Pressure Support Reduction Versus Spontaneous Breathing Trials in Weaning From Ventilation

NCT ID: NCT00911378

Last Updated: 2009-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-09-30

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.

Conditions

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Respiration, Artificial Ventilator Weaning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Pressure support ventilation

Patients in this arm are weaned by gradual reduction of pressure support

Group Type ACTIVE_COMPARATOR

Pressure support ventilation

Intervention Type PROCEDURE

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

Patients in this arm are weaned by T piece trials

Group Type ACTIVE_COMPARATOR

Spontaneous breathing trials

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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weaning by reduction of pressure support Weaning by T-piece trials

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
Minimum Eligible Age

10 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Postgraduate Institute of Medical Education and Research

Principal Investigators

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Dr. Ashutosh Aggarwal, MD, DM

Role: STUDY_DIRECTOR

Department of Pulmonary Medicine and Critical Care, Postgraduate Institute of Medical Education and Research

Locations

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Postgraduate Institute of Medical Education and Research

Chandigarh, Chandigarh, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Dr. Ritesh Agarwal, MD, DM

Role: CONTACT

+919914209825

Facility Contacts

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Ritesh Agarwal, MD, DM

Role: primary

+919914209825

Ashutosh Aggarwal, MD, DM

Role: backup

+919914209824

References

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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.

Reference Type RESULT
PMID: 7823995 (View on PubMed)

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.

Reference Type RESULT
PMID: 7921460 (View on PubMed)

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.

Reference Type RESULT
PMID: 9279224 (View on PubMed)

Other Identifiers

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weaning2009

Identifier Type: -

Identifier Source: org_study_id

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