Critically Ill Adult Patients With Difficult Weaning
Conditions
Keywords
Critical care, spontaneous breathing trial, T-piece, positive end-expiratory pressure, difficult weaning
Brief summary
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.
Interventions
PROCEDUREAssisted strategy
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.
PROCEDURENon assisted strategy
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.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time (hours) to successful extubation | 90 days | Successful extubation is defined as extubation without retintubation within the 7 following days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Invasive mechanical ventilation duration | 90 days | time (hours) spent on invasive mechanical ventilation since inclusion |
| duration of non-invasive and invasive mechanical ventilation | 90 days | time (hours) spent on invasive or non mechanical ventilation since inclusion |
| ventilator-free days at Day 90 | 90 days | 90 minus the number of days spent on invasive mechanical ventilation (days) since inclusion. Zero day is allocated to dead patients. |
| Rate of first extubation | 90 days | percentage (%) of patients with a first successful extubation divided by the total number of patients per group |
| hospital length of stay | 90 days | time (days) spent in the hospital from inclusion until discharge or death |
| Day 90 mortality | 90 days | percentage (%) of patients dead at Day 90 |
| reintubation rate | 90 days | percentage (%) of the number of patients with any reintubation divided by the number of patients per group |
| Intensive care unit length of stay | 90 days | time (days) spent in intensive care unit from inclusion until discharge or death |
Countries
France
Outcome results
None listed