Pressure Support and Positive End Expiratory Pressure During Spontaneous Breathing Trial

Critically Ill Adult Patients With Difficult Weaning Clinical Trial

— SBT-ICU  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03861117
• Other study ID #: 69HCL18_0982
• Secondary ID: 2019-A00106-51
• Status: Completed
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: June 1, 2023

Study information

• Verified date: February 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill Adult Patients With Difficult Weaning

Intervention

Procedure:
• Assisted 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.
• Non 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.

Locations

Country	Name	City	State
France	Hôpital de la Croix-Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time (hours) to successful extubation	Successful extubation is defined as extubation without retintubation within the 7 following days.	90 days
Secondary	Rate of first extubation	percentage (%) of patients with a first successful extubation divided by the total number of patients per group	90 days
Secondary	Invasive mechanical ventilation duration	time (hours) spent on invasive mechanical ventilation since inclusion	90 days
Secondary	duration of non-invasive and invasive mechanical ventilation	time (hours) spent on invasive or non mechanical ventilation since inclusion	90 days
Secondary	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.	90 days
Secondary	Intensive care unit length of stay	time (days) spent in intensive care unit from inclusion until discharge or death	90 days
Secondary	hospital length of stay	time (days) spent in the hospital from inclusion until discharge or death	90 days
Secondary	Day 90 mortality	percentage (%) of patients dead at Day 90	90 days
Secondary	reintubation rate	percentage (%) of the number of patients with any reintubation divided by the number of patients per group	90 days