An interventional study of specific ventilator settings in Mechanical Ventilation Complication, Fiberoptic Bronchoscopy and Critical Illness, sponsored by Centre Hospitalier Arras. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-08.
Sponsored by Centre Hospitalier Arras · Not applicable, Interventional, and Treatment
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.
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.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 46 is below the median of 90 across 979 interventional studies indexed under Critical Illness.
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Exclusion Criteria:
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%
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
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%
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.
Time frame: 5 minutes after bronchoscopy initiation
determine if the specific ventilator settings prevent significant hypoventilation during FOB
Significant reduction in minute ventilation during FOB compared to its initial value
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5 minutes after bronchoscopy initiation
Plan to share: No
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Arras