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NCT Number: 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.

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.

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Key information

Conditions

Mechanical Ventilation Endotracheal Extubation Mechanical Ventilator Weaning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR d'Orleans

Orléans, 45067, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Flow Oxygen SBT

Procedure

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 outcomes

  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:

    • 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

  2. 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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study 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

Acronym: ObiWEAN

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 28, 2018
Registry last updated
Jul 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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