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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. (ObiWEAN)

Primary Purpose

Mechanical Ventilation, Mechanical Ventilator Weaning, Endotracheal Extubation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
High Flow Oxygen SBT
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mechanical Ventilation focused on measuring Spontaneous breathing Trial, High Flow Oxygen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHR d'Orleans

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1. Classic SBT (C-SBT)

2. High Flow Oxygen SBT (HFO-SBT)

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Success rate of the first SBT
Success rate of the first SBT will be compared between the two groups.
Ventilator free-days
Ventilator free-days at day 28 from the admission in ICU
Rate of Ventilator Associated Pneumonia
Rate of Ventilator Associated Pneumonia at day 7 from the extubation

Full Information

First Posted
September 27, 2018
Last Updated
July 24, 2020
Sponsor
Centre Hospitalier Régional d'Orléans
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1. Study Identification

Unique Protocol Identification Number
NCT03689309
Brief 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.
Acronym
ObiWEAN
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 16, 2018 (Actual)
Primary Completion Date
July 15, 2020 (Actual)
Study Completion Date
July 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation, Mechanical Ventilator Weaning, Endotracheal Extubation
Keywords
Spontaneous breathing Trial, High Flow Oxygen

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. Classic SBT (C-SBT)
Arm Type
No Intervention
Arm Description
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.
Arm Title
2. High Flow Oxygen SBT (HFO-SBT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
High Flow Oxygen SBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Actuarial rate of extubation
Description
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
Time Frame
Day 7
Title
Reintubation Rate
Description
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
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Success rate of the first SBT
Description
Success rate of the first SBT will be compared between the two groups.
Time Frame
Day 0
Title
Ventilator free-days
Description
Ventilator free-days at day 28 from the admission in ICU
Time Frame
Day 28
Title
Rate of Ventilator Associated Pneumonia
Description
Rate of Ventilator Associated Pneumonia at day 7 from the extubation
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai-Anh NAY, Dr
Organizational Affiliation
CHR d'Orléans
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'Orleans
City
Orléans
ZIP/Postal Code
45067
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23641924
Citation
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.
Results Reference
background
PubMed Identifier
24865303
Citation
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.
Results Reference
background
PubMed Identifier
7921460
Citation
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.
Results Reference
background

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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.

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