Pressure Support Reduction Versus Spontaneous Breathing Trials in Weaning From Ventilation

The recruitment status of this study is unknown because the information has not been verified recently.
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

May 28, 2009
June 19, 2009
April 2008
September 2009   (final data collection date for primary outcome measure)
Rate of weaning failure [ Time Frame: 48 hours from extubation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00911378 on ClinicalTrials.gov Archive Site
  • Occurence of ventilator associated pneumonia [ Time Frame: Until the date of discharge from hospital ] [ Designated as safety issue: Yes ]
  • Reintubation rates [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
  • Mortality rates [ Time Frame: Until the time of discharge from hospital ] [ Designated as safety issue: Yes ]
  • Duration from start of weaning to extubation [ Time Frame: In hospital stay ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • The influence of weaning outcome on mortality and the other complications of mechanical ventilation [ Time Frame: during hospital stay ] [ Designated as safety issue: Yes ]
  • Occurence of ventilator associated pneumonia [ Time Frame: Till the date of discharge from hospital ] [ Designated as safety issue: Yes ]
  • Reintubation rates [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
  • Mortality rates [ Time Frame: Till the time of discharge from hospital ] [ Designated as safety issue: Yes ]
  • Duration from start of weaning to extubation [ Time Frame: In hospital stay ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Pressure Support Reduction Versus Spontaneous Breathing Trials in Weaning From Ventilation
A Randomized Controlled Trial on Weaning by Pressure Support Reduction Versus Spontaneous Breathing Trials in a Respiratory ICU

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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Health Services Research
  • Respiration, Artificial
  • Ventilator Weaning
  • 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
  • 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
  • Active Comparator: Pressure support ventilation
    Patients in this arm are weaned by gradual reduction of pressure support
    Intervention: Procedure: Pressure support ventilation
  • Active Comparator: Spontaneous breathing trials
    Patients in this arm are weaned by T piece trials
    Intervention: Procedure: Spontaneous breathing trials

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
10 Years to 70 Years
No
Contact: Dr. Ritesh Agarwal, MD, DM +919914209825 riteshpgi@gmail.com
India
 
NCT00911378
weaning2009
Yes
Dr. Ritesh Agarwal, Postgraduate Institute of Medical Education and Research
Postgraduate Institute of Medical Education and Research
Not Provided
Study Director: Dr. Ashutosh Aggarwal, MD, DM Department of Pulmonary Medicine and Critical Care, Postgraduate Institute of Medical Education and Research
Postgraduate Institute of Medical Education and Research
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP