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

Last updated: September 23, 2024
Sponsor: Centre Hospitalier Arras
Overall Status: Active - Recruiting

Phase

N/A

Condition

Respiratory Failure

Bronchoscopy

Lung Injury

Treatment

specific ventilator settings

Clinical Study ID

NCT06562725
2024-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years;

  • Acute respiratory failure requiring invasive mechanical ventilation in the intensivecare unit;

  • Indication of either a fiberoptic bronchoscopy (FOB) procedure or a percutaneoustracheostomy 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

Exclusion

Exclusion Criteria:

  • Presence of an absolute contraindication to FOB (respiratory arrest, severe acuterespiratory distress syndrome (ARDS), refractory shock, uncontrolled heart rhythmdisorder);

  • Patients in respiratory distress or with severe patient-ventilator desynchronies ;

  • Patients refusing FOB;

  • Pregnancy ;

  • Moribund patients (according to American Society of Anesthesiologists (ASA) Physicalstatus score classification, class 5: high probability of death within 24 hours) orat high risk of death during the FOB procedure;

  • Patients deprived of liberty;

  • Patients under curators or guardianship.

Study Design

Total Participants: 46
Treatment Group(s): 1
Primary Treatment: specific ventilator settings
Phase:
Study Start date:
September 10, 2024
Estimated Completion Date:
September 30, 2026

Study 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.

Connect with a study center

  • Arras Hospital

    Arras, 62000
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.