Pressure Support Reduction Versus Spontaneous Breathing Trials in Weaning From Ventilation

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

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

Study Overview

• Status: Unknown
• Conditions: Respiration, Artificial; Ventilator Weaning
• Intervention / Treatment: Procedure: Pressure support ventilation; Procedure: Spontaneous breathing trials

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 Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Ritesh Agarwal, MD, DM; Phone Number: +919914209825; Email: riteshpgi@gmail.com

Study Locations

• India
  • Chandigarh, India, 160012
    • Recruiting
    • Postgraduate Institute of Medical Education and Research
    • Contact: Ritesh Agarwal, MD, DM; Phone Number: +919914209825; Email: riteshpgi@gmail.com
    • Contact: Ashutosh Aggarwal, MD, DM; Phone Number: +919914209824; Email: ashutosh@indiachest.org
    • Principal Investigator: Dr. Ashutosh Aggarwal, MD, DM
    • Sub-Investigator: Dr. Karthik G, MD
    • Sub-Investigator: Dr. Ritesh Agarwal, MD, DM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pressure support ventilation; Patients in this arm are weaned by gradual reduction of pressure support	Procedure: Pressure support ventilation; 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.; Other Names: weaning by reduction of pressure support
Active Comparator: Spontaneous breathing trials; Patients in this arm are weaned by T piece trials	Procedure: Spontaneous breathing trials; 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.; Other Names: Weaning by T-piece trials

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Investigators: Study Director: Dr. Ashutosh Aggarwal, MD, DM, Department of Pulmonary Medicine and Critical Care, Postgraduate Institute of Medical Education and Research

Publications and helpful links

General Publications

• Esteban A, Alia I, Gordo F, Fernandez R, Solsona JF, Vallverdu I, Macias S, Allegue JM, Blanco J, Carriedo D, Leon M, de la Cal MA, Taboada F, Gonzalez de Velasco J, Palazon E, Carrizosa F, Tomas R, Suarez J, Goldwasser RS. Extubation outcome after spontaneous breathing trials with T-tube or pressure support ventilation. The Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):459-65. doi: 10.1164/ajrccm.156.2.9610109. Erratum In: Am J Respir Crit Care Med 1997 Dec;156(6):2028.
• Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. doi: 10.1164/ajrccm.150.4.7921460.
• Esteban A, Frutos F, Tobin MJ, Alia I, Solsona JF, Valverdu I, Fernandez R, de la Cal MA, Benito S, Tomas R, et al. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med. 1995 Feb 9;332(6):345-50. doi: 10.1056/NEJM199502093320601.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Anticipated): September 1, 2009
• Study Completion (Anticipated): September 1, 2009

Study Registration Dates

• First Submitted: May 28, 2009
• First Submitted That Met QC Criteria: May 28, 2009
• First Posted (Estimate): June 1, 2009

Study Record Updates

• Last Update Posted (Estimate): June 22, 2009
• Last Update Submitted That Met QC Criteria: June 19, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: mechanical ventilation; weaning
• Other Study ID Numbers: weaning2009