An interventional study of High Flow Oxygen SBT in Mechanical Ventilation, Mechanical Ventilator Weaning and Endotracheal Extubation, sponsored by Centre Hospitalier Régional d'Orléans. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-27.
Sponsored by Centre Hospitalier Régional d'Orléans · Not applicable, Interventional, and Other
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.
The investigators proposed to compare 2 strategies for SBT in high risk for reintubation patients:
This prospective randomized study had 2 conjoint primary outcome:
1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.
This study's enrollment of 106 is above the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.
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Patient with one of these criterion:
Exclusion Criteria:
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.
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
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.
Actuarial rate of extubation
This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients: 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 This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients: 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
Time frame: Day 7
Reintubation Rate
This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients: 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
Time frame: Day 7
Success rate of the first SBT
Success rate of the first SBT will be compared between the two groups.
Time frame: Day 0
Ventilator free-days
Ventilator free-days at day 28 from the admission in ICU
Time frame: Day 28
Rate of Ventilator Associated Pneumonia
Rate of Ventilator Associated Pneumonia at day 7 from the extubation
Time frame: Day 7
Plan to share: No
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Régional d'Orléans