NCT00911378

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

June 22, 2009

Status Verified

June 1, 2009

Enrollment Period

1.4 years

First QC Date

May 28, 2009

Last Update Submit

June 19, 2009

Conditions

Respiration, ArtificialVentilator Weaning

Keywords

weaningmechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Rate of weaning failure

    48 hours from extubation

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Pressure support ventilation

ACTIVE COMPARATOR

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

Procedure: Pressure support ventilation

Spontaneous breathing trials

ACTIVE COMPARATOR

Patients in this arm are weaned by T piece trials

Procedure: Spontaneous breathing trials

Interventions

Pressure support ventilationPROCEDURE

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.

Also known as: weaning by reduction of pressure support
Pressure support ventilation
Spontaneous breathing trialsPROCEDURE

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.

Also known as: Weaning by T-piece trials
Spontaneous breathing trials

Eligibility Criteria

Age10 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Systolic blood pressure of less than 100
  • Arterial partial pressure of oxygen less than 60 mm Hg
  • Poor sensorium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, Chandigarh, 160012, India

RECRUITING

Related Publications (3)

  • 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.

    PMID: 7823995RESULT

  • 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.

    PMID: 7921460RESULT

  • 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.

    PMID: 9279224RESULT

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dr. Ashutosh Aggarwal, MD, DM

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

    STUDY DIRECTOR

Central Study Contacts

Dr. Ritesh Agarwal, MD, DM

CONTACT

+919914209825riteshpgi@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2009

First Posted

June 1, 2009

Study Start

April 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

June 22, 2009

Record last verified: 2009-06

Locations

IN(1)