NCT04222569

Determination of the Optimal Spontaneous Breathing Trial During Weaning of Mechanical Ventilation

Determination of the Optimal Spontaneous Breathing Trial During Weaning of Mechanical Ventilation: a Randomized and Personalized Cross Over Physiologic Study in the Perioperative and Critically Ill Patient

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Assessment and comparison of three spontaneous breathing trials in five specific profiles of intensive care unit and perioperative patients. A physiological cross over study

Detailed description

Mechanical ventilation is the most used organ replacement therapy in intensive care unit (ICU). After resolution of acute illness, separating the ventilator from the patient may be specially challenging. Before extubation, it is recommended to perform a spontaneous breathing trial (SBT) to evaluate the ability to sustain breathing with minimal or no support. The way to carry out this step of the weaning process present important variation across regions of the world. Two techniques are preferentially used : the T-piece trial (oxygen supply without positive pressure) and low pressure support ventilation (PSV) from 6 to 10 cmH2O according to the airway humidification device. The best strategy for successful weaning remains unknown, especially about specific subgroups of respiratory and neurological diseases. Our aim is to assess which spontaneous breathing trial would best reproduce post-extubation inspiratory effort. We compare T-piece trial, PSV 7 cmH2O without positive end expiratory pressure (PEEP) and PSV 0 cmH2O without PEEP. Five specific profiles are evaluated : chronic obstructive pulmonary disease (COPD), severe brain injury, blunt thoracic trauma, post abdominal surgery and miscellaneous. The hypothesis is that T-piece trial and PSV 0 CPAP 0 trial are the best for mimic inspiratory effort after extubation. However, we could highlight various results according to different subgroups of ICU patients. The final aim is to determine a personalized wean trial for each.

Conditions

• Intensive Care Unit
• Invasive Mechanical Ventilation
• Ready to Wean From Ventilation

Interventions

Type	Name	Description
PROCEDURE	T-piece	Spontaneous breath trial with a T-piece
PROCEDURE	PSV 7 and PEEP 0	Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure
PROCEDURE	PSV 0 and PEEP 0	Spontaneous breath trial without pressure support ventilation and positive end expiratory pressure, with a patient intubated and connected to the ventilator

Timeline

• Start date: 2020-06-15
• Primary completion: 2023-06-15
• Completion: 2023-06-15
• First posted: 2020-01-10
• Last updated: 2023-08-25

Locations

1 site across 1 country: France