Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562725
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Ventilator Settings for Bronchoscopy During Mechanical Ventilation a Randomized Controlled Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ventilator Settings for Bronchoscopy During Mechanical Ventilation a Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VentSetFib
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
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 11 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 lt25 Lmin tidal volume 5 mLKg inspiratory time 1 sec respiratory frequency lt20cmin positive end expiratory pressurePEEP 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 005 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
Methods and analysis This is a single-center randomized controlled trial in which intubated patients undergoing a FOB will be assigned 11 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 lt25 Lmin tidal volume 5 mLKg inspiratory time 1 sec respiratory frequency lt20cmin positive end expiratory pressurePEEP 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 005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None