Pressure Support Reduction Versus Spontaneous Breathing Trials in Weaning From Ventilation

Respiration, Artificial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00911378
• Other study ID #: weaning2009
• Status: Recruiting
• Phase: N/A
• First received: May 28, 2009
• Last updated: June 19, 2009
• Start date: April 2008
• Est. completion date: September 2009

Study information

• Verified date: June 2009
• Source: Postgraduate Institute of Medical Education and Research
• Contact: Dr. Ritesh Agarwal, MD, DM
• Phone: +919914209825
• Email: riteshpgi[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Respiration, Artificial
• Ventilator Weaning

Intervention

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.
• 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.

Locations

Country	Name	City	State
India	Postgraduate Institute of Medical Education and Research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

References & Publications (3)

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. — View Citation

Esteban A, Alía I, Gordo F, Fernández R, Solsona JF, Vallverdú I, Macías S, Allegue JM, Blanco J, Carriedo D, León M, de la Cal MA, Taboada F, Gonzalez de Velasco J, Palazón E, Carrizosa F, Tomás R, Suarez J, Goldwasser RS. Extubation outcome after sponta — View Citation

Esteban A, Frutos F, Tobin MJ, Alía I, Solsona JF, Valverdú I, Fernández R, de la Cal MA, Benito S, Tomás R, et al. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med. 1995 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of weaning failure		48 hours from extubation	Yes
Secondary	Occurence of ventilator associated pneumonia		Until the date of discharge from hospital	Yes
Secondary	Reintubation rates		48 hours	Yes
Secondary	Mortality rates		Until the time of discharge from hospital	Yes
Secondary	Duration from start of weaning to extubation		In hospital stay	Yes
Secondary	Role of various factors that may influence the weaning outcome and hence predict the probability of successful weaning in a patient		during ICU stay	Yes
Secondary	The influence of weaning outcome on mortality and the other complications of mechanical ventilation		during hospital stay	Yes