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.

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

Official Title
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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

Conditions
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Mechanical Ventilation, Mechanical Ventilator Weaning, Endotracheal Extubation

Intervention / Treatment
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* Procedure: High Flow Oxygen SBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 yrs. Admission in ICU Mechanically ventilated > 24 hours Mechanically ventilated using support ventilation mode Patient with one of these criterion: Cardiac disease (left ventricular dysfunction LVEF <46%, antecedent of ischemic heart disease, antecedent of acute pulmonary edema) Respiratory disease (COPD, Emphysema, bronchectiasis, asthma, obesity-hypoventilation syndrome, restrictive pulmonary disease) Informed and signed consent from the patient or next of kin. Exclusion Criteria: Head trauma as a cause for ICU admission Neuromuscular disease prior ICU admission Tracheotomized patient Pregnancy Decision not to forgo life sustaining therapy Patient not affiliated with a social security organism Adult private from his liberty with judicial decision Patient that have already been included in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1. Classic SBT (C-SBT)<br>The patient is disconnected from the ventilator and remains 30 minutes without support but oxygen delivered through a heat humidifier filter that is usually connected on tracheotomy. | |
| Experimental: 2. High Flow Oxygen SBT (HFO-SBT)<br>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. | Procedure: High Flow Oxygen SBT<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actuarial rate of extubation | This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients: The HFO-SBT shows a better actuarial rate for extubation at day 7 from the begin of the weaning phase Compare the reintubation rate at D7 from the extubation This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients: The HFO-SBT shows a better actuarial rate for extubation at day 7 from the begin of the weaning phase Compare the reintubation rate at D7 from the extubation | Day 7 | 
| Reintubation Rate | This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients: The HFO-SBT shows a better actuarial rate for extubation at day 7 from the begin of the weaning phase Compare the reintubation rate at D7 from the extubation | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of the first SBT | Success rate of the first SBT will be compared between the two groups. | Day 0 | 
| Ventilator free-days | Ventilator free-days at day 28 from the admission in ICU | Day 28 | 
| Rate of Ventilator Associated Pneumonia | Rate of Ventilator Associated Pneumonia at day 7 from the extubation | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spontaneous breathing Trial, High Flow Oxygen