Evaluation of a Disposable Flexible Bronchoscope, (aScope IV) a Randomized, Controlled, Cross-over Trial
Phase: NA
Conditions: Respiratory Insufficiency, Pneumonia, Atelectasis
Sponsor: University of Louisville

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Protocol Title:  
Evaluation of a disposable flexible bronchoscope, a 
randomized, controlled, cross-over trial  
 
 
 
 
 
 Principal Investigator: Rainer Lenhardt, MD 
 Co-Investigators:          Ozan Akca, MD   
 
 
 
 
         Rana Latif, MD  
 
 
 
 Medical Device: Ambu aScope 3 
 
Ambu, Glen Burnie, MD 
 
 
 
 
 
 
 
 
         Department of Anesthesiology & Perioperative Medicine 
                                     University of Louisville 
 
 
 
                                      Version 3 (6/27/2014) 
                                                  (copyright) 
                            
 
 

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Table of Contents 
 
1.0 
Introduction 
1.1 
Study Conduct 
1.2 
Background 
1.3 
Medical Device 
2.0 
Study Objectives 
3.0 
Study Design  
3.1 
General Design 
3.2 
Primary Study Endpoints 
4.0 
Subject Selection and Withdrawal 
4.1 
General Characteristics of the Proposed Subject Population 
4.2 
Inclusion Criteria 
4.3 
Exclusion Criteria 
4.4 
Subject Recruitment and Screening 
4.5 
Early Withdrawal of Subjects 
4.5.1 Criteria for removal from study 
4.5.2 Follow-up for Withdrawn Subjects 
5.0 
Procedures 
5.1 
Subject management 
5.2 
Bronchoscopy 
5.3 
Measurements 
6.0 
Statistical Plan 
6.1 
Sample Size Determination 
6.2 
Statistical Methods 
6.3 
Subject Population(s) for Analysis 
6.4 
Interim analysis 
7.0 
Risk Analysis 
7.1 
Anticipated Risks 
7.2 
Adverse Event Definitions 
7.3 
Recording of Adverse Events 
7.4 
Causality and Severity Assessment 
7.5 
Reporting of Adverse Effects and Unanticipated Problems 
8.0 
Data Handling and Record Keeping 
8.1 
Confidentiality 
8.2 
Source Documents 
8.3 
Case Report Forms 
8.4 
Record Retention 
8.5 
IRB Documentation 
9.0 
Study Monitoring, Auditing and Inspecting 
9.1 
Study Monitoring Plan 
9.1.1 Study Staff Responsibilities and Training 

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9.1.2 Quality Assurance and Quality Control 
9.1.3 Safety Monitoring 
9.1.4 Monitoring Activities 
9.1.5 Study Closure 
9.2 
Auditing and Inspecting 
10.0 
Ethical Considerations 
10.1 
Institutional Review Board (IRB) Approval 
10.2 
Ethical and Scientific Conduct of the Clinical Research Study 
10.3 
Subject Informed Consent 
11.0 
References 
 
 
 
 
 
 
 
1.0 Introduction 
 
1.1 Study Conduct 
 
This study will be conducted in compliance with the protocol approved by the University 
of Louisville Institutional Review Board, and according to Good Clinical Practice 
standards. No deviation from the protocol will be implemented without the prior review 
and approval of the U of L IRB except where it may be necessary to eliminate an 
immediate hazard to a research subject. In such a case, the deviation will be reported to 
the IRB according to its policies and procedures. 
 
1.2 Background 
 
Flexible bronchoscopy is a frequently performed procedure in the critical care 
unit(Lucena et al., 2012) as well as in an outpatient setting. The procedure is used for 
diagnostic and therapeutic purposes in the diseased lung (Rand et al., 2013). One of the 
main indications for flexible bronchoscopy in the critical care unit is the diagnosis of 
pulmonary infections in the presence of pulmonary infiltrates and or worsening 
pulmonary gas exchange. Flexible bronchoscopy allows to conduct a broncho-alveolar 
lavage (BAL) to both collect specimen for culture, for evidence of alveolar inflammation 
(Perkins, Chatterjie, McAuley, Gao, & Thickett, 2006) and to clean the patient’s 
bronchial tree from mucus and secretions. (Kreider & Lipson, 2003) The latter represents 
the therapeutic part of the procedure. By freeing the bronchi from obstructing secretions 
better aeration will ensue with subsequent resolution of atelectasis and improvement of 
alveolar gas exchange. (Haenel, Moore, Moore, & Read, 1992; Tsao, Tsai, Lan, Shieh, & 
Lee, 1990) Less frequent indications for flexible bronchoscopy in the critical care setting 
are pulmonary hemorrhage, difficult airway management and percutaneous tracheostomy. 
(Estella, 2012) 
Flexible bronchoscopy is an effective and a safe diagnostic and therapeutic procedure in 
the critical care setting. (Bellomo, Tai, & Parkin, 1992). It is typically well tolerated by 

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the patient with respiratory compromise including patients with adult respiratory distress 
syndrome. (Steinberg et al., 1993) In a recent prospective multicenter study more than 
20,986 bronchoscopies were included to evaluate the incidence of complication. The 
study showed that bronchoscopy is associated with a very low incidence of mortality 
(0.02%) and complications (1%). (Facciolongo et al., 2009) 
 
Since the first flexible bronchoscope was introduced by Ikeda in 1968(Ikeda, Yanai, & 
Ishikawa, 1968), the technology has been improved steadily. Development of a better 
image clarity and ease of use has made flexible bronchoscopy a widespread tool in the 
critical care environment.  
 
Flexible bronchoscopes are typically reusable and therefore need high-level disinfection 
to prevent inadvertent spread of microbial pathogens from patient to patient. The process 
of disinfection is time consuming and expensive. Moreover, a bronchoscope being 
processed may not be readily available for another patient. One solution to this problem 
was to use a single-use disposable sheath that covers a flexible bronchoscope protecting 
all surfaces of the bronchoscope. (Colt, Beamis, Harrell, & Mathur, 2000). Another way 
to eliminate potential hazards with a reusable bronchoscope is the use of a disposable 
bronchoscope. Such a disposable bronchoscope has been developed (Ambu aScope, 
Ambu, Glen Burnie, MD) and has been used successfully for intubations in manikins 
(Scutt et al., 2011) and patients. (Kristensen & Fredensborg, 2013; Pujol, López, & 
Valero, 2010; Tvede, Kristensen, & Nyhus-Andreasen, 2012). Further advancement in 
the imaging and handling of this disposable flexible bronchoscope now allows for the 
purpose of bronchoscopy and broncho-alveolar lavage in critically ill patients with 
pulmonary compromise. (FDA approval: 05-11-2013 date) 
 
The aim of the study is to compare image clarity, suction capacity, and handling 
performance of a reusable flexible bronchoscope to the disposable flexible bronchoscope. 
In addition, we intend to perform a cost analysis. 
 
 
1.3 Medical Device 
 
1.3.1 Name of Study Device: aScope3 
 
Technical product specifications 
The device has 2 main components, the scope and the monitor (aView). Sections below 
are a schematic representation of the scope and the aView monitor.   
  
  
  
 
 
 
  
 
  

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Intended Use of the Investigational Device  
 
1.2. Intended use 
 
The aScope 3 endoscopes have been designed to be used with the aView monitor, 
endotherapy accessories and other ancillary equipment for endoscopy 
within the airways and tracheobronchial tree. 

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1.3.2 The Device is based on a new technology that features single-use bronchoscopy. 
  
2.0 Study Objectives 
 
Our goal is to determine whether aScope 3 (Ambu, Glen Burnie, MD) delivers an 
adequate image, suction quality, and has a comparable handling performance compared 
with a standard re-usable bronchoscope (Storz 8402 2x, El Segundo, CA) in the critical-
care setting.  
 
 
3.0 Study Design 
  
3.1 General Design 
 
We propose a prospective, randomized, controlled, crossover study with the plan to enroll 
40 subjects in the critical care unit who have the need for a diagnostic and or therapeutic 
bronchoscopy.  
 
3.2  Study Endpoints 
 
Test the hypothesis that there is no significant difference in performance between the 
single-use, disposable bronchoscope and the non-disposable bronchoscope. The primary 
endpoints will be visualization and handling of the two bronchoscopes. Secondary 
endpoints will be measured suction time and the quality of BAL samples. 
 
4.0 Subject Selection and Withdrawal 
 
4.1 General Characteristics of the Proposed Subject Population 
 
       Adult patients 18 and older who are intubated and have an indication for diagnostic and 
or therapeutic bronchoscopy will be enrolled into the study after patient or patient’s legal 
representative will accept and sign U of L IRB approved Inform Consent Form. We will 
accept patients from all minority groups. Based on the population of greater Louisville, 
we expect that 85% of the subjects will be Caucasian. We will include male and female 
patients in the study.  
 
4.2 Inclusion Criteria 
 
1) Adult 18 years old and older 
2) Capable of giving informed consent or have an acceptable surrogate capable of 
giving legally authorized consent on the subject’s behalf.  
3) Indication of a diagnostic and or therapeutic bronchoscopy as determined by the 
attending critical care physician 
4) Being cared for in the critical care units at the U of L Hospital  
 

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4.3 Exclusion Criteria 
 
1) Patient is moribund and a bronchoscopy is very unlikely to reduce impending 
mortality or can avert death 
 
4.4 Subject Recruitment and Screening 
 
Subjects will be recruited in critical care Units of the University of Louisville 
Hospital. The potential complications will be explained to the patient or his/her legal 
representative twice. First, the patient will have the information presented to them as 
part of the conventional care consents during their stay in the critical care unit. 
Second, the patient will have the information presented again when the investigators 
have a consenting discussion with the potential subjects about the research protocol. 
 
4.5 Early Withdrawal of Subjects 
 
4.5.1 Criteria for Removal from Study 
Subject or his/her legal representative consent withdrawal will be a reason for 
early removal from the study.  
 
4.5.2 Follow-up for Withdrawn Subjects 
There is no follow-up in the study.  
 
5.0 Procedures 
 
5.1 Subject management  
 
Patients will be monitored by standard NIBP or invasive arterial lines, ECG and oxygen 
saturation. All patients are intubated due to their respiratory insufficiency or for airway 
protection. Patients will be anesthetized for the procedure in the ICU. Anesthesia will be 
induced with versed 2mg, fentanyl 100 µg and paralyzed with 0.1mg/kg vecuronium. 
Anesthesia will be maintained with propofol infusion 50-150 µg/kg/min. 
 
All patients will be under general anesthesia as is routine for this clinical procedure. 
Standard monitoring will be applied. This includes a blood pressure cuff or an arterial 
line, EKG and a pulse-oximeter. Patients will receive 2 mg/kg propofol, 1µg/kg fentanyl 
and 0.1mg/kg vecuronium for the procedure. After induction of anesthesia the FiO2 will 
be turned to 1.0 and a bronchoscopy adaptor will be interposed in the breathing circuit 
next to the endotracheal tube.  
 
5.2 Bronchoscopy  
 
Patients will be randomized to receiving either the non-disposable bronchoscope (Storz 
8402 2x, El Segundo, CA) or the single use aScope 3 first. After randomization, 
bronchoscopy will be started with an inspection of the trachea and carina. Next the right 
lung bronchial tree will be inspected systematically beginning with the right upper lobe, 

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following with the right middle lobe and finishing with the right lower lobe. All 
segmental bronchi will be inspected and cleaned by suction as deemed necessary. The 
bronchoscope will then be removed from the bronchial tree and rinsed with saline 
Subsequently, the bronchoscope will be re-inserted and advanced to the basal segmental 
bronchi of the right lower lobe. The tip of the bronchoscope will be brought into wedge 
position in one of the basal segments for broncho-alveolar lavage (BAL). A saline flush 
of 20 ml will be administered. The flow of saline will be observed at the distal tip of the 
bronchoscope. After 10 seconds of maintaining a wedge position, gentle suction will be 
applied to collect the lavage specimen in the collection trap. This step will be repeated 4 
more times (total of 80ml) to obtain an adequate specimen. The same procedure will be 
repeated on the left lung using the alternate bronchoscope according to randomization. 
At the end of the procedure, a chest radiograph will be obtained to rule out 
pneumothorax. 
 
5.3 Measurements 
 
Before starting the procedure the set up time of each bronchoscope will be recorded. The 
view, image, and light of each bronchoscope will be assessed, then the inspection of the 
upper lobe segmental bronchi will be conducted. The time of lavage and suctioning until 
no more specimen can be collected will be measured. The volume of the obtained 
specimen will be measured. The specimen will be evaluated by a blinded observer after 
the procedure is completed. (clear fluids, mucous secretions, viscous secretions, pus, 
blood etc). The blinded observer will evaluate the quality and quantity of the sample for 
obtaining cultures. The blinded observer will be an attending or resident from the 
anesthesiology or infectious diseases department.     
 
The overall ease of handling will be rated directly after the procedure by the investigator. 
All bronchoscopies will be taped and view-clarity, image and light-brightness will be 
assessed by a second blinded observer. This blinded observer can be another investigator 
not present during the procedure or an internist who was not present and is part of the 
study team. 
 
 All assessments will be performed using a qualitative scale as 1excellent, 2 good, 3 fair 
or 4 poor and 5 cannot be evaluated.  
 
  
6.0 Statistical Plan 
 
6.1 Sample Size Determination 
 
We are planning to enroll 40 patients.  
 
6.2 Statistical Analysis 
 
  All measured times will be compared using paired T-tests. Categorical data will be 
compared using McNemar’s test. All data will be expressed as mean ± SD.  
 

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Any deviations from the previously described statistical plan will be described and 
justified in a protocol amendment and/or in the final report submitted to the IDE 
application. 
 
6.3 Interim Analysis 
 
There is no interim analysis planned. 
 
7.0 Risk Analysis 
 
Bronchoscopy is a well-tolerated procedure. The reported mortality rate is around 0.02% 
(Facciolongo et al., 2009) Adverse events may be transient fever (5%) and chills(Sharif-
Kashani et al., 2010) associated with a non-infective acute inflammatory response with 
absence of bacteremia (Georgiades et al., 2003; Huang, Bassett, Levin, Montilla, & 
Ghio, 2006; Um et al., 2004), and bronchospasm (<1%). Bronchoscopy involves several, 
although rare, risks including mucosal bleeding, development of a pneumothorax with 
the need of insertion of a chest tube. Another risk may be contamination and (cross)-
infection secondary to the insertion of the bronchoscope. In addition, during 
bronchoscopy there may be a transient decrease in baseline PaO2 and oxygen saturation 
may drop to a level below 90%. In this case, bronchoscopy will be interrupted to allow 
the patient’s lungs to recover. Occasionally, the procedure may have to be aborted. At 
the end of the procedure, a chest radiograph will be obtained to rule out pneumothorax. 
The only difference to routine bronchoscopy is that we will use two different 
bronchoscopes, one on each side of the lung, as compared to one non-disposable 
bronchoscope during routine bronchoscopy.  
 
The proposed study will be conducted with approval of the Human Studies Committees 
at the University of Louisville. The investigators must receive written, informed consent 
from participating patients or authorized representatives. The principal investigator and 
all collaborators have completed an IRB-certified human subject protection-training 
course. 
 
We will only enroll patients who were admitted to a critical care unit at the University of 
Louisville and who are intubated.  
 
7.1 Anticipated Risks  
 
The potential complications will be explained to the patient or his/her legal representative 
twice. First, the patient will have the information presented to them as part of the 
conventional care consents during their stay in the critical care unit. Second, the patient 
will have the information presented again when the investigators have a consenting 
discussion with the potential subjects about the research protocol and anticipated risks. 
 
Possible risk associated with bronchoscopy may include but is not limited to the 
following: 
•  Transient hypotension related to sedation (low blood pressure) 
• Bronchospasm (spasm of the large passageways in the lung) 

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• Hypoxemia (decrease in oxygen) 
• Bleeding 
• Pneumothorax (collection of air inside the chest around the lungs which leads 
to lung collapse) 
• Cardiac arrhythmias (irregular heartbeats) 
7.2 Adverse Event Definitions 
 
Adverse effect. Any untoward medical occurrence in a clinical study of an study device; 
regardless of the causal relationship of the problem with the device or, if applicable, other 
study treatment or diagnostic product(s). 
 
Associated with the study device.  There is a reasonable possibility that the adverse effect 
may have been caused by the investigational device or, if applicable, the other study 
treatment or diagnostic product(s). 
 
Disability.  A substantial disruption of a person’s ability to conduct normal life functions. 
 
Life-threatening adverse effect.  Any adverse effect that places the subject, in the view of 
the investigator-sponsor, at immediate risk of death from the effect as it occurred (i.e., 
does not include an adverse effect that, had it actually occurred in a more severe form, 
might have caused death). 
 
Serious adverse effect. Any adverse effect that results in any of the following outcomes: 
death, a life-threatening adverse effect, inpatient hospitalization or prolongation of 
existing hospitalization, a persistent or significant disability/incapacity, or a congenital 
anomaly/birth defect. 
 
• Hospitalization shall include any initial admission (even if less than 24 hours) 
to a healthcare facility as a result of a precipitating clinical adverse effect; to 
include transfer within the hospital to an intensive care unit.  Hospitalization 
or prolongation of hospitalization in the absence of a precipitating, clinical 
adverse effect (e.g., for a preexisting condition not associated with a new 
adverse effect or with a worsening of the preexisting condition; admission for 
a protocol-specified procedure) is not, in itself, a serious adverse effect. 
 
Unexpected adverse effect.  Any adverse effect, the frequency, specificity or severity of 
which is not consistent with the risk information described in the clinical study 
protocol(s). 
 
Unanticipated adverse device effect.  Any serious adverse effect on health or safety or 
any life-threatening problem or death caused by, or associated with, a device, if that 
effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the protocol, or any other unanticipated serious problem associated with a 
study device that relates to the rights, safety, or welfare of subjects. 
 
7.3 Recording of Adverse Events 
 

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All observed or volunteered adverse effects (serious or non-serious) findings, or 
suspected causal relationship to the study device will be recorded in the subjects’ case 
histories.  For all adverse effects, sufficient information will be pursued and/or obtained 
so as to permit 1) an adequate determination of the outcome of the effect (i.e. , whether 
the effect should be classified as serious adverse effect) and; 2)  an assessment of the 
casual relationship between the adverse effect and the study protocol.    
 
Adverse effects felt to be associated with the study device will be followed until the 
effect (or its sequelae) resolves or stabilizes at a level acceptable to the investigator. 
 
7.4 Causality and severity assessment 
 
The investigator will promptly review documented adverse effects and abnormal test 
findings to determine 1) if there is a reasonable possibility that the adverse effect was 
caused by the study protocol or device; and 2) if the adverse effect meets the criteria for a 
serious adverse effect. 
 
If the investigator’s final determination of causality is “unknown and of questionable 
relationship to the study device/protocol, the adverse effect will be classified as 
associated with the use of the study device for reporting purposes.  If the investigator’s 
final determination of causality is “unknown but not related to the study protocol/device 
this determination and the rationale for the determination will be documented in the 
respective subject’s case history. 
 
7.5 Reporting of Adverse Effects and Unanticipated Problems 
 
In accordance with applicable policies of the UofL Institutional Review Board (IRB), the 
investigator will report, to the IRB, any observed or volunteered adverse effect that is 
determined to be (1) unexpected; (2) related or possibly related to the research; and (3) 
involves increased or greater risk of harm to participant(s) or others than was previously 
known or approved by the UofL IRB. Adverse effect reports will be submitted to the 
UofL IRB in accordance with the UofL IRB policies and procedures.  
 
8.0 Data Handling and Record Keeping 
 
8.1 Confidentiality 
 
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 
(HIPAA).  Consistent with these regulations a signed authorization will be obtained that 
informs each subject of the following:   
• 
What protected health information (PHI) will be collected from subjects in 
this study 
•  Who will have access to that information and why 
•  Who will use or disclose that information 
• 
The rights of a research subject to revoke their authorization for use of 
their PHI.  

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In the event that a subject revokes authorization to collect or use PHI, the investigator, 
by regulation, retains the ability to use all information collected prior to the revocation 
of subject authorization.  For subjects that have revoked authorization to collect or use 
PHI, attempts should be made to obtain permission to collect at least vital status (i.e. 
that the subject is alive) at the end of their scheduled study period. 
 
8.2 Source Documents 
 
Study coordinators and research fellows are responsible for data collection. 
Source data are all information, original records of clinical findings, observations, or 
other activities in a clinical trial necessary for the reconstruction and evaluation of the 
trial.  Source data are contained in source documents.   
 
8.3 Case Report Forms 
 
Coordinators and PI are responsible for case report forms. PI will review the CRFs for 
accuracy and completion on an ongoing basis throughout the study.  
The study case report form (CRF) is the primary data collection instrument for the 
study.  All data requested on the CRF must be recorded.  All missing data must be 
explained.  If a space on the CRF is left blank because the procedure was not done or 
the question was not asked, write “N/D”.  If the item is not applicable to the individual 
case, write “N/A”.   
 
8.4 Record Retention 
 
It is the investigator’s responsibility to retain study essential documents during the 
investigation and for a period of 2 years after the date on which the investigation is 
terminated or completed.  
 
Research records and original signed consent forms are to be retained by the principal 
investigator for at least 6 years if the form includes authorization for use of private 
health information. The 6-year minimum retention of authorizations complies with the 
privacy regulation requirements. 
 
8.5 IRB Documentation 
 
Regulatory coordinator is responsible for maintaining IRB Correspondence. All UofL 
IRB approved documents will be maintained as part of the study. 
 
9.0 Study Monitoring, Auditing and Inspecting 
 
    9.1 Study Staff Responsibilities and Training. 
                  CITI Training 
The investigators and all staff involved in the study will have completed their required 
U of L Research training.  
 

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Protocol Procedure Training 
Study staff delegated to conduct specific study procedures will be trained on these 
procedures individually or in a group format.  A record of this training will be kept on 
the study-training log. 
 
9.2 Safety Monitoring 
 
The research coordinator will complete the appropriate report form and logs; assist 
the PI to prepare reports and notify the IRB of all Unanticipated Problems/SAE’s. 
 
The research coordinator and Principal Investigator will confirm that all Adverse 
effects (AE) are correctly entered into the AE log by the coordinator; be available to 
answer any questions that the coordinators may have concerning AEs; notify the IRB of 
all Unanticipated Problems/SAEs and AEs as appropriate. All assessments of AEs will 
be made by a licensed medical professional who is an investigator on the research. 
 
9.3 Auditing and Inspecting 
 
 
The investigator will permit study-related monitoring, audits, and inspections by the 
Research Quality Assurance Office, UofL IRB, and government regulatory bodies, of 
all study related documents (e.g. source documents, regulatory documents, data 
collection instruments, study data etc.).  The investigator will ensure the capability for 
inspections of applicable study-related facilities.        
 
 
10.0 Ethics 
 
This study will be conducted in compliance with the protocol approved by the 
University of Louisville Institutional Review Board, the relevant federal regulations, 
and IRB policies and procedures and according to Good Clinical Practice standards. No 
deviation from the protocol will be implemented without the prior review and approval 
of the IRB except where it may be necessary to eliminate an immediate hazard to a 
research subject. In such a case, the deviation will be reported to the IRB according to 
its policies and procedures. 
 
All subjects for this study will be provided a consent form describing this study and 
providing sufficient information for subjects/LARs to make an informed decision about 
their participation in this study.  This consent form will be submitted with the protocol 
for review and approval by the IRB for the study.  The formal consent of all subjects 
will be sought using the IRB-approved consent form. Before a subject undergoes any 
study procedure, an informed consent discussion will be conducted and written 
informed consent obtained with a consent form signed by the subject or legally 
acceptable surrogate if applicable. An investigator-designated research professional will 
obtain written informed consent from subjects. 
 
 
11.0 References: 
 

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Bellomo, R., Tai, E., & Parkin, G. (1992). Fibreoptic bronchoscopy in the critically ill: 
a prospective study of its diagnostic and therapeutic value. Anaesth Intensive Care, 
20(4), 464–469. 
Colt, H. G., Beamis, J. J., Harrell, J. H., & Mathur, P. M. (2000). Novel flexible 
bronchoscope and single-use disposable-sheath endoscope system. A preliminary 
technology evaluation. Chest, 118(1), 183–187. 
Estella, A. (2012). [Analysis of 208 flexible bronchoscopies performed in an intensive 
care unit]. Medicina intensiva / Sociedad Espanola de Medicina Intensiva y Unidades 
Coronarias, 36(6), 396–401. doi:10.1016/j.medin.2011.11.005 
Facciolongo, N., Patelli, M., Gasparini, S., Lazzari Agli, L., Salio, M., Simonassi, C., et 
al. (2009). Incidence of complications in bronchoscopy. Multicentre prospective study 
of 20,986 bronchoscopies. Monaldi archives for chest disease = Archivio Monaldi per 
le malattie del torace / Fondazione clinica del lavoro, IRCCS [and] Istituto di clinica 
tisiologica e malattie apparato respiratorio, Università di Napoli, Secondo ateneo, 
71(1), 8–14. 
Georgiades, G., Myrianthefs, P., Venetsanou, K., Kythreoti, A., Kyroudi, A., Kittas, C., 
& Baltopoulos, G. (2003). Temperature and serum proinflammatory cytokine changes 
in patients with NSCLC after BAL. Lung, 181(1), 35–47. doi:10.1007/s00408-003-
1001-6 
Haenel, J. B., Moore, F. A., Moore, E. E., & Read, R. A. (1992). Efficacy of selective 
intrabronchial air insufflation in acute lobar collapse. American journal of surgery, 
164(5), 501–505. 
Huang, Y.-C. T., Bassett, M. A., Levin, D., Montilla, T., & Ghio, A. J. (2006). Acute 
phase reaction in healthy volunteers after bronchoscopy with lavage. Chest, 129(6), 
1565–1569. doi:10.1378/chest.129.6.1565 
Ikeda, S., Yanai, N., & Ishikawa, S. (1968). Flexible bronchofiberscope. The Keio 
journal of medicine, 17(1), 1–16. 
Kreider, M. E., & Lipson, D. A. (2003). Bronchoscopy for atelectasis in the ICU: a case 
report and review of the literature. Chest, 124(1), 344–350. 
Kristensen, M. S., & Fredensborg, B. B. (2013). The disposable Ambu aScope vs. a 
conventional flexible videoscope for awake intubation -- a randomised study. ACTA 
ANAESTHESIOLOGICA SCANDINAVICA, 57(7), 888–895. doi:10.1111/aas.12094 
Lucena, C. M., Martínez-Olondris, P., Badia, J. R., Xaubet, A., Ferrer, M., Torres, A., 
& Agustí, C. (2012). [Fiberoptic bronchoscopy in a respiratory intensive care unit]. 
Medicina intensiva / Sociedad Espanola de Medicina Intensiva y Unidades Coronarias, 
36(6), 389–395. doi:10.1016/j.medin.2011.11.004 
Perkins, G. D., Chatterjie, S., McAuley, D. F., Gao, F., & Thickett, D. R. (2006). Role 
of nonbronchoscopic lavage for investigating alveolar inflammation and permeability in 
acute respiratory distress syndrome. Critical care medicine, 34(1), 57–64. 
Pujol, E., López, A. M., & Valero, R. (2010). Use of the Ambu(®) aScope™ in 10 
patients with predicted difficult intubation. Anaesthesia, 65(10), 1037–1040. 
doi:10.1111/j.1365-2044.2010.06477.x 
Rand, Du, I. A., Blaikley, J., Booton, R., Chaudhuri, N., Gupta, V., Khalid, S., et al. 
(2013, August). British Thoracic Society guideline for diagnostic flexible bronchoscopy 
in adults: accredited by NICE. Thorax. doi:10.1136/thoraxjnl-2013-203618 
Scutt, S., Clark, N., Cook, T. M., Smith, C., Christmas, T., Coppel, L., & Crewdson, K. 

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(2011). Evaluation of a single-use intubating videoscope (Ambu aScope ™) in three 
airway training manikins for oral intubation, nasal intubation and intubation via three 
supraglottic airway devices. Anaesthesia, 66(4), 293–299. doi:10.1111/j.1365-
2044.2011.06647.x 
Sharif-Kashani, B., Shahabi, P., Behzadnia, N., Mohammad-Taheri, Z., Mansouri, D., 
Masjedi, M. R., et al. (2010). Incidence of fever and bacteriemia following flexible 
fiberoptic bronchoscopy: a prospective study. Acta medica Iranica, 48(6), 385–388. 
Steinberg, K. P., Mitchell, D. R., Maunder, R. J., Milberg, J. A., Whitcomb, M. E., & 
Hudson, L. D. (1993). Safety of bronchoalveolar lavage in patients with adult 
respiratory distress syndrome. The American review of respiratory disease, 148(3), 
556–561. doi:10.1164/ajrccm/148.3.556 
Tsao, T. C., Tsai, Y. H., Lan, R. S., Shieh, W. B., & Lee, C. H. (1990). Treatment for 
collapsed lung in critically ill patients. Selective intrabronchial air insufflation using the 
fiberoptic bronchoscope. Chest, 97(2), 435–438. 
Tvede, M. F., Kristensen, M. S., & Nyhus-Andreasen, M. (2012). A cost analysis of 
reusable and disposable flexible optical scopes for intubation. ACTA 
ANAESTHESIOLOGICA SCANDINAVICA, 56(5), 577–584. doi:10.1111/j.1399-
6576.2012.02653.x 
Um, S.-W., Choi, C.-M., Lee, C.-T., Kim, Y. W., Han, S. K., Shim, Y.-S., & Yoo, C.-
G. (2004). Prospective analysis of clinical characteristics and risk factors of 
postbronchoscopy fever. Chest, 125(3), 945–952.