Pressure Support Reduction Versus Spontaneous Breathing Trials in Weaning From Ventilation

Not Applicable

• Conditions: Respiration, Artificial; Ventilator Weaning
• Interventions: Procedure: Pressure support ventilation; Procedure: Spontaneous breathing trials

• Registration Number: NCT00911378
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief Summary

This study is a comparison of two most commonly used modes of weaning and the outcomes in the two groups.

Detailed Description

Patients ventilated for more than 24 hours are randomized into two groups - one group of patients undergo gradual reduction of pressure support and in the other, T tube trials are used for weaning. The outcomes are compared in the two groups.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-28
• Status Verified: 2009-06
• Study First Posted: 2009-06-01
• Last Update Submitted: 2009-06-19
• Last Update Posted: 2009-06-22
• Primary Completion: 2009-09
• Study Completion: 2009-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Mechanically ventilated patients for more than 24 hours
• Satisfies weaning criteria
• RSBI < 80
• Ratio of PaO2/FiO2 > 250
• Arterial partial pressure of oxygen more than 60 mm Hg and carbon dioxide less than 50 mm Hg

Exclusion Criteria

• Systolic blood pressure of less than 100
• Arterial partial pressure of oxygen less than 60 mm Hg
• Poor sensorium

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pressure support ventilation	Pressure support ventilation	Patients in this arm are weaned by gradual reduction of pressure support
Spontaneous breathing trials	Spontaneous breathing trials	Patients in this arm are weaned by T piece trials

Primary Outcome Measures

Name	Time	Method
Rate of weaning failure	48 hours from extubation

Secondary Outcome Measures

Name	Time	Method
Occurence of ventilator associated pneumonia	Until the date of discharge from hospital
Reintubation rates	48 hours
Mortality rates	Until the time of discharge from hospital
Duration from start of weaning to extubation	In hospital stay
Role of various factors that may influence the weaning outcome and hence predict the probability of successful weaning in a patient	during ICU stay
The influence of weaning outcome on mortality and the other complications of mechanical ventilation	during hospital stay

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, India