Clinical trial NCT00911378: Pressure Support Reduction Versus Spontaneous Breathing Trials in Weaning From Ventilation
Official title: A Randomized Controlled Trial on Weaning by Pressure Support Reduction Versus Spontaneous Breathing Trials in a Respiratory ICU
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiration, Artificial
Ventilator Weaning
Keywords: weaning
mechanical ventilation
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2009-06-01
Enrollment: 130
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of weaning failure
timeFrame: 48 hours from extubation
Secondary outcomes:
measure: Occurence of ventilator associated pneumonia
timeFrame: Until the date of discharge from hospital
measure: Reintubation rates
timeFrame: 48 hours
measure: Mortality rates
timeFrame: Until the time of discharge from hospital
measure: Duration from start of weaning to extubation
timeFrame: In hospital stay
measure: Role of various factors that may influence the weaning outcome and hence predict the probability of successful weaning in a patient
timeFrame: during ICU stay
measure: The influence of weaning outcome on mortality and the other complications of mechanical ventilation
timeFrame: during hospital stay
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
Study officials:
affiliation: Department of Pulmonary Medicine and Critical Care, Postgraduate Institute of Medical Education and Research
name: Dr. Ashutosh Aggarwal, MD, DM
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.