Clinical trial NCT03076983: Assessment of the Capability of PulmoVista 500 to Continuously Monitor Changes of Ventilation Over Time
Official title: Assessment of the Capability of PulmoVista 500 to Continuously Monitor Changes of Ventilation Over Time
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation
Single-lung Ventilation
ARDS
ALI - Acute Lung Injury
Weaning From Ventilator
Keywords: Ventilation Monitoring
Electrical Impedance Tomography
Lead sponsor: Drägerwerk AG & Co. KGaA
Sponsor class: INDUSTRY
Collaborators: name: Technische Universität Dresden
First posted: 2017-03-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

AND Patients who are scheduled for surgeries that require blocking of one bronchus

Brief summary: The results of this study will help to define the capability and reliability of PulmoVista 500 to detect changes in both global and regional ventilation.


Eligibility criteria: Inclusion Criteria

- The population included in the clinical study will be selected from a pool of patients undergoing respiratory support who are scheduled to have their ventilation settings changed.

As a subgroup, patients who are scheduled for surgeries that need one-lung-ventilation (OLV) will be enrolled 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 ventilation distribution may be of clinical interest
* Patients being ventilated via an artificial airway with a mechanical ventilator that is compatible with PulmoVista 500
* Patients scheduled for changes in ventilation settings that may cause relevant changes in the ventilation
* 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 uncontrolled 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 child bearing potential whose pregnancy cannot be excluded based on a pregnancy test or other proven facts.
* 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

Primary outcomes:
measure: Monitoring Capabilities of PulmoVista 500
timeFrame: Day 1
Secondary outcomes:
measure: Detection of Changes in Regional Ventilation
timeFrame: Day 1
measure: Assess Changes of Tidal Volumes
timeFrame: Day 1
measure: Assess Changes of the End-expiratory Lung Volumes
timeFrame: Day 1
measure: Safety - Documentation of Any Safety Events
timeFrame: Day 1
measure: Assessing the Use Specific Clinical Helpfulness of PulmoVista 500 by Particular Questionnaire. The Questions Which Were Asked Within the Questionaire Are Listed in the "Outcome Measure Description"
timeFrame: Day 1
Other outcomes:
Locations:
city: Bremerhaven
country: Germany
facility: Klinikum Bremerhaven-Reinkenheide gGmbH
city: Dresden
country: Germany
facility: Universitätsklinik Dresden
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover (MHH)
Study officials:
affiliation: Universitätsklinikum Dresden
name: Peter M Spieth, Prof.Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum Bremerhaven-Reinkenheide gGmbH
name: Oliver C Radke, Prof. Dr.
role: STUDY_CHAIR
References: