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)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03689309 |
|
Recruitment Status :
Recruiting
First Posted : September 28, 2018
Last Update Posted : November 8, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Mechanical Ventilation Mechanical Ventilator Weaning Endotracheal Extubation | Procedure: High Flow Oxygen SBT | Not Applicable |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 106 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | 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 |
| Actual Study Start Date : | October 16, 2018 |
| Estimated Primary Completion Date : | October 2020 |
| Estimated Study Completion Date : | October 2020 |
| 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.
|
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 [ Time Frame: Day 7 ]
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
- Reintubation Rate [ Time Frame: Day 7 ]
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
- Success rate of the first SBT [ Time Frame: Day 0 ]Success rate of the first SBT will be compared between the two groups.
- Ventilator free-days [ Time Frame: Day 28 ]Ventilator free-days at day 28 from the admission in ICU
- Rate of Ventilator Associated Pneumonia [ Time Frame: Day 7 ]Rate of Ventilator Associated Pneumonia at day 7 from the extubation
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689309
| Contact: Aurélie DESPUJOLS | +33238744071 | aurelie.despujols@chr-orleans.fr | |
| Contact: Elodie TATSI TOTOUOM | +33238744086 | elodie.tatsi-totouom@chr-orleans.fr |
| France | |
| CHR d'Orleans | Recruiting |
| Orléans, France, 45067 | |
| Contact: Aurélie DESPUJOLS +33238744071 aurelie.despujols@chr-orleans.fr | |
| Contact: Elodie TATSI TOTOUOM +33238744086 elodie.tatsi-totouom@chr-orleans.fr | |
| Principal Investigator: Mai-Anh NAY, Dr | |
| Principal Investigator: | Mai-Anh NAY, Dr | CHR d'Orléans |
Publications:
| Responsible Party: | Centre Hospitalier Régional d'Orléans |
| ClinicalTrials.gov Identifier: | NCT03689309 History of Changes |
| Other Study ID Numbers: |
CHRO-2018-06 |
| First Posted: | September 28, 2018 Key Record Dates |
| Last Update Posted: | November 8, 2018 |
| Last Verified: | September 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Spontaneous breathing Trial High Flow Oxygen |
|
Respiratory Aspiration Respiration Disorders Respiratory Tract Diseases Pathologic Processes |