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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04227639
Other study ID # TiP-Ex
Secondary ID 2019-A02151-56
Status Completed
Phase N/A
First received
Last updated
Start date January 31, 2020
Est. completion date September 7, 2021

Study information

Verified date May 2022
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date September 7, 2021
Est. primary completion date June 7, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Duration of mechanical ventilation prior to the first spontaneous brathing trial > 24h 2. 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. 3. 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). 4. Informed consent given by the relatives or the patient himself. Exclusion Criteria: 1. Patients admitted for traumatic brain injury 2. Pre-existing peripheral neuromuscular disease (underlying myopathy or myasthenia gravis) 3. Do-not-reintubate order at time of the first spontaneous breathing trial 4. Patient previously included in the study 5. No Health insurance coverage 6. People under protection: Pregnant or breastfeeding women, minor patients, subjects with guardianship or under law protection. 7. Refusal to participate

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
T-piece trial
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
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.

Locations

Country Name City State
France Intensive reanimation Poitiers

Sponsors (1)

Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of ventilator-free days at 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. Day 28
Secondary 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. Between Day 1 and Day 28
Secondary The number of patients extubated within the 72 hours and within the 7 days following the first spontaneous breathing trial. Hour 72, Day 7
Secondary The number of patients extubated after simple (24h), difficult (> 24 hours and = 7 days) or prolonged ( > 7 days) weaning Day 28
Secondary The number of patients extubated after the first spontaneous breathing trial and not reintubated within the following 72 hours. Hour 72
Secondary The number of days between the first spontaneous breathing trial and the first extubation attempt among extubated patients Day 28
Secondary The number of patients reintubated within the 72 hours and within the 7 days following extubation. Day 28
Secondary The number of patients with post-extubation respiratory failure within the 7 days following extubation. Day 28
Secondary Length of stay in ICU in days. Day 90
Secondary Numbers of patients died in ICU, at day 28 and at day 90. Day 28 and Day 90
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