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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)

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ClinicalTrials.gov Identifier: NCT03689309
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Régional d'Orléans

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.


Condition or disease Intervention/treatment Phase
Mechanical Ventilation Mechanical Ventilator Weaning Endotracheal Extubation Procedure: High Flow Oxygen SBT Not Applicable

Detailed Description:

The investigators proposed to compare 2 strategies for SBT in high risk for reintubation patients:

  1. Classic SBT (C-SBT)
  2. High Flow Oxygen SBT (HFO-SBT)

This prospective randomized study had 2 conjoint primary outcome:

  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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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.




Primary Outcome Measures :
  1. Actuarial rate of extubation [ Time Frame: Day 7 ]

    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

  2. Reintubation Rate [ Time Frame: Day 7 ]

    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


Secondary Outcome Measures :
  1. Success rate of the first SBT [ Time Frame: Day 0 ]
    Success rate of the first SBT will be compared between the two groups.

  2. Ventilator free-days [ Time Frame: Day 28 ]
    Ventilator free-days at day 28 from the admission in ICU

  3. Rate of Ventilator Associated Pneumonia [ Time Frame: Day 7 ]
    Rate of Ventilator Associated Pneumonia at day 7 from the extubation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Aurélie DESPUJOLS +33238744071 aurelie.despujols@chr-orleans.fr
Contact: Elodie TATSI TOTOUOM +33238744086 elodie.tatsi-totouom@chr-orleans.fr

Locations
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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         
Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
Investigators
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Principal Investigator: Mai-Anh NAY, Dr CHR d'Orléans

Publications:
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Régional d'Orléans:
Spontaneous breathing Trial
High Flow Oxygen
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes