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Evaluation of a Disposable Flexible Bronchoscope, aScope IV

NCT02255838 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-04-26

Study results available
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Summary

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.

Conditions

  • Respiratory Insufficiency
  • Pneumonia
  • Atelectasis

Interventions

DEVICE

Bronchoscope reusable (Storz 8402 2x)

Bronchoscopy and alveolar lavage

DEVICE

Bronchoscope disposable (aScope 4)

Bronchoscopy and alveolar lavage

Sponsors & Collaborators

  • University of Louisville

    lead OTHER

Principal Investigators

  • Rainer Lenhardt, MD MBA · University of Louisville School of Medicine Department of Anesthesiology and Perioperative Medicine

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-01
Primary Completion
2020-01-14
Completion
2020-01-14

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02255838 on ClinicalTrials.gov