NCT03689309: ObiWEAN

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.

Completed NA Last updated 27 July 2020

What this trial tests

NA trial testing High Flow Oxygen SBT in Mechanical Ventilation in 106 participants. Completed in 15 July 2020.

Timeline

16 October 2018

Primary endpoint
15 July 2020

15 July 2020

Quick facts

Lead sponsor	Centre Hospitalier Régional d'Orléans
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	106
Start date	16 October 2018
Primary completion	15 July 2020
Estimated completion	15 July 2020
Sites	1 location across France

Drugs / interventions tested

• High Flow Oxygen SBT

Conditions studied

• Mechanical Ventilation — all drugs for Mechanical Ventilation →
• Mechanical Ventilator Weaning — all drugs for Mechanical Ventilator Weaning →
• Endotracheal Extubation — all drugs for Endotracheal Extubation →

Sponsor

Centre Hospitalier Régional d'Orléans

Who can join

18 and older, any sex, with Mechanical Ventilation or Mechanical Ventilator Weaning. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.