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Completed

NCT Number: NCT03861117

Pressure Support and Positive End Expiratory Pressure During Spontaneous Breathing Trial

The aim of this study is to assess if a bundle associating pressure support and positive end-expiratory pressure during spontaneous breathing trial and detection by T-piece of patients with high-risk of extubation failure can reduce the time to successful extubation in critically ill patients.

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Key information

Conditions

Critically Ill Adult Patients With Difficult Weaning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital de la Croix-Rousse

Lyon, 69317, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient 18 years old or more
  • Intubated and ventilated in intensive care unit for more than 24 hours
  • Patient ready for weaning evaluation
  • Failure of a first T-piece SBT

Exclusion criteria

  • Chronic neuromuscular disease
  • Guillain-Barré Syndrome
  • Central nervous system disease with consciousness disorder
  • Tracheostomy
  • Chronic disease with life expectancy less than 1 year
  • Pregnancy, breast feeding
  • Withholding life support regarding a reintubation
  • Prisoner or patient interned in psychiatric hospital
  • Guardianship
  • Language barrier
  • Lack of medical insurance
  • Lack of the patient's consent (or of the next of kin where appropriate)
  • Patient under an exclusion period after enrollment in another research study

Treatment and study plan

Assisted strategy

Procedure

Daily spontaneous breathing trial (SBT) with 7 cmH2O pressure support and 5 cmH2O positive end-expiratory pressure are performed to assess weanability. In case of success, a SBT with T-piece is performed to determine if the patients is at high risk of extubation failure. In this case and/or in the presence of risk factors, systematic non-invasive ventilation is applied after extubation.

Non assisted strategy

Procedure

Daily spontaneous breathing trials (SBT) with T-piece are performed to assess weanability. In the presence of risk factors, systematic non-invasive ventilation is applied after extubation.

Primary outcomes

  1. Time (hours) to successful extubation

    Time frame: 90 days

    Successful extubation is defined as extubation without retintubation within the 7 following days.

Secondary outcomes

  1. Rate of first extubation

    Time frame: 90 days

    percentage (%) of patients with a first successful extubation divided by the total number of patients per group

  2. Invasive mechanical ventilation duration

    Time frame: 90 days

    time (hours) spent on invasive mechanical ventilation since inclusion

  3. duration of non-invasive and invasive mechanical ventilation

    Time frame: 90 days

    time (hours) spent on invasive or non mechanical ventilation since inclusion

  4. ventilator-free days at Day 90

    Time frame: 90 days

    90 minus the number of days spent on invasive mechanical ventilation (days) since inclusion. Zero day is allocated to dead patients.

  5. Intensive care unit length of stay

    Time frame: 90 days

    time (days) spent in intensive care unit from inclusion until discharge or death

  6. hospital length of stay

    Time frame: 90 days

    time (days) spent in the hospital from inclusion until discharge or death

  7. Day 90 mortality

    Time frame: 90 days

    percentage (%) of patients dead at Day 90

  8. reintubation rate

    Time frame: 90 days

    percentage (%) of the number of patients with any reintubation divided by the number of patients per group

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Impact of the Combination of Pressure Support and Positive End Expiratory Pressure During Spontaneous Breathing Trial Versus T-piece on the Time to Successful Extubation

Acronym: SBT-ICU

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 4, 2019
Registry last updated
Dec 19, 2025

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.