Pressure Support Reduction Versus Spontaneous Breathing Trials in Weaning From Ventilation

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

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial on Weaning by Pressure Support Reduction Versus Spontaneous Breathing Trials in a Respiratory ICU

Conditions
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Respiration, Artificial, Ventilator Weaning

Intervention / Treatment
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* Procedure: Pressure support ventilation
* Procedure: Spontaneous breathing trials


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pressure support ventilation<br>Patients in this arm are weaned by gradual reduction of pressure support | Procedure: Pressure support ventilation<br>* These patients are weaned by gradual reduction of pressure support and extubated when they tolerate a pressure support of 7 cm of water for one hour.<br>* Other names: weaning by reduction of pressure support;|
| Active Comparator: Spontaneous breathing trials<br>Patients in this arm are weaned by T piece trials | Procedure: Spontaneous breathing trials<br>* These patients are weaned by giving a T piece trial with 8 cm of water pressure support and extubated when they tolerate it for one hour.<br>* Other names: Weaning by T-piece trials;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of weaning failure |  | 48 hours from extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weaning, mechanical ventilation