Mechanical Ventilation ComplicationVentSetFibNCT06562725
Ventilator Settings for Bronchoscopy During Mechanical Ventilation: a Randomized Controlled Study
A study testing specific ventilator settings in people with Mechanical Ventilation Complication and Fiberoptic Bronchoscopy, run by Centre Hospitalier Arras at 1 site in France.
Trial summary
Fiberoptic bronchoscopy (FOB) can cause a significant increase in respiratory resistances and airway pressure during mechanical ventilation (MV), which can jeopardize the delivery of the ventilatory assistance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Fiberoptic Bronchoscopy, Critical Illness
- What is being tested?
- specific ventilator settings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 10 Sep 2024to 19 Jun 2025
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥18 years;
- Acute respiratory failure requiring invasive mechanical ventilation in the intensive care unit;
- Indication of either a fiberoptic bronchoscopy (FOB) procedure or a percutaneous tracheostomy under FOB control;
- Patient under sedation with Richmond Agitation and Sedation Scale(RASS) ≤-2,
- Written informed consent obtained by the patient or the patient legal representative
Who cannot join
- Presence of an absolute contraindication to FOB (respiratory arrest, severe acute respiratory distress syndrome (ARDS), refractory shock, uncontrolled heart rhythm disorder);
- Patients in respiratory distress or with severe patient-ventilator desynchronies ;
- Patients refusing FOB;
- Pregnancy ;
- Moribund patients (according to American Society of Anesthesiologists (ASA) Physical status score classification, class 5: high probability of death within 24 hours) or at high risk of death during the FOB procedure;
- Patients deprived of liberty;
- Patients under curators or guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
Fiberoptic bronchoscopy (FOB) can cause a significant increase in respiratory resistances and airway pressure during mechanical ventilation (MV), which can jeopardize the delivery of the ventilatory assistance. This randomized controlled study tests the hypothesis that new ventilator settings aimed at reducing airway pressure may facilitate FOB during MV. Results of this trial should lead to propose a new ventilatory strategy for critically ill patients needing a FOB procedure under MV.
Read the detailed description
Introduction : Fiberoptic bronchoscopy (FOB) during mechanical ventilation (MV) is a challenging procedure as it considerably reduces the endotracheal tube internal diameter, increasing respiratory resistances, which may compromise the delivering of the ventilatory assistance. According to respiratory physiology principles applied to MV, the reduction of inspiratory flow and tidal volume are likely to reduce airway pressure during the inspiratory phase when respiratory resistances increase. Based on this assumption, we propose new ventilator settings aimed at reducing airway pressure during FOB. This study represents the first investigation to test special ventilator settings in order to facilitate FOB during MV.
Methods and analysis : This is a single-center randomized controlled trial, in which intubated patients undergoing a FOB will be assigned (1/1) either to receive the new ventilatory strategy or to stay on the ventilator settings previously selected by the attending physician. The intervention group will be applied the specific ventilator settings (inspiratory flow \<25 L/min, tidal volume = 5 mL/Kg, inspiratory time = 1 sec, respiratory frequency \<20c/min, positive end expiratory pressure(PEEP) = 5 cmH2O). The primary endpoint will be the reduction of the occurrence of a serious adverse event - inability to deliver the ventilatory support, significant arterial desaturation, or hemodynamics instability - during FOB prompting the interruption of the procedure. The sample size was estimated at a minimum of 46 patients to demonstrate a 50% reduction in the occurrence of such a serious adverse event with a power of 90% and an alpha risk of 0.05 (paired Student t-test).
An adjudication committee evaluates images (scope and monitor) to validate primary endpoint. This is done blinding randomization group.
Results of this trial should lead to propose a new ventilatory strategy for critically ill patients needing a FOB procedure under MV.
- Conditions
- Mechanical Ventilation Complication, Fiberoptic Bronchoscopy, Critical Illness, Acute Respiratory Failure
- Being tested
- specific ventilator settings
- Keywords
- Fiberoptic bronchoscopy, Mechanical Ventilation, acute respiratory failure, Tracheostomy
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specific ventilator settingsOther
The special ventilator settings used in the intervention group - aimed at reducing airway pressure - include inspiratory flow <25 L/min, tidal volume = 5m L/Kg, inspiratory time = 1 sec, respiratory frequency <20 c/min, PEEP = 5 cmH2O, and FiO2 = 100%
| Study group | Role | What they receive |
|---|---|---|
| standard ventilator settings | No intervention | Patients randomized in the control group "standard ventilator settings" will be left on the ventilator settings previously chosen by the attending physician, except Inspired Oxygen Fraction(FiO2) increased to 100% |
| specific ventilator settings | Experimental | Patients randomized in the experimental group "special ventilator settings" will receive ventilator settings aimed at reducing airway pressure during FOB. This includes : inspiratory flow <25 L/min, tidal volume = 5 mL/Kg, inspiratory time = 1 sec, respiratory frequency <20c/min, PEEP = 5 cmH2O, and FiO2 = 100% Receives: Other: specific ventilator settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if the use of specific ventilator settings facilitates the performance of fiberoptic bronchoscopy (FOB) during mechanical ventilation compared to conventional ventilator settings.
Occurrence of a serious adverse - ventilatory, respiratory, or circulatory - event prompting the procedure to be interrupted early in the first 5 minutes.
Measured: 5 minutes after bronchoscopy initiation
Secondary outcomes (4)
determine if the specific ventilator settings prevent significant hypoventilation during FOB
Significant reduction in minute ventilation during FOB compared to its initial value
Measured: 5 minutes after bronchoscopy initiation
determine if the specific ventilator settings prevent significant arterial oxygen desaturation during FOB
Significant decrease in the "partial pressure of oxygen in arterial blood (PaO2)"/FiO2 ratio during FOB compared to its initial value
Measured: 5 minutes after bronchoscopy initiation
determine if the specific ventilator settings prevent significant hypercapnia during FOB
Significant increase in PaCO2 during FOB compared to its initial value
Measured: 5 minutes after bronchoscopy initiation
determine if the specific ventilator settings reduce the incidence of hemodynamic adverse event
Significant reduction in episodes of tachycardia, arrythmia, or circulatory instability occurring during the procedure
Measured: 5 minutes after bronchoscopy initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start10 Sep 2024
- Primary completion12 Jun 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Arras
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malcolm LEMYZE, Dr, Principal investigator, arras hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562725
- Sponsor's protocol ID
- 2024-01
- Acronym
- VentSetFib
- Status last verified
- Jul 2025
- First submitted
- 14 Aug 2024
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lemyze M, Granier M, Laouki CE, Belmeguenai A, Chared H, Audegond C, Mallat J. Ventilator settings for fibreoptic bronchoscopy during mechanical ventilation: a study protocol for a pragmatic randomised double-blind controlled trial VentSetFib. BMJ Open. 2025 Feb 26;15(2):e096164. doi: 10.1136/bmjopen-2024-096164.
PubMed 40010841
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilator Settings for Bronchoscopy During Mechanical Ventilation: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06562725
- Acronym / sponsor ID
- VentSetFib / 2024-01
- Conditions
- Mechanical Ventilation Complication, Fiberoptic Bronchoscopy, Critical Illness, Acute Respiratory Failure
- Keywords
- Fiberoptic bronchoscopy, Mechanical Ventilation, acute respiratory failure, Tracheostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Centre Hospitalier ArrasUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 20 Aug 2024 (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.
Fiberoptic bronchoscopy (FOB) can cause a significant increase in respiratory resistances and airway pressure during mechanical ventilation (MV), which can jeopardize the delivery of the ventilatory assistance. This randomized controlled study tests the hypothesis that new ventilator settings aimed at reducing airway pressure may facilitate FOB during MV. Results of this trial should lead to propose a new ventilatory strategy for critically ill patients needing a FOB procedure under MV.
Detailed description
Introduction : Fiberoptic bronchoscopy (FOB) during mechanical ventilation (MV) is a challenging procedure as it considerably reduces the endotracheal tube internal diameter, increasing respiratory resistances, which may compromise the delivering of the ventilatory assistance. According to respiratory physiology principles applied to MV, the reduction of inspiratory flow and tidal volume are likely to reduce airway pressure during the inspiratory phase when respiratory resistances increase. Based on this assumption, we propose new ventilator settings aimed at reducing airway pressure during FOB. This study represents the first investigation to test special ventilator settings in order to facilitate FOB during MV.
Methods and analysis : This is a single-center randomized controlled trial, in which intubated patients undergoing a FOB will be assigned (1/1) either to receive the new ventilatory strategy or to stay on the ventilator settings previously selected by the attending physician. The intervention group will be applied the specific ventilator settings (inspiratory flow \<25 L/min, tidal volume = 5 mL/Kg, inspiratory time = 1 sec, respiratory frequency \<20c/min, positive end expiratory pressure(PEEP) = 5 cmH2O). The primary endpoint will be the reduction of the occurrence of a serious adverse event - inability to deliver the ventilatory support, significant arterial desaturation, or hemodynamics instability - during FOB prompting the interruption of the procedure. The sample size was estimated at a minimum of 46 patients to demonstrate a 50% reduction in the occurrence of such a serious adverse event with a power of 90% and an alpha risk of 0.05 (paired Student t-test).
An adjudication committee evaluates images (scope and monitor) to validate primary endpoint. This is done blinding randomization group.
Results of this trial should lead to propose a new ventilatory strategy for critically ill patients needing a FOB procedure under MV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard ventilator settings | No intervention | –Patients randomized in the control group "standard ventilator settings" will be left on the ventilator settings previously chosen by the attending physician, except Inspired Oxygen Fraction(FiO2) increased to 100% |
| specific ventilator settings | Experimental | Other: specific ventilator settingsPatients randomized in the experimental group "special ventilator settings" will receive ventilator settings aimed at reducing airway pressure during FOB. This includes : inspiratory flow <25 L/min, tidal volume = 5 mL/Kg, inspiratory time = 1 sec, respiratory frequency <20c/min, PEEP = 5 cmH2O, and FiO2 = 100% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years;
- Acute respiratory failure requiring invasive mechanical ventilation in the intensive care unit;
- Indication of either a fiberoptic bronchoscopy (FOB) procedure or a percutaneous tracheostomy under FOB control;
- Patient under sedation with Richmond Agitation and Sedation Scale(RASS) ≤-2,
- Written informed consent obtained by the patient or the patient legal representative
Key exclusion criteria (7 listed)
- Presence of an absolute contraindication to FOB (respiratory arrest, severe acute respiratory distress syndrome (ARDS), refractory shock, uncontrolled heart rhythm disorder);
- Patients in respiratory distress or with severe patient-ventilator desynchronies ;
- Patients refusing FOB;
- Pregnancy ;
- Moribund patients (according to American Society of Anesthesiologists (ASA) Physical status score classification, class 5: high probability of death within 24 hours) or at high risk of death during the FOB procedure;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| specific ventilator settingsThe special ventilator settings used in the intervention group - aimed at reducing airway pressure - include inspiratory flow <25 L/min, tidal volume = 5m L/Kg, inspiratory time = 1 sec, respiratory frequency <20 c/min, PEEP = 5 cmH2O, and FiO2 = 100% | Other | specific ventilator settings |
Primary outcome
Determine if the use of specific ventilator settings facilitates the performance of fiberoptic bronchoscopy (FOB) during mechanical ventilation compared to conventional ventilator settings.
Time frame: 5 minutes after bronchoscopy initiation
Occurrence of a serious adverse - ventilatory, respiratory, or circulatory - event prompting the procedure to be interrupted early in the first 5 minutes.
4 secondary outcomes
determine if the specific ventilator settings prevent significant hypoventilation during FOB
Time frame: 5 minutes after bronchoscopy initiation
determine if the specific ventilator settings prevent significant arterial oxygen desaturation during FOB
Time frame: 5 minutes after bronchoscopy initiation
determine if the specific ventilator settings prevent significant hypercapnia during FOB
Time frame: 5 minutes after bronchoscopy initiation
determine if the specific ventilator settings reduce the incidence of hemodynamic adverse event
Time frame: 5 minutes after bronchoscopy initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Derived from this study: PubMed 40010841Lemyze M, Granier M, Laouki CE, Belmeguenai A, Chared H, Audegond C, Mallat J. Ventilator settings for fibreoptic bronchoscopy during mechanical ventilation: a study protocol for a pragmatic randomised double-blind controlled trial VentSetFib. BMJ Open. 2025 Feb 26;15(2):e096164. doi: 10.1136/bmjopen-2024-096164.
- Individual participant dataSharing planned: No
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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.
Malcolm LEMYZE, Dr principal investigator
arras hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing specific ventilator settings in people with Mechanical Ventilation Complication and Fiberoptic Bronchoscopy, run by Centre Hospitalier Arras 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 8 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if the use of specific ventilator settings facilitates the performance of fiberoptic bronchoscopy (FOB) during mechanical ventilation compared to conventional ventilator settings. (time frame: 5 minutes after bronchoscopy initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06562725, which also lists 1 linked publication.
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 8 Jul 2025.