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Pressure Support Reduction Versus Spontaneous Breathing Trials in Weaning From Ventilation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Postgraduate Institute of Medical Education and Research.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT00911378
First received: May 28, 2009
Last updated: June 19, 2009
Last verified: June 2009
  Purpose
This study is a comparison of two most commonly used modes of weaning and the outcomes in the two groups.

Condition Intervention
Respiration, Artificial Ventilator Weaning Procedure: Pressure support ventilation Procedure: Spontaneous breathing trials

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Health Services Research
Official Title: A Randomized Controlled Trial on Weaning by Pressure Support Reduction Versus Spontaneous Breathing Trials in a Respiratory ICU

Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Rate of weaning failure [ Time Frame: 48 hours from extubation ]

Secondary Outcome Measures:
  • Occurence of ventilator associated pneumonia [ Time Frame: Until the date of discharge from hospital ]
  • Reintubation rates [ Time Frame: 48 hours ]
  • Mortality rates [ Time Frame: Until the time of discharge from hospital ]
  • Duration from start of weaning to extubation [ Time Frame: In hospital stay ]
  • Role of various factors that may influence the weaning outcome and hence predict the probability of successful weaning in a patient [ Time Frame: during ICU stay ]
  • The influence of weaning outcome on mortality and the other complications of mechanical ventilation [ Time Frame: during hospital stay ]

Estimated Enrollment: 130
Study Start Date: April 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Weaning by T-piece 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.
  Eligibility

Ages Eligible for Study:   10 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911378

Contacts
Contact: Dr. Ritesh Agarwal, MD, DM +919914209825 riteshpgi@gmail.com

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