Evaluation of a Disposable Flexible Bronchoscope, aScope IV (EVAL)

April 25, 2022 updated by: Rainer Lenhardt, University of Louisville

Evaluation of a Disposable Flexible Bronchoscope, (aScope IV) a Randomized, Controlled, Cross-over Trial

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, the investigators intend to perform a cost analysis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Description

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. 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.

Study Procedures All patients will be under general anesthesia. 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. 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, 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.

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 quanity of the sample for obtaining cultures.The blinded observer will be an attending or resident from the infectious disease 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 blinder 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 VAS scale of 0 to 10 cm as shown below. The investigator will mark directly on the scale.

We will only enroll patients who were admitted to a critical care unit at the University of Louisville and who are intubated.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

1) Patient is moribund and a bronchoscopy is very unlikely to reduce impending mortality or can avert death

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Disposable bronchoscope first (aScope IV), then Reusable bronchoscope (Storz 8402 2x)
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.
Device: Bronchoscope disposable (aScope 4)
Bronchoscopy and alveolar lavage
Other Names:
  • aScope 4 (Ambu, Glen Burnie, MD)
Active Comparator: Reusable bronchoscope first (Storz 8402 2x), then Disposable bronchoscope (aScope IV)
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.
Device: Bronchoscope reusable (Storz 8402 2x)
Bronchoscopy and alveolar lavage
Other Names:
  • Storz 8402 2x (Storz, El Segundo, CA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Visualization of Two Different Flexible Bronchoscopes; a Disposable and a Reusable Bronchoscope
Time Frame: 10 to 30 minutes
Visualization of the two bronchoscopes was measured by using a qualitative scale from 0 to 10; 0 being classified as "cannot be evaluated" and 10 being assessed as optimal visualization
10 to 30 minutes
Evaluation of the Handling of Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope
Time Frame: 10-30 minutes
Handling of the two bronchoscopes using a qualitative scale from 0 to 10; 0 being classified as "cannot be evaluated" and 10 being assessed as optimal visualization
10-30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Ability to Suction With Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope
Time Frame: 10-30 minutes
Measured suction capability by volume retrieved after broncho-alveolar lavage with 10 ml of saline, measured in ml
10-30 minutes
Evaluation of Flexibility of Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope
Time Frame: 10-30 minutes
Flexibility of the two bronchoscopes was measured by using a qualitative scale from 0 to 10; 0 being classified as "cannot be evaluated" and 10 being assessed as optimal flexibility
10-30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Investigators

  • Principal Investigator: Rainer Lenhardt, MD MBA, University of Louisville School of Medicine Department of Anesthesiology and Perioperative Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

January 14, 2020

Study Completion (Actual)

January 14, 2020

Study Registration Dates

First Submitted

September 24, 2014

First Submitted That Met QC Criteria

September 30, 2014

First Posted (Estimate)

October 3, 2014

Study Record Updates

Last Update Posted (Actual)

April 26, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14.0689

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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