NCT03689309

High Flow Oxygen During Spontaneous Breathing Trial in Patients With High Weaning Risk Failure: Impact on the Weaning Course at D7 From the First Spontaneous Breathing Trial.

High Flow Oxygen During Spontaneous Breathing Trial in Patients With High Weaning Risk Failure: Impact on the Weaning Course at D7 From the First Spontaneous Breathing Trial. A Pilot Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Centre Hospitalier Régional d'Orléans · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In intensive care unit (ICU), mechanical ventilation (MV) is part of routine care. Weaning phase is a daily preoccupation for the caregivers. Prolonged MV can lead to many complications. Failing the weaning phase expose the patient to the need for reintubation, that improves the mortality. The caregiver faces a major problem, in one hand the need to wean properly and quickly and on the other the risk of reintubation. In order to help the clinician making the good choice, the spontaneous breathing trial (SBT) is a key tool. The international literature provides the investigators many ways to perform the SBT. The most common is the T-piece; the patient is disconnected from the ventilator and connected to a T-piece that can provide supplemental oxygen. Another one is the Support pressure trial, the patient is still connected to the ventilator, but the setups are changed to recreate the T-piece conditions. In many French ICU's, the SBT is performed by using a heat humidifier filter that is directly connected to the endotracheal tube, this filter allows the clinician to provide supplemental oxygen in accordance with the patient need. In high risk for reintubation patients, the SBT can create physical stress, that lead to prolonged MV. In our ICU, for those patients, the investigators perform the SBT by connecting the patient to a device that provides high flow oxygen trough endotracheal connector for tracheotomy. The investigators hypothesis that high flow oxygen SBT, will allow the high risk for reintubation patients to succeed the SBT.

Detailed description

The investigators proposed to compare 2 strategies for SBT in high risk for reintubation patients: 1. Classic SBT (C-SBT) 2. High Flow Oxygen SBT (HFO-SBT) This prospective randomized study had 2 conjoint primary outcome: 1. The HFO-SBT shows a better actuarial rate for extubation at day 7 from the begin of the weaning phase 2. Compare the reintubation rate at D7 from the extubation

Conditions

• Mechanical Ventilation
• Mechanical Ventilator Weaning
• Endotracheal Extubation

Interventions

Type	Name	Description
PROCEDURE	High Flow Oxygen SBT	The patient is disconnected from the ventilator and remains 30 minutes without support but high flow oxygen delivered through a dedicated piece that is usually connected on tracheotomy.

Timeline

• Start date: 2018-10-16
• Primary completion: 2020-07-15
• Completion: 2020-07-15
• First posted: 2018-09-28
• Last updated: 2020-07-27

Locations

1 site across 1 country: France