Reusable Flexible Bronchoscopes Versus Single Use Bronchoscopes : a Satisfaction Survey

NCT ID: NCT03392610

Last Updated: 2018-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bronchoscope Users

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Bronchial endoscopy

Compare quality procedures performed with reusable versus disposable bronchoscopes in respiratory endoscopy unit

No interventions assigned to this group

Critical care unit

Compare quality procedures performed with reusable versus disposable bronchoscopes in critical care unit

No interventions assigned to this group

Anesthesia department

Compare quality procedures performed with reusable versus disposable bronchoscopes in anesthesia department

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University hospital, Limoges

Limoges, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Valentin David

Role: CONTACT

+33618500489

Thomas DAIX

Role: CONTACT

+33555054082

Facility Contacts

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valentin david

Role: primary

thomas daix

Role: backup

Other Identifiers

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I17023

Identifier Type: -

Identifier Source: org_study_id

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