Pressure Support and Positive End Expiratory Pressure During Spontaneous Breathing Trial

Hospices Civils de Lyon98 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Critically Ill Adult Patients With Difficult Weaning

Interventions

Assisted strategyPROCEDURE

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 strategyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital de la Croix-Rousse

Lyon, France

Outcomes

Primary Outcomes

Time (hours) to successful extubation

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

Time frame: 90 days

Secondary Outcomes

Rate of first extubation

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

Time frame: 90 days

Invasive mechanical ventilation duration

time (hours) spent on invasive mechanical ventilation since inclusion

Time frame: 90 days

duration of non-invasive and invasive mechanical ventilation

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

Time frame: 90 days

ventilator-free days at Day 90

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

Time frame: 90 days

Intensive care unit length of stay

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

Time frame: 90 days

hospital length of stay

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

Time frame: 90 days

Day 90 mortality

percentage (%) of patients dead at Day 90

Data from ClinicalTrials.gov

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