Ventilator Settings for Bronchoscopy During Mechanical Ventilation: a Randomized Controlled Study

NCT06562725 | Completed

• 1 other identifier: 2024-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mechanical Ventilation Complication; Fiberoptic Bronchoscopy; Critical Illness; Acute Respiratory Failure

Keywords

Fiberoptic bronchoscopy; Mechanical Ventilation; acute respiratory failure; Tracheostomy

Outcome Measures

Primary Outcomes (1)

• 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.

  5 minutes after bronchoscopy initiation

Secondary Outcomes (4)

• determine if the specific ventilator settings prevent significant hypoventilation during FOB

  5 minutes after bronchoscopy initiation

• determine if the specific ventilator settings prevent significant arterial oxygen desaturation during FOB

  5 minutes after bronchoscopy initiation

• determine if the specific ventilator settings prevent significant hypercapnia during FOB

  5 minutes after bronchoscopy initiation

• determine if the specific ventilator settings reduce the incidence of hemodynamic adverse event

  5 minutes after bronchoscopy initiation

Study Arms (2)

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%

Other: specific ventilator settings

Interventions

specific ventilator settings OTHER

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%

specific ventilator settings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Arras: lead

Study Sites (1)

Arras Hospital

Arras, France, 62000, France

Location

Related Publications (1)

• 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.

  PMID: 40010841 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Malcolm LEMYZE, Dr

  arras hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 20, 2024
• Study Start: September 10, 2024
• Primary Completion: June 12, 2025
• Study Completion: June 19, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)