Pressure Support and Positive End Expiratory Pressure During Spontaneous Breathing Trial (SBT-ICU)

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Civil Hospices of Lyon

Status

Completed

Conditions

Critically Ill Adult Patients With Difficult Weaning

Treatments

Procedure: Non assisted strategy
Procedure: Assisted strategy

Study type

Interventional

Funder types

Other

Identifiers

NCT03861117
69HCL18_0982
2019-A00106-51 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

98 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

98 participants in 2 patient groups

Assisted strategy
Experimental group
Description:
Ability to be weaned is determined with pressure support and positive end-expiratory pressure.
Treatment:
Procedure: Assisted strategy
Non assisted strategy
Active Comparator group
Description:
Ability to be weaned is determined with T-piece.
Treatment:
Procedure: Non assisted strategy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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