Bronchoscope UsersNCT03392610
Reusable Flexible Bronchoscopes Versus Single Use Bronchoscopes : a Satisfaction Survey
An observational study of Bronchoscope Users, run by University Hospital, Limoges at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchoscope Users
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2017to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent therapeutic bronchoscopy in anesthesia department, respiratory endoscopy unit, and critical care unit
Who may be able to join
- Patients who underwent a therapeutic bronchoscopy (Bronchoalveolar lavage, protected bronchial brushing, suction, difficult intubation)
- Patient followed or treated at the Limoges University Hospital
Who cannot join
- Patient < 18 years
- Diagnostic bronchoscopy
- Interventional bronchoscopy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University hospital, Limoges
Limoges, 87042
valentin david
thomas daix
About this study
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.
- Conditions
- Bronchoscope Users
- Keywords
- Intratracheal intubation, bronchoscopy, bronchoalveolar lavage, endoscopy, pulmonary medicine, critical care, anesthesia department, disinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time required to carry out the bronchoscopy (between 5 and 15 minutes)
Secondary outcomes (15)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: time required to carry out the bronchoscopy (between 5 and 15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start1 Oct 2017
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchoscope UsersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392610
- Sponsor's protocol ID
- I17023
- Status last verified
- Oct 2017
- First submitted
- 6 Dec 2017
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reusable Flexible Bronchoscopes Versus Single Use Bronchoscopes : a Satisfaction Survey
- ClinicalTrials.gov ID
- NCT03392610
- Acronym / sponsor ID
- I17023
- Conditions
- Bronchoscope Users
- Keywords
- Intratracheal intubation, bronchoscopy, bronchoalveolar lavage, endoscopy, pulmonary medicine, critical care, anesthesia department, disinfection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent therapeutic bronchoscopy in anesthesia department, respiratory endoscopy unit, and critical care unit
Key inclusion criteria (2 listed)
- Patients who underwent a therapeutic bronchoscopy (Bronchoalveolar lavage, protected bronchial brushing, suction, difficult intubation)
- Patient followed or treated at the Limoges University Hospital
Key exclusion criteria (3 listed)
- Patient < 18 years
- Diagnostic bronchoscopy
- Interventional bronchoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bronchoscopes overall reliability: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB
Time frame: Time required to carry out the bronchoscopy (between 5 and 15 minutes)
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
15 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: time required to carry out the bronchoscopy (between 5 and 15 minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchoscope Users, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valentin David (+33618500489, valentin.david@chu-limoges.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchoscopes overall reliability: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB (time frame: Time required to carry out the bronchoscopy (between 5 and 15 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2018.