Reusable Flexible Bronchoscopes Versus Single Use Bronchoscopes : a Satisfaction Survey

Reusable (RU) flexible bronchoscopes (FB) require intermediate level disinfection operations to prevent transmission of infectious agents from patient to patient. These operations have a significant material and human cost and impact their availability in case of emergency. One alternative is the use of disposable FB.

The aim of the study is to evaluate the quality of FB during procedures carried out with each of the two solutions in intensive care unit (ICU), respiratory endoscopy (RE) and anesthesia (A) department.

A prospective non-interventional and non-randomized monocentric study compare the operator satisfaction of therapeutic procedures performed with RU FB (EB FujifilmTM range, FB/FI PentaxMedicalTM range, StorzTM intubation FB) versus disposable FB (aScope 3® and aScope 4® (AmbuTM), Broncoflex® (AxessvisionTM). An evaluation form is completed by the operator at the end of procedure. Judging criteria, rated from 0 to 10, concern handling, ergonomics, image and suction quality.

Study Overview

• Status: Unknown
• Conditions: Bronchoscope Users

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Valentin David; Phone Number: +33618500489; Email: valentin.david@chu-limoges.fr
• Study Contact Backup: Name: Thomas DAIX; Phone Number: +33555054082; Email: thomas.daix@chu-limoges.fr

Study Locations

• France
  • Limoges, France, 87042
    • Recruiting
    • University Hospital, Limoges
    • Contact: Thomas Daix
    • Contact: valentin david

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent therapeutic bronchoscopy in anesthesia department, respiratory endoscopy unit, and critical care unit

Description

Inclusion Criteria:

• Patients who underwent a therapeutic bronchoscopy (Bronchoalveolar lavage, protected bronchial brushing, suction, difficult intubation)
• Patient followed or treated at the Limoges University Hospital

Exclusion Criteria:

• Patient < 18 years
• Diagnostic bronchoscopy
• Interventional bronchoscopy

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Bronchial endoscopy; Compare quality procedures performed with reusable versus disposable bronchoscopes in respiratory endoscopy unit
Critical care unit; Compare quality procedures performed with reusable versus disposable bronchoscopes in critical care unit
Anesthesia department; Compare quality procedures performed with reusable versus disposable bronchoscopes in anesthesia department

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bronchoscopes overall reliability: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent	Time required to carry out the bronchoscopy (between 5 and 15 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Passage of the endoscope through the probe (intubated patient): comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: very difficult 4/10: difficult 6/10: relatively easy 8/10: easy 10/10: very easy	time required to carry out the bronchoscopy (between 5 and 15 minutes)
Bronchoscope access to trachea (non-intubated patient): comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: very difficult 4/10: difficult 6/10: relatively easy 8/10: easy 10/10: very easy	time required to carry out the bronchoscopy (between 5 and 15 minutes)
Bronchial catheterization: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable	A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: very difficult 4/10: difficult 6/10: relatively easy 8/10: easy 10/10: very easy	time required to carry out the bronchoscopy (between 5 and 15 minutes)
Left/right rotation of the insertion tube: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent	time required to carry out the bronchoscopy (between 5 and 15 minutes)
Crutch handling: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent	time required to carry out the bronchoscopy (between 5 and 15 minutes)
Close brightness: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent	time required to carry out the bronchoscopy (between 5 and 15 minutes)
Outer brightness: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent	time required to carry out the bronchoscopy (between 5 and 15 minutes)
Close focus: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent	time required to carry out the bronchoscopy (between 5 and 15 minutes)
Close sharpness: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable	A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent	time required to carry out the bronchoscopy (between 5 and 15 minutes)
Outer sharpness: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent	time required to carry out the bronchoscopy (between 5 and 15 minutes)
Color reproduction: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent	time required to carry out the bronchoscopy (between 5 and 15 minutes)
Image contrast: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent	time required to carry out the bronchoscopy (between 5 and 15 minutes)
Image size: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent	time required to carry out the bronchoscopy (between 5 and 15 minutes)
Reproduction of anatomic reality: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent	time required to carry out the bronchoscopy (between 5 and 15 minutes)
Suction quality: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent	time required to carry out the bronchoscopy (between 5 and 15 minutes)

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): December 30, 2018
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 8, 2018

Study Record Updates

• Last Update Posted (Actual): July 9, 2018
• Last Update Submitted That Met QC Criteria: July 5, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Intratracheal intubation, bronchoscopy, bronchoalveolar lavage, endoscopy, pulmonary medicine, critical care, anesthesia department, disinfection
• Other Study ID Numbers: I17023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No