszentrum für Klinische Studien 
 
Dresden 
 
der Medizinische Fakultät Carl Gustav Carus 
 
der Technischen Universität Dresden 
 
Fetscherstraße 74, 01307 Dresden 
Germany 
 
Phone: 0351 458-14963 
 
Fax: 
0351 458-5799 
 
E-Mail: stephan.friedrich@uniklinikum-dresden.de 
 
 
Biostatisticians: 
Statistical Planning: 
 
Prof. Dr. med. Michael Imhoff 
 
Abteilung für Medizinische Informatik, 
 
Biometrie und Epidemiologie 
 
Ruhr-Universität Bochum, 44780 Bochum   
 
Home Office:  
 
Buchenweg 18c-d, 23568 Lübeck 
Germany 
 
Phone: +49-451-707698-0  
 
Fax: +49-451-707698-29  
 
Mobile: +49-171-7411198  
 
Email: mike@imhoff.de 
 

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Statistical Evaluation: 
 
Uta Schwanebeck 
 
Koordinierungszentrum für Klinische Studien 
Dresden 
 
der Medizinischen Fakultät Carl Gustav Carus 
 
der Technischen Universität Dresden 
 
Fetscherstraße 74, 01307 Dresden 
Germany 
 
Phone: +49 351 458-15134 
 
Fax: 
+49 351 458-5799 
 
E-Mail: uta.schwanebeck@uniklinikum-dresden.de 
 
 
 
 

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1.2 
SYNOPSIS 
 
Title 
Assessment of the capability of PulmoVista 500 to 
continuously monitor changes of ventilation over 
time. 
Short Title 
PulmoVista 500 
Target population 
 
Following patients will be enrolled: 
- Intensive care unit (ICU) patients, who are 
mechanically ventilated via an artificial airway 
(endotracheal tube or tracheostomy cannula) 
and  who are expected to be subjected to major 
changes in their ventilator settings will be 
monitored with the PV500 device before, during 
and after the changes. These changes in the 
ventilator settings should result in recognizable 
changes in the distribution of ventilation in the 
lungs. 
Examples of such interventions are: 
 Spontaneous breathing trial (SBT) using the 
ventilator (as opposed to SBT using a T-
piece) 
 Switching 
between 
different 
modes 
of 
ventilation 
(e.g. 
volume 
controlled, 
pressure 
controlled, 
pressure support, 
CPAP) 
 Initial adjustment of ventilation after ICU 
admission  
 Weaning from ventilation in preparation for 
extubation 
 PEEP trials and recruitment maneuvers 
 Suctioning maneuvers 
- 
Patients who are scheduled for surgeries that 
require blocking of one bronchus (e.g. one-
lung-ventilation by insertion of a double lumen 
tube or bronchial blocker) 
 
Trial design 
Multicenter, prospective, non-interventional, open 
trial 
Objectives of the 
Trial 
Primary objective 
The capability of PulmoVista 500 to continuously 

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monitor venti
lation and its changes.  
Secondary Objective 
 To assess the capabi
l
ity of PulmoVista 500 to 
detect regional changes of venti
lation and lung 
volume. 
 Documentation of any safety events related to 
the use of PulmoVista 500 
 Assessing the use specific cl
inical helpfulness of 
PulmoVista 500 
Endpoints of the Trial 
 
Primary Endpoint 
The capabi
l
ity of PulmoVista 500 for continuous 
monitoring of venti
lation and its changes at 
different points in time during varying states of 
regional venti
lation, the cross-correlation function 
(CCF) between global tidal impedance (EIT) 
waveforms and global tidal volume (venti
lator) 
curves wi
l
l be evaluated. 
Secondary Endpoints  
- First secondary endpoint: 
To assess the capabi
l
ity of PulmoVista 500 to 
detect changes in regional venti
lation by 
evaluating the cross correlation between 
impedance waveforms derived from 
PulmoVista 
500 and volume curves derived from venti
lator 
during one-lung-venti
lation. 
- Assess that changes of tidal volumes 
induced 
by venti
lator settings can be monitored by the 
“Trends view” (see chapter 23.2) 
- Assess that changes of the end-expiratory lung 
volumes (induced by e.g. PEEP changes, 
recruitment and suctioning maneuvers) can be 
monitored by “dEELI trend view” (see chapter 
23.2) 
- Documentation of any safety events related to 
the use of PulmoVista 500 
- Cl
inical helpfulness of PulmoVista 500 is proven 
if 
 see attachments (chapter 23.1) cl
inical 
usabi
l
ity 
Sample Size 
 80 patients  
25 patients shal
l be enrol
led in a subgroup of 
patients with one-lung-venti
lation (OLV)  

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Anticipated Duration Relating to trial 
First patient first visit:  January 2017 
Last patient last visit: 
September 2017 
Relating to patient:  
8 hours  
   
 
 
(+Safety Fol
low-up) 
 
Inclusion Criteria 
 The population included in the cl
inical study wi
l
l 
be selected from a pool of patients undergoing 
respiratory support who are scheduled to have 
their venti
lation settings changed. 
As a subgroup, patients who are scheduled for 
surgeries that need one-lung-venti
lation (OLV) 
wi
l
l be enrol
led to the study. 
 Male and female patients at the age of 18 years 
or older 
 On respiratory support in ICU care or scheduled 
for such ( e.g. postoperatively) or scheduled for 
surgery with OLV 
 Patients of which the monitoring of venti
lation 
distribution may be of cl
inical interest 
 Patients being venti
lated via an artificial airway 
with a mechanical venti
lator that is compatible 
with PulmoVista 500   
 Patients scheduled for changes in venti
lation 
settings that may cause relevant changes in the 
venti
lation 
 Chest circumference between 70 and 150 cm 
 Written informed consent to participate in the 
study provided by either the patient or the legal 
representative of the patient.  
Exclusion Criteria 
 Currently has a permanent or temporary 
pacemaker, implantable cardiac device (ICD) or 
other device emitting electrical energy 
 a BMI ≥ 50 
 tidal volume (VT) ≤ 200 mL 
 Current uncontrol
led body movements such as 
tics, tremors or seizures,  
 Current wound dressings or infections on the 
chest that might interfere with the PulmoVista 
500 electrode belt placement  
 Women of chi
ld bearing potential whose 
pregnancy cannot be excluded based on a 
pregnancy test or other proven facts. 

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 
Allergic to materials used in the electrode belt 
 
Participation of the patient in an interventional 
trial 
within 
the 
last 
four 
weeks 
before 
enrollment in this trial 
 
Evidence suggesting that the patient or his legal 
representative is not likely to follow the trial 
protocol (e.g. lacking compliance) 
 
Known infectious diseases that require isolation 
of patient (e.g. MRSA) 
 
Concomitant use of an air anti-decubitus 
medical mattress with dynamic inflation that 
cannot 
be 
deactivated 
during 
EIT 
measurements 
Conduct of the trial 
Visit 1 - Screening and Enrollment  (Day (-2) - 0)) 
 Screening  
 Pregnancy Test or Exclusion 
 Check Inclusion and Exclusion Criteria 
 Informed Consent Process 
 Demography 
 Clinical Anamnesis 
 Medical History  
 
Visit 2  (Day 0)  
 EIT measure 
 Recording of EIT Data 
 
Visit 3 - Follow up (Day 1 - 3) 
 Check of adverse events 
General 
 Data 
of 
CT-, 
MRI-images, 
ultrasound 
assessments 
and 
radiographs 
not 
taken 
especially for this study, but due to necessary 
medical treatment taken during the period of 
day –2 to +3. 
 
Trial related pro-
cedures and labor-
atory examinations 
 Measurement 
with 
PulmoVista 
500 during 
ventilation for a maximum period of eight hours  
 Pregnancy test if necessary 
Investigational 
device 
 
PulmoVista 500 is a non-invasive monitoring 
device used as an adjunctive diagnostic tool 
for assessing the distribution of ventilation in 

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Manufacturer: 
 
patients undergoing respiratory support. 
Drägerwerk AG & Co. KGaA 
 
Moislinger Allee 53-55 
23558 Lübeck, Germany 
 
 
 
 
 
Table 1:  Visit Schedule 
scheduled for day 
Visit 1 
Screening and 
Enrollment 
Visit 2 
 
Trial 
 
Visit 3 
 
Follow Up 
(safety) 
(-2) or (-1) or 0 
0 
1 or 2 or 3 
Informed Consent 
X 
 
 
Inclusion/Exclusion 
Criteria 
X 
 
 
Demographics 
X 
 
 
Medical/Treatment 
History 
X 
 
 
Vital Signs 
X 
X 
 
Pregnancy Testing 
X 
 
 
SAE administration 
 
X 
X 
 
 
 

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2 
INVESTIGATIONAL DEVICE  
PULMOVISTA 500 
2.1 
SUMMARY DESCRIPTION AND PURPOSE  
PulmoVista 500 is a lung function monitor for clinical use which continuously 
generates cross-sectional images of the lung function by applying the 
technique of electrical impedance tomography (EIT).  
To perform bio-impedance measurements, an electrode belt containing 16 
electrodes is placed around the chest wall. Additionally, one reference 
electrode must be attached to a central point to the body, preferably on the 
abdomen. The reference electrode ensures that all measurements at different 
electrode pairs are referenced to the same electric potential1 . 
PulmoVista 500 provides graphical information about the regional distribution 
of ventilation and changes of end-expiratory lung volume. The temporal 
resolution of this information allows observing specific conditions of different 
lung regions. 
PulmoVista 500 is a CE released class IIa medical device manufactured by 
Drägerwerk AG & Co. KGaA, Lübeck Germany. It is distributed within Europe 
since April 2011. 
2.2 
DETAILS CONCERNING THE MANUFACTURER 
Drägerwerk AG & Co. KGaA is an international company in the fields of 
medical and safety technology. Since 1889, Dräger has been developing 
technical devices and solutions for use in clinical, industrial or mining 
applications, in firefighting or rescue services.  
2.3 
MANUFACTURING OF PULMOVISTA 500 AND SUPPLY TO THE 
TRIAL SITES  
The device PulmoVista 500 is produced by the Drägerwerk AG & Co. KGaA 
Dräger provides one of the devices to each trial site as a loan device for the 
duration of the study. 
2.4 
DESCRIPTION OF THE INVESTIGATIONAL DEVICE 
PulmoVista 500 is a non-invasive monitoring device used as an adjunctive 
diagnostic tool for assessing the distribution of ventilation. PulmoVista 500 
                                        
1 Teschner E, Imhoff M, Leonhardt S. Electrical Impedance Tomography: The realisation of 
regional ventilation monitoring. Drägerwerk AG & Co. KGaA 2015; Reference-Nbr 90 66 788; 
19 

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allows visualization and evaluation of the lungs by applying the Electrical 
Impedance Tomography (EIT) technique. 
PulmoVista 500 continuously determines the regional bioimpedance of the 
tissue within one cross-sectional plane (the so-called "electrode plane") of the 
thorax. To perform the EIT measurements, an electrode belt (F) containing 16 
electrodes has to be placed around the chest wall of the patient and must be 
connected to PulmoVista 500 via a patient cable and a trunk cable (G, H). The 
electrode belt is made of silicone rubber, whereas the electrodes are made of 
conductive, carbonized silicone rubber. The electrode cables are made of 
different plastics (thermoplastic polyurethane (TPU), polyamide (PA), 
polyurethane (PUR), polypropylene (PP), thermoplastic elastomer (TPE), 
polybutylene terephthalate (PBT)). The impedance of lung tissue varies with 
the air content. Thus, ventilation distribution and changes of end-expiratory 
lung volume that occur within the electrode plane can be detected and 
displayed. 
PulmoVista 500 is made up of the Infinity Medical Cockpit C500 (A), the 
Power Supply Unit P2500 (E) and the EIT module (C). Handle (B) and trolley 
(D) allow easy transport of PulmoVista 500 within the hospital. 
 
 
 
Infinity Medical Cockpit C500 (A) 
The Infinity Medical Cockpit provides the user interface of PulmoVista 500 in 
form of a standardized display and control unit that is also used in other 
Dräger products. The display software running on the Infinity Medical Cockpit 

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uses common standardized operating concepts applied for various Dräger 
products to facilitate ease of use for the clinicians. 
Power Supply Unit P2500 (E) 
The Power Supply Unit P2500 converts the AC mains supply voltage into a DC 
safety low voltage to power the EIT module as well as the Infinity Medical 
Cockpit. The Power Supply Unit is medical grade implementing all required 
safety measures for medical electrical equipment to protect patient, user and 
bystander. 
EIT Module (C) 
The EIT module is the signal processing front-end that generates the 
measurement currents and determines the resulting voltages at the chest 
electrodes. 
The software version of PulmoVista 500 is named as 1.12. Upgrades of this 
version will be possible and documented  
 
 
Applied Standards in full or in part: 
EN ISO 14971: 2009 
(ISO 14971: 2007) 
Medical Devices - Application of Risk 
Management to Medical Devices 
EN 60601-1: 2006 / AC: 2010 
(IEC 60601-1: 2005 / CORR 1: 2006 / 
CORR 2: 2007) 
(IEC 60601-1:1988/A1: 1991/ A2: 1995) 
Medical electrical equipment -- Part 1: 
General requirements for basic safety 
and essential performance 
EN 60601-1-2: 2007 / AC: 2010                
(IEC 60601-1-2: 2007) 
(IEC 60601-1-2:2001/A1:2004) 
Medical electrical equipment Part 1-2: 
General requirements for safety  – 
Collateral standard: Electromagnetic 
Compatibility - Requirements and tests 
EN 60601-1-6: 2007 
(IEC 60601-1-6: 2006) 
(IEC 60601-1-6: 2004) 
Medical electrical equipment Part 1-2: 
General requirements for safety  – 
Collateral standard: Usability 
EN ISO 10993-1: 2009 / AC : 2010 
(ISO 10993-1: 2009) 
Biological Evaluation of Medical Devices – 
Part 1: Evaluation and Testing within a 
Risk Management Process 
EN ISO 10993-5: 2009 
(ISO 10993-5: 2009) 
Biological Evaluation of Medical Devices – 
Part 5: Tests for in Vitro Cytotoxicity 
EN ISO 10993-10: 2009 
(ISO 10993-10: 2009) 
Biological Evaluation of Medical Devices – 
Part 10: Tests for Irritation and Delayed-
Type Hypersensitivity 
EN 980: 2008 
Graphical symbols for use in the labelling 
of medical devices 
EN 1041: 2008 
Information supplied by the manufacturer 
with medical devices 
 
 

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2.5 
Summary of the necessary training and experience needed to 
use PULMOVISTA 500 
During the initiation visit of each trial site a training has to be performed by a 
representative of Drägerwerk AG & Co. KGaA introducing the use of the 
device and standardized data acquisition for study purposes. 
3 
JUSTIFICATION FOR THE DESIGN OF THE 
CLINICAL TRIAL 
3.1 
BACKROUND 
Acute Lung Injury (ALI) is a very common complication within the population 
of intensive care patients2 3 4. It has been shown that mechanical ventilation 
with ventilator settings which do not suit the individual requirements of the 
diseased lung can lead to injury of the cellular structures of the lung tissue. 
As a result, vascular and alveolar permeability increases and interstitial 
edema formation occurs. Due to the increased weight of the lung, alveolar 
collapse may predominantly occur in the independent lung regions, resulting 
in even more severe hypoxemia5 6. 
3.2 
IMPACTS OF STUDY RESULTS 
The results of this study will help us to define the capability and reliability of 
PulmoVista 500 to detect changes in both global and regional ventilation. As 
this is a non-invasive, observational trial, we neither do expect a positive nor 
a negative impact on the actual study participants. The results will, however, 
                                        
2 Rubenfeld GD. Epidemiology of acute lung injury. Crit Care Med 2003; 31:S276-S284. 
3 Brun-Buisson C, Minelli C, Bertolini G, Brazzi L, Pimentel J, Lewandowski K, Bion J, Romand JA, 
Villar J, Thorsteinsson A, Damas P, Armaganidis A, Lemaire F; ALIVE Study Group. Epidemiology 
and outcome of acute lung injury in European intensive care units. Intensive Care Med 2004; 
30:4-6. 
4 Goss CH, Brower RG, Hudson LD, Rubenfeld GD; ARDS Network. Incidence of acute lung 
injury in the United States. Crit Care Med 2003;31:1607-11. 
5 Gattinoni L, Pesenti A, Bombino M, Baglioni S, Rivolta M, Rossi F, Rossi G, Fumagalli R, 
Marcolin M, Mascheroni D, Torresin A. Relationships between lung computed tomographic 
density, gas exchange, and PEEP in Acute Respiratory Failure. Anesthesiology 1988; 69: 824-
832 
6 Spiro SG, Silvestri GA, Agusti A (2012). Clinical Respiratory Medicine. (4th edition) Elsevier, 
ISBN-13- 9781455707928. 

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improve our knowledge about the EIT technology and thus aid the use of this 
technology for the benefit of future patients.  
Additionally, detailed analysis of the recorded data will be very valuable for 
future directions of both clinical research and clinical applications of the EIT 
technology. 
Furthermore this study will provide data needed for authorization in other 
countries e.g. Japan.  
4 
RISKS AND BENEFITS OF THE 
INVESTIGATIONAL DEVICE AND CLINICAL 
INVESTIGATION 
4.1 
ANTICIPATED CLINICAL BENEFIT AND ANTICIPATED ADVERSE 
DEVICE EFFECTS 
Anticipated clinical benefit: 
By participating in the clinical study, the patient benefits of a close monitoring 
as part of the study, which goes beyond the clinical routine.  
Anticipated adverse device effects: 
The use of the device according to the normal conditions of use, may cause 
skin irritation to the patient or pressure marks caused by the electrode belt. 
4.2 
RESIDUAL RISKS ASSOCIATED WITH THE INVESTIGATIONAL 
DEVICE, AS IDENTIFIED IN THE RISK ANALYSIS REPORT  
Residual Risk associated with the Investigation Device: 
PulmoVista 500 is a CE released class IIa medical device. According to the 
risk analysis for the conformity assessment according to the ISO 14971 there 
exists no unacceptable individual or overall residual risk for the medical 
device. 
Risks associated with participating in the clinical trial: 
Since the study is a non-interventional observational study without additional 
study-related changes in the treatment of patients, no additional study risks 
occur through the participation in this clinical study. 
4.3 
POSSIBLE MUTUAL REACTIONS  
The use of the device according to the normal conditions of use, may cause 
skin irritation to the patient or pressure marks caused by the electrode belt. 
(see above 4.1) 

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4.4 
PROCEDURE TO REDUCE RISKS 
As described in the instructions for use of the device the patient's skin should 
be checked periodically for any discomfort or injury. 
In case of intolerance reactions, signs of progressive infection, skin reactions 
or mechanical irritation, which go beyond the usual extent, the measurement 
is interrupted and an adequate therapy initiated. The patient will be requested 
to report problems immediately to the investigator. 
5 
OBJECTIVES AND HYPOTHESES 
5.1 
OBJECTIVES 
5.1.1 PRIMARY STUDY OBJECTIVES 
To assess the capability of PulmoVista 500 to continuously monitor ventilation 
and its changes. 
5.1.2 SECONDARY STUDY OBJECTIVES 
 
To assess the capability of PulmoVista 500 to detect regional changes 
of ventilation and lung volume. 
 
Documentation of any safety events related to the use of PulmoVista 
500 
 
Assessing the use specific clinical helpfulness of PulmoVista 500 
6 
DESIGN OF THE CLINICAL INVESTIGATION 
6.1 
GENERAL 
The clinical trial will be conducted according to the German Medical Device Act 
as § 23 b clinical trial. There is no need to access an approval by federal 
authority (BfArM).  
The trial can start only after obtaining a positive review by all local Ethics 
Committees. The written approval of the EC and written exemption of 
approval must be filed in the Sponsor File. Additionally, every participating 
site must receive a copy of these documents to be filed in the Investigator 
Site File (ISF).  
6.1.1 TYPE, DESIGN, PRINCIPAL INVESTIGATOR 
The trial is a multicenter observational study. This study will be conducted in 
compliance with ISO 14155. It is sponsored by Drägerwerk AG. Drägerwerk 
AG assumes all responsibilities as the sponsor of this study. 
 
 
 

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Coordinating Investigator:  PD Dr. med. Peter Spieth 
 
 Universitätskl
inikum Carl Gustav Carus 
 
 Dresden 
 
Medical Advisor: 
Associate Professor (USA)  
 
Dr. med. Ol
iver C. Radke 
 
 
Kl
inik für Anästhesiologie  
 
 und Operative Intensivmedizin 
 
 
Kl
inikum Bremerhaven-Reinkenheide gGmbH 
6.1.2 BLINDING 
This is an observational trial of intraindividual correlation between two 
methods of measurement. Since we do not al
locate patients to treatment and 
placebo groups as it would be the case in a randomized trial, bl
inding is not 
strictly necessary. However, patients wi
l
l be bl
inded to the results of the 
investigational EIT device by either a) being sedated in the ICU or under 
general anesthesia or b) device wi
l
l not be facing them so they cannot see the 
results.  
Study personnel at bedside wi
l
l not be bl
inded as they have to interact with 
the device (to ensure qual
ity of data recording) and therefore bl
inding is not 
feasible. 
The medical personal responsible for the patient´s medical care does not use 
the information given by the PulmoVista 500 . 
6.1.3 PRIMARY AND SECONDARY STUDY ENDPOINTS 
PRIMARY STUDY ENDPOINT 
The capabi
l
ity of PulmoVista 500 
for continuous monitoring of venti
lation and 
its changes at different points 
in time during varying states of regional 
venti
lation, the cross-correlation 
function (CCF) between global tidal 
impedance (EIT) waveforms and global tidal volume (venti
lator) curves wi
l
l be 
evaluated. 
SECONDARY STUDY ENDPOINTS  
- First secondary endpoint: To assess the capabi
l
ity of PulmoVista 500   
to detect changes in regional venti
lation by evaluating the cross 
correlation between impedance waveforms derived from PulmoVista 
500 and volume curves derived from venti
lator during one-lung-
venti
lation. 
- Assess that changes of tidal volumes 
induced by venti
lator settings can 
be monitored by the “Trends view” 
- Assess that changes of the end-expiratory lung volumes (induced by 
e.g. PEEP changes, recruitment and suctioning maneuvers) can be 
monitored by “dEELI trend view”  

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- Documentation of any safety events related to the use of PulmoVista 
500  
- Assessing the use specific clinical helpfulness of PulmoVista 500 - 
clinical helpfulness of PulmoVista 500 is proven if 
• see attachments (chapter 23.1) clinical usability 
6.1.4 INVESTIGATION OF ENDPOINTS 
The trial relevant data has to be recorded in time in the electronic CRF. The 
use of the eCRF (MACRO 4) makes it possible to provide the raw data in 
CDISC readable standard. Electronic data of EIT, CT-, MRI-images, ultrasound 
assessments and radiographs, only marked with the subject identification 
number, will also be transferred to the KKS cloud in patient specific folders. 
 
 
6.1.5 STUDY RELEVANT DEVICES 
The serial numbers of all used devices will be documented in the respective 
ISF and the TMF.  
The recording of the measurements will be pseudonymised. 
 
PulmoVista 500: This is a device that can measure and visualize global 
and regional impedance among a cross-section of a patient´s thorax. The 
device uses very low alternating currents administered to the patient´s 
chest through an electrode belt. The measurement is non-invasive, 
radiation free and yields results in real time (see above 2.4). 
 
Ventilator: A standard patient ventilator with a compatible data interface 
to PulmoVista 500 (e.g. Draeger V500 or Evita XL) to allow recording of 
ventilation data by PulmoVista 500  . 
 
Laptop: Standard laptop computer running software (Synology Cloud 
Station Drive, respective current version) to transfer data from 
PulmoVista 500 to the KKS cloud (imbcloud.medizin.tu-dresden.de).  
 
USB-Flashdrive to transfer the data determined during measurements to 
the statistician via laptop and KKS cloud (see above and below 
Datamanagement). Access to the Flashdrive  reserved to specially 
authorised users. 
6.1.6 PROCEDURES TO REPLACE PARTICIPANTS 
As this study does not have treatment arms, replacement of participants is 
not necessary. The calculated sample size includes a safety margin for 
dropouts. 
6.2 
CONCOMITTANT MEDICAL MANOUVERS 
The medical care of the patient will not be altered by this purely observational 
trial. We do however capture data while medical care is being altered (e.g. 
changes in ventilator settings), but these changes are in no way affected by 
the study protocol. 

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6.2.1 EXPOSITION TO MEDICAL DEVICE 
Al
l devices are approved acc. Medical Device Act and wi
l
l be used accordingly. 
Measurement with PulmoVista 500  during venti
lation shal
l last for a 
maximum of eight hours.   
6.2.2 USE OF MEDICAL DEVICE 
Al
l devices are used according to their intended purpose according to the user 
manuals and the standard training of the users (“Geräteeinweisung”). 
6.3 
PARTICIPANTS 
6.3.1 INCLUSION CRITERIA 
A potential subject wi
l
l be included in the study if he/she meets al
l of the 
fol
lowing inclusion criteria: 
 Male and female patients (18 years of age or older), 
 On respiratory support in ICU care or scheduled for such (e.g. 
postoperatively) or scheduled for surgery with OLV 
 Patients of which the monitoring of venti
lation distribution may be of 
cl
inical interest, 
 Patients being venti
lated via an artificial airway with a mechanical 
venti
lator that is compatible with PulmoVista 500 
 Patients scheduled for changes in venti
lation settings that may 
cause relevant changes in the venti
lation 
 Chest circumference between 70 and 150 cm, 
 Written informed consent to participate in the study provided by 
either the patient or the legal representative of the patient.  
6.3.2 EXCLUSION CRITERIA  
A potential subject wi
l
l be excluded from the study if he/she meets any of the 
fol
lowing criteria: 
 Currently has a permanent or temporary pacemaker, implantable 
cardiac device (ICD) or other device emitting electrical energy, 
 Has a BMI ≥ 50, 
 Has a tidal volume (VT) ≤ 200 mL, 
 Current uncontrol
led body movements such as tics, tremors or 
seizures,  
 Current wound dressings or infections on the chest that might 
interfere with the electrode belt placement, 
 Women of chi
ld bearing potential whose pregnancy cannot be 
excluded based on a pregnancy test or other proven facts. 
 Al
lergic to materials used in the electrode belt, 
 Participation of the patient in an interventional trial within the last 
four weeks before enrol
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 
Evidence suggesting that the patient or his legal representative is 
not likely to follow the trial protocol (e.g. lacking compliance), 
 
infectious diseases that require isolation of patient (e.g. MRSA), 
 
Concomitant use of an air anti-decubitus medical mattress with 
dynamic inflation that cannot be deactivated during EIT 
measurements. 
6.3.3 POPULATION AND INDICATION 
- Intensive care unit (ICU) patients, who are mechanically ventilated via an 
artificial airway (endotracheal tube or tracheostomy cannula) and who are 
expected to be subjected to major changes in their ventilator settings will 
be monitored with the PulmoVista 500  device before, during and after the 
changes. These changes in the ventilator settings should result in 
recognizable changes in the distribution of ventilation in the lungs. 
Examples of such interventions are: 
• 
Spontaneous breathing trial (SBT) using the ventilator  
 
(as opposed to SBT using a T-piece) 
• 
Switching between different modes of ventilation (e.g. volume 
 
controlled, pressure controlled, pressure support, CPAP) 
• 
Initial adjustment of ventilation after ICU admission  
• 
Weaning of ventilation in preparation of extubation 
• 
PEEP trials and recruitment maneuvers 
• 
Suctioning maneuvers 
-  Patients who are scheduled for surgeries that require blocking of one 
bronchus (e.g. one-lung-ventilation by insertion of a double lumen tube or 
bronchial blocker) 
6.3.4 DURATION AND TIMELINES OF THE CLINICAL 
INVESTIGATION 
Successful enrollment of the entire study cohort is expected to be completed 
within 12 months. 
6.3.5 DURATION PER PARTICIPANT 
Data acquisition per patient is anticipated to be completed within eight hours. 
Additional patients will be evaluated for any adverse events on day 1, 2 or 3 
after the study day. No further follow up for the purposes of the clinical study 
is required.  
6.3.6 NUMBER OF PARTICIPANTS 
A sample size of n=80 patients (including at least 25 patients with OLV) has 
been calculated with an assumed drop-out rate of 15%.  
6.3.7 RECRUITING TIMELINE 
Recruiting time (FPFV – LPFV): 01/2017 – 09/2017 

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6.4 
STUDY PROCEDURES 
6.4.1 VISIT 1 - SCREENING AND INFORMED CONSENT 
Patients are considered “enrol
led” when written informed consent has been 
obtained and al
l in- and exclusion criteria are appropriately met.  
6.4.1.1 PATIENTS WHO ARE NOT YET ADMITTED TO ICU 
Patients who are not jet admitted to ICU wi
l
l be screened preoperatively, e.g. 
during the preoperative evaluation by the anesthesiologist. The physicians 
responsible for the patients´ medical care wi
l
l inform the study team when 
the actual medical intervention is planned. Study personnel wi
l
l have a 
screening checkl
ist to 
identify patients who might be el
igible to participate 
(e.g. scheduled for thoracic surgery or patients who are scheduled for major 
surgery that most 
l
ikely requires postoperative sedation and weaning in the 
ICU).  
If patients confirm interest in participating in this study, investigator wi
l
l 
evaluate inclusion and exclusion criteria according to the checkl
ist. If al
l in- 
and exclusion criteria are appropriate, investigator wi
l
l explain the study 
protocol to the patient and obtain written consent. 
6.4.1.2 PATIENTS WHO ARE ALREADY IN THE ICU  
Patients who are already in the ICU wi
l
l be screened by study personnel by 
interviewing the physicians responsible for patient care in the ICU. Study 
personnel wi
l
l use a checkl
ist to determine if a patient is expected to undergo 
a change in venti
lation situation that is appropriate for 
inclusion in the study 
(e.g. spontaneous breathing trial, changes in PEEP settings). Study personnel 
wi
l
l then approach the patients´ 
legal representative (e.g. person in charge to 
explain the study protocol and obtain written consent. 
Demographic data, patients´ medical history and lab tests are obtained from 
the anesthesia record and the ICU chart as appropriate. The study protocol 
does not require any additional tests besides medical
ly indicated by the 
physicians in charge of the patients. 
6.4.2 VISIT 2 - MEDICAL AND STUDY MEASUREMENT 
6.4.2.1 PATIENTS CURRENTLY ON OR SCHEDULED FOR VENTILATOR 
CARE IN THE ICU 
The physicians responsible for the patients´ medical care wi
l
l inform the study 
team when the actual medical intervention is planned. Study team wi
l
l re-
evaluate whether al
l in- and exclusion criteria are appropriately met (e.g. sti
l
l 
intubated).  
Study team wi
l
l setup the investigational devices at least 30 minutes before 
the medical intervention to al
low for stable basel
ine readings and 
uninterrupted medical care. PulmoVista 500 electrode belt is placed around 
the patient´s chest, and the PulmoVista 500 
is connected to the venti
lator. 
Continuous recording of data 
is started and verified.  

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During the investigational phase, the study device wi
l
l continuously record al
l 
data. Before the study measurement, the study team wi
l
l record basel
ine 
readings for at 
least 5 minutes. During the study measurement, recording wi
l
l 
continue uninterrupted; exact time points of events (e.g. when vent settings 
are adjusted) and detai
ls of the study measurement (e.g. old and new vent 
settings) are recorded by the study personnel according to the clock 
in 
PulmoVista 500 (to ensure accurate timing with the recorded data). Recording 
of the data wi
l
l continue for at least 5 minutes after the medical intervention 
is completed.  
Once the recording is completed, electrode belt wi
l
l be removed 
from the 
patient and the investigational device wi
l
l be disconnected. 
6.4.2.2 PATIENTS SCHEDULED FOR ELECTIVE SURGERY WITH OLV 
Patients scheduled for elective surgery wi
l
l receive medical care according to 
the hospital´s establ
ished standards. Before anesthesia induction, study team 
wi
l
l re-evaluate whether al
l in- and exclusion criteria are appropriately met 
(e.g. sti
l
l intubated). Patients are considered “enrol
led” when written informed 
consent has been obtained and al
l in- and exclusion criteria are appropriately 
met. 
After arrival in the induction room, patients wi
l
l be connected to the 
appropriate monitors 
for routine patient care. Additional
ly, patients wi
l
l be 
asked to sit up and have the electrode belt of PulmoVista 500 fitted to their 
thorax according to the IfU. Investigational device is set up and connected to 
the patient and related devices.  
Before and during pre-oxygenation of the patient, study personnel wi
l
l start 
and test recording of the data. Anesthesia induction, placement and 
confirmation of correct placement of the DLT / bronchial blocker wi
l
l be 
performed according to the hospital´s establ
ished standards of care.  
In patients who require independent lung venti
lation during their surgical 
procedure, EIT measurements shal
l be performed during normal (both 
lungs) 
and single-lung venti
lation after induction of anesthesia before start of 
surgery. According to standard of care correct positioning of the DLT 
respectively of the bronchial blocker wi
l
l be tested by switching between 
normal venti
lation and single-lung venti
lation (right and left lung wi
l
l be 
tested 
independently). 
During the anesthesia induction, study personnel wi
l
l note the time of 
particular events (e.g. start of 
induction, mask venti
lation, intubation, 
clamping left/right) by using the clock on PulmoVista 500. The physician in 
charge of the anesthesia wi
l
l be asked to al
low uninterrupted basel
ine 
readings of at least 2 minutes after successful intubation and to keep the left 
and right lumen of the DLT clamped for at least 1 minutes each to ensure 
stable recording of the data. Each step of the testing of correct placement of 
the DLT or the bronchial blocker wi
l
l be marked 
in PulmoVista 500 before the 
conduct of this step.  

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Once data have been completely recorded and anesthesia induction is 
completed, the physician in charge will record approx. 2 minutes and stop the 
recording afterwards. The electrode belt will then be disconnected from the 
patient. This concludes the study for this particular patient. Typically, the 
patient is now transported to the operating room for their surgical procedure; 
this is not part of the study protocol. 
6.4.3 GENERAL 
In both cases, if the physicians responsible for the medical care of the patient 
decide that the data recording for the study purpose interferes with necessary 
medical care (e.g. in case of cardiac arrest), the data recording will 
immediately be stopped, the electrode belt removed and every effort will be 
undertaken to not interfere with the medical care. In this case, the patient will 
be considered a drop-out. 
All obtained data were recorded immediately in the eCRF provided by the KKS 
Dresden or were transferred to the KKS cloud.  
Electronic data of EIT, CT-, MRI-images, ultrasound assessments and 
radiographs, only marked with the subject identification number, will also be 
transferred to the KKS cloud. These data were not taken especially for this 
study, but due to necessary medical treatment. They will be used within this 
study if they were taken during the period of day –2 to +3. 
 
6.4.4 VISIT 3 - FOLLOW-UP-VISIT 
All patients who underwent data recording will be followed up once within 1-3 
days after visit 2. During this follow up visit, patients will be asked about any 
adverse events, and the patients´ thorax will be visually inspected for any 
irritation caused by the electrode belt. If patients are not able to answer (e.g. 
still sedated or unconscious), the physicians taking care of the patient are 
questioned about any adverse events. 
6.5 
RESPONSABILITYS OF SPONSOR AND INVESTIGATOR 
The Sponsor (Drägerwerk AG) has the overall responsibility for the clinical 
trial including initiation, organization, and financing (according to the German 
Medical Device Act). 
The sponsor and the clinical investigator assure that the clinical trial is 
performed in accordance with: 
 
DIN-EN-ISO 14155: 2011, 
 
Declaration of Helsinki concerning medical research in humans 
(Recommendations Guiding Physicians in Biomedical Research Involving 
Human Subjects, Helsinki 1964, amended Tokyo 1975, Venice 1983, 
Hong Kong 1989, Somerset West 1996, Edinburgh 2000, Washington 
2002, Tokyo 2004, Seoul 2008, Fortaleza 2013). 

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This trial must be carried out in compl
iance with the protocol. 
Al
l investigators are l
icensed to practice medicine and have at least two years 
work experience in intensive care and anesthesia. Al
l investigators have 
theoretical and practical experience in treating mechanical
ly venti
lated 
patients. 
Al
l investigators have theoretical and practical experience in conducting 
cl
inical trials and provide documented proof of GCP knowledge and/or 
investigator’s training as wel
l as knowledge of German Medical Devices Act.  
The Coordinating investigator must have at least two years of experience in 
conducting cl
inical trials. 
The investigator at each trial site is responsible for selecting and assembl
ing 
the study team members (especial
ly the medical staff) according to the 
requirements of this trial protocol. Furthermore, the investigator is 
responsible for training and supervision of the study team and providing al
l 
necessary information. This has to be documented. 
6.6 
MONITORING 
The investigator agrees that the monitor wi
l
l visit the trial site in appropriate 
intervals. During these visits the monitor wi
l
l check the qual
ity of the data 
recording and ensure that the trial site adheres to the timeframe as set in the 
study protocol. The investigators agree to provide any relevant information 
and documentation whenever the monitor requires that. This includes access 
to al
l original study documents and source data. 
It is the responsibi
l
ity of the investigator to keep the participant’s chart as 
complete as possible (e.g. history, concomitant diseases, inclusion in the 
cl
inical study, visit dates, results of laboratory tests, distribution of the study 
medication, and adverse events). Source data are checked and compared 
with entries in the data bank. The participant has given consent with this 
procedure by signing the patient information and written informed consent 
form. 
Tasks of the monitor and the qual
ity assurance wi
l
l be described in detai
l in a 
monitoring manual. 
The monitor has the responsibi
l
ity to treat al
l information confidential
ly and to 
safeguard the integrity and personal privacy of the study participants. 
7 
STATISTICAL CONSIDERSATIONS 
7.1 
SAMPLE SIZE, DROP-OUT-RATES, LEVEL OF SIGNIFICANCE AND 
POWER OF THE CLINICAL INVESTIGATION 
 

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Primary Endpoint (Efficacy) 
Based on former porcine trials7 with PulmoVista 500 and data from clinical 
studies with other EIT devices the sample size was calculated using the 
program G*Power 3.1.9.2.  
An α-error of p = 0.05 and a power = 0.9 in a two-sided testing resulted in a 
sample size of 68 patients. With this sample size a difference of 0.1 of the 
mean cross-correlation coefficient shall be detected, i.e. the true value of a 
calculated mean of 0.8 will not be smaller than 0.7 and not be larger than 0.9 
with the given p-value and power under the assumption of a standard 
deviation of less than .25.  
Accounting for 15 % potential drop-outs 80 patients shall be enrolled in the 
study. 
Secondary Endpoint (Efficacy) 
Based on former porcine trials with PulmoVista 500 and data from clinical 
studies with other EIT devices the sample size was calculated using the 
program G*Power 3.1.9.2. An -error of p = 0.05 and a power = 0.9 in a 
two-sided testing resulted in a sample size of 22 patients. With this sample 
size a difference of 0.1 of the proportion between reference and investigated 
variable shall be detected. 
Accounting for 15 % potential drop-outs 25 patients shall be enrolled in this 
subgroup of the study. 
7.2 
STATISTICAL DESIGN 
Null-Hypothesis 
The PulmoVista 500 is not capable of continuously monitoring ventilation. 
Primary Endpoint (Efficacy) 
To assess the capability of PulmoVista 500 for continuous monitoring of 
ventilation and its changes at different points in time during varying states of 
regional ventilation, the cross-correlation function (CCF) between global tidal 
impedance (EIT) waveforms and global tidal volume (ventilator) curves will 
be evaluated. 
 
To refute the null-hypothesis of this trial it must be shown that the global 
tidal impedance waveforms and the global tidal volume curves correlate 
                                        
7 Fischer E, Gremse F. Assessment of the capability of PulmoVista® 500 to continuously 
monitor regional ventilation distribution and its changes over time. An Animal Study. FINAL 
STUDY REPORT. PulmoVista 500-30022. Aix Scientifics. 2016-01-27 

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significantly, i.e. that the correlation scores are significantly different from 
zero. 
 
If the null-hypothesis is refuted the capability of PulmoVista 500 is 
assumed to be a valuable diagnostic device for long-term monitoring of 
mechanical ventilation.  
The mean value of the intra-subject cross-correlation function (CCF) between 
global impedance (EIT) waveforms and global volume (ventilator) curves will 
be determined. 
Secondary Endpoint (Efficacy) 
To assess the capability of PulmoVista 500 to detect regional changes of 
ventilation it shall be tested, whether EIT can correctly differentiate between 
normal and single-lung ventilation. 
 
 
To refute the null-hypothesis of this trial it must be shown that the 
regional information about tidal impedance variation matches the clinical 
changes from normal to single-lung ventilation, i.e. that EIT detects 
ventilation vs. no ventilation in each lung. 
 
If the null-hypothesis is refuted the capability of PulmoVista 500 is 
assumed to be a valuable diagnostic device for detecting regional 
ventilation changes during long-term monitoring of mechanical ventilation. 
The diagnostic output of the EIT measurements will be compared with clinical 
ventilation settings in a 2x2 table. 
7.3 
PASS/FAIL CRITERIA 
There is no pass/fail criteria defined. 
7.4 
INTERIM ANAYLSIS 
There is no interim analysis planned. 
7.5 
CRITERIA FOR THE TERMINATION OF THE CLINICAL 
INVESTIGATION ON STATISTICAL GROUNDS 
There are no termination criteria defined. 
7.6 
PROCEDURES FOR REPORTING ANY DEVIATIONS FROM 
ORIGINAL STATISTICAL PLAN 
Any deviations on the original statistical plan will be documented and any 
changes leads to a new version of the statistical plan.  

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7.7 
SPECIFICATION OF SUBGROUPS 
Twenty-five patients with OLV during anesthesia for thoracic surgery 
(secondary endpoint efficacy). 
7.8 
PROCEDURES THAT TAKE INTO ACCOUNT ALL DATA 
The Full Analysis Set (FAS) consists of all enrolled patients. This excludes 
non-informative drop-outs. A per protocol analysis may be specified in the 
statistical analysis plan excluding major protocol violations. 
Safety Analysis Population (SAP) consists of all enrolled patients who already 
were treated with the medical device (PulmoVista 500).  
7.9 
TREATMENT OF MISSING, UNUSED OR SPURIOUS DATA, 
INCLUDING DROP OUTS AND WITHDRAWALS 
No missing data imputation techniques will be applied, and patients with 
missing efficacy data will used as censored in the time to event analysis. 
Therefore any effort should be undertaken to avoid missing data, notably in 
case of the primary outcome measures. 
When a patient is withdrawn from the trial before the scheduled end of a 
measurement phase, and an end-of-study visit can be performed, the data of 
this visit will be used for computing the primary outcome measure. 
The handling of missing data will be specified in the SAP prior to the final 
statistical analysis based on assumptions on the respective missingness 
mechanisms or in the Data Review Meeting. 
8 
DATA UND DATAMANAGMENT 
The electronic Case report Form (eCRF) for capture of the pseudonymised 
study specific data according to the protocol, will be designed by the KKS 
Dresden in cooperation with the Medical Advisor. The eCRF will be programed 
and validated at a clinical study database with the EDC study specific software 
MACRO 4.0 (Elsevier) according ICH-GCP and to the Standard Operating 
Procedures (SOPs) of the KKS Dresden.  
During the whole course of the study, a backup of all data is made on a daily 
basis. Unauthorized access to patient and site data is prevented by the access 
concept of the study database which is based on a strict hierarchy and role 
model and managed by KKS Dresden.  
The investigator has to authorize member(s) of the study team at the study 
site(s) for data capture and sign of eCRF data. This authorization has to be 
supplied via Staff Signature and Delegation Log to the KKS for setup the user 
at the database. The study specific data will be entered directly into the 

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database via eCRF data entry masks by authorized member of the study 
team.  
The eCRF will be filled in shortly after each study visit. Each eCRF Visit will be 
signed electronically by an investigator or a therefore authorised member of 
the study team by their login identification. This represents the electronic 
equivalent of a signature on paper and confirms accuracy and authenticity of 
all data on the eCRF. 
An eCRF will be provided for each patient. The patient will be identified as per 
the Patient-ID only. All information required by the protocol and therefore 
collected during the clinical trial must be recorded by an investigator or an 
authorised member of the study team as source data in the source 
documentation for the study. 
Source data according to DIN EN ISO 14155:2012-01 are defined as all 
information in original records, certified copies of original records of clinical 
findings, observations, or other activities in a clinical investigation, necessary 
for the reconstruction and evaluation of the clinical investigation. Source data 
are contained in source documents (original records or certified copies). It is 
defined for each trial site, what source data for respective eCRF entries are 
and where these are filed (Source Data Agreement). 
Data recorded in the PV500 are only marked with the subject identification 
number (see below 8.2). At the end of every visit 2, when the patient is no 
longer connected to the PulmoVista 500, the new data will be transferred to 
the study laptop and were synchronized with the site folder in the KKS cloud. 
The synchronization will be performed via an encrypted connection. For data 
transfer between PulmoVista 500 and study laptop a standard USB-Flashdrive 
will be used.  
Electronic data of CT-, MRI-images, ultrasound assessments and radiographs, 
only marked with the subject identification number, will also be transferred as 
described above. 
At the end of the trial a final check of all collected data (via KKS Cloud) will be 
performed.  
However, the Investigator has final responsibility at all times for the 
accuracy and authenticity of all clinical and laboratory data entered in the 
eCRF. 
At the end of the study the Investigator will receive the trial specific data 
including the audit trail concerning his/her investigational site on electronic 
data storage. 
8.1 
PROCEDURES USED FOR DATA REVIEW, DATABASE CLEANING, 
AND ISSUING AND RESOLVING DATA QUERIES 
The review of these data will be performed by the programmed ranges-, 
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generated discrepancies, by the database, monitoring or data management 
have to be answered by the authorized member of the study team. 
Al
l changes of each data wi
l
l be tracked with the old and changed value by 
username, reason for change, date- and timestamp (audit trai
l) of authorized 
member of study team.  
At the end of the study, once the database has been declared complete and 
accurate, the database wi
l
l be locked. Thereafter, any changes to the 
database are possible only by joint written agreement between coordinating 
investigator, biometrician and data manager. 
8.2 
SUBJECT IDENTIFICATION NUMBER 
Patients fulfi
l
l
ing the inclusion and exclusion criteria wi
l
l get an identification 
number at registration. Subject ID number consists on a combination of site 
ID number (XX) and a sequential number for each subject (YYY, starting with 
“001” at each site).  
An example: Subject ID: 02-003  
8.3 
VALIDATION AND SECURING ELECTRONIC DATABASE SYSTEMS 
MACRO 4.0 is running in a val
idated state in a control
led environment and 
corresponds to al
l requirements from FDA 21 CFR Part 11 and EU GMP Annex 
11. MACRO is running behind a firewall with separated appl
ication and 
database servers. 
8.4 
ARCHIVING OF DATA AND DURATION 
Al
l essential cl
inical investigation documentation (Trial Master Fi
le), the 
electronical
ly stored data, the study specific eCRF data inclusive the audit trai
l 
on an electronic data media and the final report wi
l
l be stored for at least 10 
years at the Sponsor after the investigation’s completion.  
At the trial sites, the investigators’ fi
les, patient identification l
ists, signed 
written consent forms, the study specific eCRF data inclusive the audit trai
l on 
an electronic data media and the patients’ fi
les wi
l
l be stored for at least 10 
years after the investigation’s completion. If local rules or other legal 
requirements require longer periods of archiving, then these have to be met. 
9 
AMENDMENTS 
No changes in the study procedures shal
l be effected without mutual 
agreement of the coordinating investigator and the sponsor. Al
l changes must 
be documented by signed cl
inical protocol amendments. Substantial changes 
may require approval from the EC (as appl
icable) prior to implementation. 
Under emergency circumstances, deviations from the trial protocol to protect 
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prior approval of the sponsor. Such deviations shall be documented and 
reported to the sponsor.  
Changes made to the protocol that were appraised positively by the Ethics 
Committee must be positively reappraised and approved if the changes 
- 
are such that they may affect the subjects' safety, e.g. fundamental 
changes to the therapeutic or diagnostic procedures, 
- 
result in further data collection that necessitates changes to the patient 
information and/or Informed Consent Form, 
- 
affect the interpretation of the scientific documents upon which the trial 
is based or the significance of the results of the trial, 
- 
significantly affect the leadership or conduct of the trial, 
- 
concern the quality or the innocuousness of the medical device. 
10 
ADHERENCE TO THE PROTOCOL 
After a patient has been enrolled, it is the investigator's responsibility to avoid 
protocol violation in order to obtain unbiased data for the trial. 
All protocol violations must be documented by the investigator. Those 
protocol violations that are to be deemed major will be reported to the 
coordinating investigator and to the sponsor immediately.  
Minor variations are inevitability, but must be documented together with a 
justification. 
All protocol violations will be discussed with the responsible biometrician 
before closing the data bank and carrying out the statistical analysis.  
The reason for a violation shall be clarified to avoid this in future. 
The investigator must ensure that the recorded data are documented as per 
protocol.  
11 
DEVICE ACCOUNTABILITY 
The Serial number of every provided Medical Devices and accessory 
component per patient (electrical cables, electrode belt, trunk cable) for each 
trial site will be documented in the delivery notifications and stored in TMF 
and ISF.  

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12 
STATEMENTS OF COMPLIANCE, 
INSURANCE 
12.1 
STATEMENT OF COMPLIANCE 
The sponsor and the clinical investigator assure that the clinical trial is 
performed in accordance with: 
 Declaration of Helsinki concerning medical research in humans 
(Recommendations Guiding Physicians in Biomedical Research Involving 
Human Subjects, Helsinki 1964, amended Tokyo 1975, Venice 1983, 
Hong Kong 1989, Somerset West 1996, Edinburgh 2000, Washington 
2002, Tokyo 2004, Seoul 2008, Fortaleza 2013), 
 National and local regulations. 
This trial must be carried out in compliance with the protocol and in 
accordance with the sponsor's standard operating procedures. The 
investigator agrees, when signing the protocol, to adhere to the instructions 
and procedures described in it and thereby to adhere to the principles of DIN 
EN ISO 14155:2012-01. 
The responsibilities of the investigator include: 
 
understanding of the properties of the trial medical device as described 
in the trial description 
 
execution of the measurement plan, 
 
providing sufficient time and capacity to perform the clinical trial, 
 
correct collection and documentation of trial related data and reporting, 
 
provision of data to the sponsor, for the monitor, and for 
audits/inspections, 
 
ensuring strict confidentiality and requesting similar confidentiality from 
her/his staff concerning information about participants and information 
provided by the sponsor. Trial documents provided by the sponsor 
(protocols, CRFs and other material) will be stored appropriately to 
ensure their confidentiality. The information provided by the sponsor to 
the investigator may not be disclosed to others without direct written 
authorization from the sponsor, except to the extent necessary to 
obtain informed consent from patients who wish to participate in the 
trial, 
 
The clinical investigator has full responsibility for the conduct of the 
clinical trial in the trial center. 

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12.2 INSURANCE 
As this study is a non-risk study (medical device is CE certified and it is used 
according to its approved intended use. The study does not expose the 
patient to any harmful or stressful interventions) which is to be approved 
according to the §23b of the German Medical Device Act (MPG), insurance is 
covered by the sponsor’s general product labi
l
ity insurance. 
 
This insurance is provided by the fol
lowing insurer: 
HDI Global SE 
Hamburg Branch 
Überseering 10a 
22297 Hamburg 
Germany 
Policy Number: 20000536 01055 114 
 
The sponsor insurance department is to be contacted at: 
Drägerwerk AG & Co. KGaA 
Corporate Insurance 
Mr. Andy Martens 
Moislinger Allee 53-55 
23558 Lübeck 
Germany 
phone: +49 451 882 5060 
13 INFORMED CONSENT PROCESS 
The patient’s informed consent must refer expl
icitly to the col
lection and 
processing of health-related data. Therefore the patient should be informed 
expl
icitly about the purpose of col
lecting the data and scope of what is to be 
col
lected and that personal data, in particular those related to health, wi
l
l be 
used.  
The investigator must obtain written informed consent from the patient for 
his/her inclusion in the study, after explaining the rationale for and the 
detai
ls, aims and objectives of the study, the risks and benefits of alternative 
measurements, and the extent of the patient’s involvement. The patient shal
l 
have time to read and understand the Informed Consent, and shal
l personal
ly 
date and sign the Informed Consent. The patient should also be provided a 
copy of the signed Informed Consent.  
The investigator is responsible for ensuring that no patient is subject to any 
study-related examination or activity before the patient has given his/her 
written informed consent. 
After obtaining signature of the patient, duly signed informed consents, as 
wel
l as written information given to patients, shal
l be kept and archived in the 

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Investigator fi
le for a minimum of 10 years after completion of the 
investigation.  
Al
l information provided to patients including any advertisements for the 
cl
inical investigation within the cl
inical trial sites or in the publ
ic press needs 
approval of both sponsor and EC prior to being presented to the patients 
under any format. 
If new information becomes avai
lable that can significantly affect a subject’s 
future health and medical care that information shal
l be provided to the 
subject(s) in written form. If relevant, al
l affected subjects shal
l be asked to 
confirm their continuing informed consent in writing. 
Informed consent process with subjects who are not able to give written 
informed consent wi
l
l be carried out by the subject´s legal representative. 
(6.4.1.2) 
14 ADVERSE EVENTS, ADVERSE DEVICE 
EFFECTS AND DEVICE DEFICIENCIES  
14.1 DEFINITION ADVERSE EVENT (AE) 
Adverse events are defined in accordance with ISO 14155:2011. That is, an 
Adverse Event (AE) is any untoward medical occurrence, unintended disease 
or injury, or any untoward cl
inical signs (including cl
inical
ly significant 
abnormal laboratory findings) in subjects, users or other persons, whether or 
not the adverse event is related to the used medical device.  This definition 
includes events related to the medical device or events related to the 
procedures involved in the study. 
Medical conditions present at basel
ine wi
l
l not be recorded as adverse events 
during the study unless they deteriorate, becoming more severe or more 
frequent. 
14.2 DOCUMENTATION AND REPORTING OF AE(S) 
Information on AEs wi
l
l be col
lected from the time of enrol
lment unti
l regular 
completion of study, death or withdrawal (whichever comes first). The 
investigator wi
l
l report al
l AEs as soon as possible (preferably within 7 days of 
the site’s knowledge of the event) by entering them in to the eCRF. 
AEs are documented on an AE form (eCRF). Diagnosis, onset, and end of the 
AE, seriousness, severity, causal relationship with the investigational medical 
device, with the study procedures, treatment of the AE, and the outcome of 
the event wi
l
l be documented. The Investigator wi
l
l fol
low-up the event unti
l 
the AE has been resolved, resolved with sequelae or was fatal. 

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15 SERIOUS ADVERSE EVENTS (SAE)  
Information on Serious Adverse Events wi
l
l be col
lected from the time of visit 
2 unti
l visit 3. 
A Serious Adverse Event (SAE) is in accordance with ISO 14155 an AE that 
led to death, led to serious deterioration in the health of a subject that 
resulted in either a l
ife threatening i
l
lness or injury, or permanent impairment 
of a body structure or a body function, in-patient or prolonged hospital
isation 
or medical or surgical intervention to prevent l
ife-threatening i
l
lness or 
permanent impairment to a body structure or body function or led to foetal 
distress, foetal death or a congenital abnormal
ity or birth defect. 
Planned hospital
isations for pre-existing conditions or a procedure required by 
the protocol, without serious deterioration in health, is not considered a 
serious event. If hospital
isation or extension of hospital
isation results as a 
consequence of a compl
ication in a pre-existing condition or a procedure 
required by the protocol then it wi
l
l be recorded as an SAE. 
Note: This includes device deficiencies that might have led to a serious 
adverse event if a) suitable action had not been taken or b) intervention had 
not been made or c) if circumstances had been less fortunate. 
15.1 DOCUMENTATION AND NOTIFICATION OF SAE – 
INVESTIGATORS RESPONSIBILITY 
Serious Adverse Events wi
l
l be documented on the eCRF.  
They must be documented in the eCRF immediately and not later than 24 
hours after the investigator’s knowledge of the event. Fol
low-up information 
should also be reported immediately after awareness. 
The Sponsor wi
l
l have read authorization for the eCRF. In this way the 
Sponsor wi
l
l get timely information by the system. 
16 DEVICE DEFICIENCY (DD) 
16.1 DEFINITION DEVICE DEFICIENCY (DD) 
Device deficiencies (DDs) are defined in accordance with ISO 14155 as any 
inadequacy of a medical device with respect to its identity, qual
ity, durabi
l
ity, 
rel
iabi
l
ity safety or performance, including malfunctions, use errors, and 
inadequate label
l
ing. 
A malfunction is defined as fai
lure of an investigational medical device to 
perform in accordance with its intended purpose when used in accordance 
with the instructions for use or protocol. 

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Al
l device deficiencies shal
l be documented during the clinical investigation 
and reported to the sponsor as soon as possible (preferably within 7 days of 
the site’s knowledge of the event) by entering them in to the eCRF. 
Drägerwerk AG & Co. KGaA wi
l
l be informed about device deficiencies as 
described in the Vigi
lance-Plan of the Study. 
16.2 DEFINITION AND REPORTING OF INCIDENT 
An incident is a malfunction, fai
lure or a modification of the features or 
performance or an inaccurate label or instruction manual for a medical device, 
which directly or indirectly caused, may have caused in the past, or may 
cause in the future, death or a serious aggravation of the state of health of a 
patient, a user or another person (MPSV § 2 (1)). 
As per MPSV §3 (2)  those responsible for the first placing on the market of 
medical devices are obl
igated to report incidents that occur in Germany as 
wel
l as product recal
ls taking place in Germany to the Federal Institute for 
Drugs and Medical Devices (BfArM). Reporting must be performed 
analogously for incidents that occur in al
l other participating European 
Countries to the responsible Authorities. 
As per MPSV §3 (2) the Investigator also has to report any incident 
immediately to his Competent Authority and in paral
lel to the manufacturer 
using the forms provided by the BfArM for Germany and the equivalents for 
al
l other participating countries. 
Incidents related to the PulmoVista 500 system or other medical devices 
provided by Dräger have to be reported by the investigator to: 
Drägerwerk AG & Co. KGaA   
Moisl
inger Al
lee 53-55 
23558 Lübeck, Germany 
Fax: +49 451 882-3018 
E-Mai
l: complaint.medical@draeger.com 
 
Incidents related to al
l other medical devices used within the trial have to be 
reported by the investigator to the respective manufacturer as per cl
inical 
routine procedures.  
The Investigator is informed about the Timel
ines according to the German 
MPSV §5 (1-2). 
16.3 DEVICE COMPLAINTS 
Device complaints (DCs) are any device deficiencies with regard to the study 
device, instructions for use, operator’s manual and other product related 
documentation. Device complaints may or may not involve a cl
inical event. 
Any complaints on the device, instructions for use, operator's manual and 
other product related documentation regarding the PulmoVista 500 system 
shal
l be reported by the investigator to Drägerwerk AG using the appropriate 

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reporting forms. Whenever possible in case of malfunction of the study device 
or part of the study device, the product in question shall be returned to 
Drägerwerk AG for investigation. The appropriate procedure for such return 
shall be installed by Drägerwerk AG prior to starting the clinical investigation. 
In case the device complaint resulted in serious or non-serious harm of the 
patient, an AE/SAE/Incident has to be reported as described in previous 
sections. 
16.4 
LIST OF FORESEEABLE ADVERSE EVENTS AND ANTICIPATED 
ADVERSE DEVICE EFFECTS  
It is conceivable that the reusable electrode belt of the PulmoVista 500 carries 
pathogens from one patient to another, causing infections in a study patient. 
In order to minimize this risk, we a) exclude any patients with multiresistant 
pathogens that require isolation of the patient (e.g. MRSA) and b) establish a 
standardized protocol for proper disinfection of the electrode belt after each 
use according to the IfU. 
The electrode belt consists of a silicone belt with embedded carbonized 
silicone electrodes. The electrodes shall coated with a conductive gel before 
each use to improve coupling with the patient´s skin (similar to the procedure 
during EEG recordings). The belt and the gel could potentially cause 
mechanical and chemical irritation of the patient´s skin. During pre- and post-
marketing surveillance of the product, Dräger has never encountered such an 
event, so we consider this risk to be negligible. 
As the study device is CE certified, the sponsor has conducted intensive risk 
analysis procedures.  
The official risk management report concluded that no unacceptable individual 
or overall residual risk while using the device is existing.  
16.5 
EMERGENCY CONTACT POINTS  
Safety Management 
Drägerwerk AG & Co. KGaA 
Complaint Handling 
Moislinger Allee 53-55 
 
23558 Lübeck, Germany 
 
Phone:  +49 451 882-5171 
Fax: +49 451 882-3018 
E-Mail: complaint.medical@draeger.com 
 
Sponsor 
 
Drägerwerk AG & Co. KGaA 
 
 
Clinical Affairs 
 
 
Moislinger Allee 53-55 
 
23558 Lübeck, Germany 
 
Phone:  +49 451 882-2888 

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Fax: +49 451 882-72888 
 
Ethikkommissionen 
Ethikkommission an der TU Dresden 
Fetscherstr. 74 
01307 Dresden 
Tel.: (0351) 458 2992 
Fax: (0351) 458 4369 
ethikkommission@mailbox.tu-dresden.de 
 
Ethik-Kommission der MHH 
- OE 9515 - 
Carl-Neuberg-Str. 1, 30625 Hannover 
 
Telefon 0511 / 532-3443  
Fax: 0511 / 532-16 3443  
Ethikkommission@mh-hannover.de 
16.6 
EMERGENCY PROCEDURES 
Because no emergency is expected, no specials procedures are determined. 
If, contrary to all expectations an emergency should happen, the patient will 
receive all necessary medical treatment. 
16.7 
FOLLOW UP OF PARTICIPANTS 
After termination of the trial participation (visit3 or withdrawal of the informed 
consent) patient will get appropriate medical treatment. 
17 
VULNERABLE POPULATION UNDER 
PRESSURE  
This clinical trial will not include particularly vulnerable individuals.  
18 
PREMATURE TERMINATION OR 
SUSPENSION OF CLINICAL 
INVESTIGATION 
18.1 
CRITERIA FOR  PREMATURE TERMINATION OR SUSPENSION OF 
CLINICAL INVESTIGATION 
18.1.1 INDIVIDUAL 
The only circumstances in which a premature study termination (i.e. no 
further study visits) takes place in a patient are: 

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 
withdrawal of informed consent, 
 
complete loss of contact to the patient, 
 
impossibility to use the medical device (PulmoVista 500) or 
 
death of the patient.  
Note that impossibility to use the device, device failure, i.e. complete loss of 
function beyond repair implying final termination of device use in the patient, 
does not lead to individual study termination.  
Each premature termination of the trial has to be documented by the 
responsible investigator. If possible date, circumstances of, reason for the 
termination, and - if applicable - the final status of patient should be 
documented in detail in source documents and eCRF. 
18.1.2 OVERALL 
The sponsor has the right to discontinue the trial due to relevant medical or 
administrative reasons.  
Possible reasons for discontinuation by the sponsor are: 
 
failure in recruiting participants, 
 
insufficient data quality, 
 
unforeseen circumstances at the trial site that make the continuation of 
the trial impossible, 
 
occurrence of unjustifiable risks or toxicity, 
 
new scientific knowledge that does not justify continuation of the clinical 
trial. 
Trial discontinuation will be decided by the sponsor in cooperation with the 
investigator. 
18.2 
PROCEDURES FOR PREMATURE TERMINATION OR SUSPENSION 
OF A SINGLE SITE 
The sponsor has also the right to discontinue the participation of a site for one 
of the following reasons: 
 
failure in recruiting participants  
 
insufficient data quality  
 
no adherence to the protocol.  
18.3 
PROCEDURES FOR PREMATURE TERMINATION OR SUSPENSION 
The responsible ethics committee will be informed of the situation and the 
reason for the decision. The sponsor will pick up the study equipment and the 
investigator has to complete the documentation. 
A final report will be created on the basis of the contained data. 

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19 PLANNED TERMINATION OF CLINICAL 
INVESTIGATION 
The cl
inical investigation report should be provided to the EC`s within 12 
months after study termination. Planned Study termination wi
l
l defined as last 
patient last visit (LPLV). 
20 DATA SECURITY AND PUBLICATION 
POLICY 
20.1 PATIENT IDENTIFICATION AND CONFIDENTIALITY 
Within this study, personal data from the investigation subjects (name, 
initials, date of birth) and data regarding the therapy and the course of 
disease (medical results, types of therapy) wi
l
l be col
lected in the trial site. 
The identity of subjects enrol
led in the study and the information contained in 
their study records wi
l
l be kept confidential. The data wi
l
l be stored and 
processed in pseudonymized form (i.e. without reference to the patient’s 
name) with the aid of an identification number.  
Since in the course of the investigation contact between the trial site and the 
patients is necessary, the patients’ ful
l name, address and telephone number 
wi
l
l be ascertained and stored after obtaining written permission to do so. 
This information wi
l
l be stored separately from the investigation data.  
Data wi
l
l be analysed at the KKS Dresden. The safety concept ensures 
amongst other things that data access is l
imited to authorized persons, that 
measures are taken to prevent loss of data and that the laws pertaining to 
data protection are observed. The data are protected from third party access 
and only members of the investigation are permitted access. These members 
are sworn to secrecy.  
In the event of withdrawal of consent, the investigation subject´s stored data 
must be deleted if this is requested by the subject. 
20.2 DECLARATION REGARDING DATA PROTECTION 
During data entry, processing and analysis in the KKS Dresden, Fetscherstr. 
74, 01307 Dresden, al
l requirements of the data protection act wi
l
l be taken 
into account. Access to the data is strictly l
imited to authorized persons. Data 
are protected against unauthorized access. 

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20.3 
DECLARATION REGARDING THE PSEUDONYMIZED TRANSFER 
OF PERSONAL DATA  
The sponsor certifies herewith that the transfer of pseudonymized personal 
data will take place according to the documentation and communication 
regulations in MPKPV-guideline §10 (5). Moreover, the sponsor certifies that 
persons who do not permit the transfer of data will not be admitted to the 
investigation. 
20.4 
PUBLICATION POLICY  
The PV500 shall be published under the lead of the sponsor together with 
contributing partners Details are governed by a contract. 
Additional projects not predefined in this protocol might arise during the 
study. Results of those projects might be published only after publication of 
the predefined projects, unless the responsible authors are unable to 
complete the respective paper within one year after the end of the study. All 
not predefined projects will require approval by the sponsor. 
All additional publications must refer to the PV500-Trial  
Prior to study start, the clinical trial will be registered in a public trial registry 
(ClinicalTrials.gov). 
 
 

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Clinical Investigation Plan 
 
 
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22 
Bibliography 
1. Teschner E, Imhoff M, Leonhardt S. Electrical Impedance Tomography: 
The realisation of regional ventilation monitoring. Drägerwerk AG & Co. 
KGaA 2015; Reference-Nbr 90 66 788; 19. 
2. Rubenfeld GD. Epidemiology of acute lung injury. Crit Care Med 2003; 
31:S276-S284. 
3. Brun-Buisson C, Minelli C, Bertolini G, Brazzi L, Pimentel J, Lewandowski 
K, Bion J, Romand JA, Villar J, Thorsteinsson A, Damas P, Armaganidis A, 
Lemaire F; ALIVE Study Group. Epidemiology and outcome of acute lung 
injury in European intensive care units. Intensive Care Med 2004; 30:4-6. 
4. Goss CH, Brower RG, Hudson LD, Rubenfeld GD; ARDS Network. 
Incidence of acute lung injury in the United States. Crit Care Med 
2003;31:1607-11. 
5. Gattinoni L, Pesenti A, Bombino M, Baglioni S, Rivolta M, Rossi F, Rossi G, 
Fumagalli R, Marcolin M, Mascheroni D, Torresin A. Relationships between 
lung computed tomographic density, gas exchange, and PEEP in Acute 
Respiratory Failure. Anesthesiology 1988; 69: 824-832. 
6. Spiro SG, Silvestri GA, Agusti A (2012). Clinical Respiratory Medicine. (4th 
edition) Elsevier, ISBN-13- 9781455707928. 
7. Fischer E, Gremse F. Assessment of the capability of PulmoVista® 500 to 
continuously monitor regional ventilation distribution and its changes over 
time. An Animal Study. FINAL STUDY REPORT. PulmoVista 500-30022. Aix 
Scientifics. 2016-01-27. 
 
 

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Clinical Investigation Plan 
 
 
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23 Attachments 
23.1 Clinical Usability Questionaire 
Note:  
This test specification is intended to val
idate the cl
inical usabi
l
ity of the 
information on venti
lation distribution and lung volume changes which is 
displayed by PulmoVista 500. 
 
 
Please respond the fol
lowing questions in eCRF if this not interfere your 
cl
inical routine.  
 
1. Select the View "Main".  
How easy is it to identify within the Tidal Image, whether the 
right and the left lung are evenly ventilated? 
 
2. Select the View "Main".  
How easy is 
it to quantify the regional ventilation distribution as 
expressed by the regional parameters TV ROI 1 - TV ROI 4? 
 
3. Select the view "End-Insp. trend",  
Put cursor C1 before and cursor C2 after the intervention; View 
the differential image and the parameters in the trend table. 
How easy is it to set the cursors to respective positions which 
allow you to compare ventilation distribution before and after the 
intervention? 
 
4. Select the view “End-Insp. trend ",  
Put cursor C1 before and cursor C2 after the intervention; View 
the differential image and the parameters in the trend table. 
How easy is it to detect increases and/or decreases of regional 
ventilation? 
 
5. Select the view “End-Insp. trend ",  
Observe the global impedance waveform, and the graphical 
Medibus trend below the waveform and the trend table. 
How easy is it to relate the regional ventilation distribution and 
the corresponding parameters from the ventilator to each other? 
 
6. Select the view "End-Insp. trend ",  
Put cursor C1 before and cursor C2 after the intervention; View 
the differential image and the parameters in the trend table. 
How useful 
is the clinical 
information on ventilation redistribution 
caused by this intervention? 
 
 
 

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Clinical Investigation Plan 
 
 
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7. Select the view "ΔEELI trend",  
Put cursor C1 before and cursor C2 after the intervention; View 
the differential image and the dEELI parameters. 
How easy is it to set the cursors to respective positions which 
allows you assessing lung volume changes induced by the 
intervention? 
8. Select the view "ΔEELI trend",  
Put cursor C1 before and cursor C2 after the intervention; View 
the impedance waveforms, the differential image and the dEELI 
parameters. 
How easy is it to detect increases and/or decreases of regional 
lung volume? 
9. Select the view "ΔEELI trend",  
Put cursor C1 before and cursor C2 after the intervention; View 
the differential image and the dEELI parameters. 
How useful is the clinical information on regional lung volume 
changes caused by this intervention? 
 
23.2 Clinical Plausability Questionaire 
Questions addressing the regional aspects of the secondary endpoints 
 
One of the major purposes of the pivotal cl
inical study  
 
Assessment of the capability of PulmoVista 500 to continuously 
monitor changes of ventilation over time is to assess the plausibi
l
ity of 
the regional information, which cannot be val
idated by CT scans.  
 
The fol
lowing questions are intended to val
idate, whether 
 
 the regional information provided by PulmoVista 500 
is plausible in the 
presence of certain lung conditions, which are visible in CXR or lung 
CT and known to cause poor venti
lation 
 PulmoVista 500 
is capable of displaying changes of lung conditions 
induced by therapeutic interventions 
 those changes are plausible and correspond to the information that an 
experienced user would expect based on his knowledge about lung 
physiology 
 
Please respond the fol
lowing questions in eCRF if this does not interfere with 
your cl
inical routine.  
 
 
1. Select the view „Main“. 
Does the Tidal Image indicate poorly or non-venti
lated lung regions 
and does this location approximately match with those regions, where 
CXR or 
lung CT shows either lung col
lapse, atelectasis or pleura 
effusion? 
 

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Clinical Investigation Plan 
 
 
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Version 1.0 F, 21 November 2016 
2. Select the view "Main" and observe the Tidal Image, while one of the 
lungs is blocked. 
Does the Tidal Image correctly indicate which side of the lung is not 
being ventilated? 
 
3. Open the view "dEELI trend" after the PEEP setting has been 
changed. Set C1 at the lower and C2 at the higher PEEP level. 
Does the image dEELI: C2 minus C1 show the expected increase of 
endexp.lung volume in turquoise (light blue) color? 
 
4. Open the view "End-insp. trend" after the PEEP setting has been 
changed significantly (2 mbar or more). Set C1 at the lower and C2 at 
the higher PEEP level. 
Does the image Change: C2 minus C1 and/or the corresponding 
regional Tidal Variations show the expected redistribution of ventilation 
from ventral to dorsal? 
 
5. Open the view "dEELI trend" after lung suction has been conducted. 
Set C1 at a phase before and C2 during or immediately after the lung 
suction. 
Does the image dEELI: C2 minus C1 show the expected decrease of 
lung volume in orange color? 
 
6. Select the view "Main" and observe the Tidal Image from a patient 
with pneumonectomy. 
Does the Tidal Image properly indicate the non-ventilated lung regions 
and does the location approximately match with those region, where 
the lung has been removed?