- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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. (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. A Pilot Randomized Controlled Trial
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Orléans, France, 45067
- CHR d'Orléans
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 1. Classic SBT (C-SBT)
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)
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Actuarial rate of extubation
Time Frame: Day 7
|
This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients:
This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients:
|
Day 7
|
Reintubation Rate
Time Frame: Day 7
|
This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients:
|
Day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success rate of the first SBT
Time Frame: Day 0
|
Success rate of the first SBT will be compared between the two groups.
|
Day 0
|
Ventilator free-days
Time Frame: Day 28
|
Ventilator free-days at day 28 from the admission in ICU
|
Day 28
|
Rate of Ventilator Associated Pneumonia
Time Frame: Day 7
|
Rate of Ventilator Associated Pneumonia at day 7 from the extubation
|
Day 7
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mai-Anh NAY, Dr, CHR d'Orléans
Publications and helpful links
General Publications
- Thille AW, Richard JC, Brochard L. The decision to extubate in the intensive care unit. Am J Respir Crit Care Med. 2013 Jun 15;187(12):1294-302. doi: 10.1164/rccm.201208-1523CI.
- Ladeira MT, Vital FM, Andriolo RB, Andriolo BN, Atallah AN, Peccin MS. Pressure support versus T-tube for weaning from mechanical ventilation in adults. Cochrane Database Syst Rev. 2014 May 27;2014(5):CD006056. doi: 10.1002/14651858.CD006056.pub2.
- Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. doi: 10.1164/ajrccm.150.4.7921460.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHRO-2018-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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