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NCT Number: NCT04227639

T-piece Versus Pressure-support for the Spontaneous Breathing Trial

The main objective will be to compare the number of ventilator-free days within the 28 days following the first spontaneous breathing trial between strategies of extubation performing spontaneous breathing trials with T-piece trials or with Pressure-Support trials.

To do that, the study director proposed to conduct a prospective multicenter randomized controlled open-label trial comparing these 2 strategies of weaning in patients at high-risk of extubation failure in the Intensive Care Unit.

Patients included will be randomized before performing the first spontaneous breathing trial and will be assigned to one of the following two groups according to the weaning strategy: T-piece trial group or Pressure-Support trial group.

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Key information

Conditions

Weaning From Mechanical Ventilation Extubation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intensive reanimation

Poitiers, 86000, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Duration of mechanical ventilation prior to the first spontaneous brathing trial > 24h
  • Patients at high-risk of reintubation according to the following criteria: Patients older than 65 years, or those having any underlying chronic cardiac or lung disease.
  • Patient meeting all weaning criteria according to the international conference consensus on weaning.
  • Respiratory rate ≤ 35 breaths per minute,
  • Adequate oxygenation defined as SpO2 > 90% with FiO2 ≤ 0.4 or PaO2/FiO2 > 150 mm Hg with positive end-expiratory pressure (PEEP) ≤ 8 cmH2O,
  • Adequate cough,
  • Patient awake with a Richmond Agitation-Sedation Scale between +1 and -2
  • No continuous sedation,
  • Hemodynamic stability with no need for vasopressors (or minimal dosis).
  • Informed consent given by the relatives or the patient himself.

Exclusion criteria

  • Patients admitted for traumatic brain injury
  • Pre-existing peripheral neuromuscular disease (underlying myopathy or myasthenia gravis)
  • Do-not-reintubate order at time of the first spontaneous breathing trial
  • Patient previously included in the study
  • No Health insurance coverage
  • People under protection: Pregnant or breastfeeding women, minor patients, subjects with guardianship or under law protection.
  • Refusal to participate

Treatment and study plan

T-piece trial

Procedure

T-piece trial will be performed for around 1 hour with a T-piece connected to the extremity of the endotracheal tube by simply disconnecting the patient from the ventilator and by providing additional oxygen (≤ 6 L/min)

Pressure-support trial

Procedure

Pressure-Support trial will be performed for around 1 hour without disconnecting the patient from the ventilator, by using a low level of pressure-support (PS 8 cm H2O) with a FiO2 ≤ 40% and without positive end-expiratory pressure (PEEP), while continuously monitoring the respiratory rate and tidal volume on the ventilator display.

Primary outcomes

  1. Number of ventilator-free days at day 28

    Time frame: Day 28

    The number of ventilator-free days at day 28, defined as the number of days alive and without invasive mechanical ventilation (intubation or tracheostomy) between the first spontaneous breathing trial (day 1) and day 28.

Secondary outcomes

  1. The number of days alive and without mechanical ventilation (including intubation or non-invasive ventilation) between the first spontaneous breathing trial (day 1) and day 28.

    Time frame: Between Day 1 and Day 28

  2. The number of patients extubated within the 72 hours and within the 7 days following the first spontaneous breathing trial.

    Time frame: Hour 72, Day 7

  3. The number of patients extubated after simple (24h), difficult (> 24 hours and ≤ 7 days) or prolonged ( > 7 days) weaning

    Time frame: Day 28

  4. The number of patients extubated after the first spontaneous breathing trial and not reintubated within the following 72 hours.

    Time frame: Hour 72

  5. The number of days between the first spontaneous breathing trial and the first extubation attempt among extubated patients

    Time frame: Day 28

  6. The number of patients reintubated within the 72 hours and within the 7 days following extubation.

    Time frame: Day 28

  7. The number of patients with post-extubation respiratory failure within the 7 days following extubation.

    Time frame: Day 28

  8. Length of stay in ICU in days.

    Time frame: Day 90

  9. Numbers of patients died in ICU, at day 28 and at day 90.

    Time frame: Day 28 and Day 90

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

T-piece Versus Pressure-support for the Spontaneous Breathing Trial Before Extubation in Patients at High-risk of Reintubation: a Multicenter Randomized Controlled Trial

Acronym: TiP-Ex

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 13, 2020
Registry last updated
May 12, 2022

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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