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

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ClinicalTrials.gov Identifier: NCT02255838
Recruitment Status : Suspended (scope has a new modification with an improved view that will be used when available.)
First Posted : October 3, 2014
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
Rainer Lenhardt, University of Louisville

September 24, 2014
October 3, 2014
February 16, 2018
April 2015
April 2020   (Final data collection date for primary outcome measure)
  • Evaluation of visualization between two different flexible bronchoscopes, a disposable and a reusable bronchoscope [ Time Frame: one year ]
    Visualization of the two bronchoscopes using a qualitative scale
  • Evaluation of the handling of two different flexible bronchoscopes, a disposable and a reusable bronchoscope [ Time Frame: one year ]
    Handling of the two bronchoscopes using a qualitative scale
  • Evaluation of two different flexible bronchoscopes, a disposable and a reusable bronchoscope [ Time Frame: one year ]
    Visualization of the two bronchoscopes using a qualitative scale
  • Evaluation of two different flexible bronchoscopes, a disposable and a reusable bronchoscope [ Time Frame: one year ]
    Handling of the two bronchoscopes using a qualitative scale
Complete list of historical versions of study NCT02255838 on ClinicalTrials.gov Archive Site
  • Evaluation of ability to suction adequatly of two different flexible bronchoscopes, a disposable and a reusable bronchoscope [ Time Frame: one year ]
    Measured suction time in seconds using a qualitative scale
  • Evaluation of BAL results between two different flexible bronchoscopes, a disposable and a reusable bronchoscope [ Time Frame: one year ]
    Quality of BAL samples using a qualitative scale
  • Evaluation of two different flexible bronchoscopes, a disposable and a reusable bronchoscope [ Time Frame: one year ]
    Measured suction time in seconds using a qualitative scale
  • Evaluation of two different flexible bronchoscopes, a disposable and a reusable bronchoscope [ Time Frame: one year ]
    Quality of BAL samples using a qualitative scale
Not Provided
Not Provided
 
Evaluation of a Disposable Flexible Bronchoscope, aScope III
Evaluation of a Disposable Flexible Bronchoscope, (aScope III) 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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
The disposable aScope III bronchoscope will be compared to the re-usable bronchoscope
Masking: None (Open Label)
Masking Description:
A blinded investigator will view the bronchoscopy video and evaluate. The blinded investigator will use the same criteria the investigator who did the procedure used (Un-blinded) for the evaluation. Video will not indicate which scope was used and only indicate if it is the right or left lung they are viewing. Research coordinator will keep separate a file indicating which scope was used.
Primary Purpose: Diagnostic
  • Respiratory Insufficiency
  • Pneumonia
  • Atelectasis
  • Device: Bronchoscope reusable (Storz 8402 2x)
    Bronchoscopy and alveolar lavage
    Other Name: Storz 8402 2x (Storz, El Segundo, CA)
  • Device: Bronchoscope disposable (aScope 3)
    Bronchoscopy and alveolar lavage
    Other Name: aScope 3 (Ambu, Glen Burnie, MD)
  • Experimental: Bronchoscope disposable, aScope III
    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.
    Intervention: Device: Bronchoscope disposable (aScope 3)
  • Active Comparator: Bronchoscope reusable 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.
    Intervention: Device: Bronchoscope reusable (Storz 8402 2x)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
40
Same as current
December 2020
April 2020   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02255838
14.0689
No
Not Provided
Plan to Share IPD: No
Rainer Lenhardt, University of Louisville
University of Louisville
Not Provided
Principal Investigator: Rainer Lenhardt, MD MBA University of Louisville School of Medicine Department of Anesthesiology and Perioperative Medicine
University of Louisville
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP