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Proportional Assist Ventilation vs Pressure Support Ventilation

This study has been terminated.
(The patient population in RACU has changed significantly, we can not find potential subjects to recruit. The enrollment rate has reached zero.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00790725
First Posted: November 13, 2008
Last Update Posted: April 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Robert M. Kacmarek, Massachusetts General Hospital
November 11, 2008
November 13, 2008
April 25, 2012
November 2008
May 2010   (Final data collection date for primary outcome measure)
Length of time mechanically ventilated in the RACU [ Time Frame: 30 days ]
Same as current
Complete list of historical versions of study NCT00790725 on ClinicalTrials.gov Archive Site
  • Sleep quality [ Time Frame: 48 hours ]
  • Inflammatory mediator levels [ Time Frame: 30 days ]
  • Hospital mortality [ Time Frame: 30 days ]
  • 60 day mortality [ Time Frame: 60 days ]
  • 180 day mortality [ Time Frame: 180 days ]
  • 365 day mortality [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
 
Proportional Assist Ventilation vs Pressure Support Ventilation
Proportional Assist Ventilation vs. Pressure Support Ventilation in the Management of Patients Referred to a Respiratory Acute Care Unit

In this study, we want to compare two different kinds of artificial ventilation to see if one encourages faster weaning from breathing support and if one provides better sleep quality. These artificial ventilation types are:

  1. Pressure support ventilation; the standard ventilation that we use for the patients in the Respiratory Acute Care Unit. Pressure support ventilation ventilators use constant air pressure to assist patients with their breathing.
  2. Proportional assist ventilation; a newer way of helping people with their breathing. The air pressure provided by proportional assist ventilation ventilators varies with the size of the breath that a person takes.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Respiration, Artificial
  • Other: Proportional Assist Ventilation
    Proportional Assist Ventilation will be used to ventilate the patients.
  • Other: Pressure Support Ventilation
    Pressure Support ventilation will be used to ventilate the patients.
  • PAV
    Proportional Assist Ventilation will be used as a mechanical ventilation method for randomized patients in RACU
    Intervention: Other: Proportional Assist Ventilation
  • PS
    Pressure Support Ventilation will be used as a mechanical ventilation method for randomized patients in RACU
    Intervention: Other: Pressure Support Ventilation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
May 2010
May 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Tracheotomized or endotracheally intubated and mechanically ventilated patients transferred or scheduled to be transferred to the RACU.
  • Age 18 years or older.

Exclusion Criteria:

  • Patients who are weaned from ventilatory support within the first 72 hours of transfer to the RACU. Even though these patients had been randomized, they will be excluded. They will be considered in the intention to treat analysis but the final outcome analysis will be performed after their exclusion.
  • High spinal cord injury
  • Immunosuppressed patients receiving chemotherapy or radiation therapy (< 2 months after chemotherapy or radiation therapy).
  • Neuromuscular/ neurological disease of a progressive nature resulting in chronic ventilator dependence.
  • High risk of mortality within 3 months (severe neurological damage and cancer patients in terminal stages of the disease).
  • Patients unable to trigger the ventilator for any reason.
  • Any patient who is not considered a candidate for weaning from ventilatory support
  • Patients consented for another interventional study.
  • Patients requiring more than 30 days to wean once randomized will be excluded. They will be considered in the intention to treat analysis but the final outcome analysis will be performed after their exclusion.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00790725
2008-P-001377
No
Not Provided
Not Provided
Robert M. Kacmarek, Massachusetts General Hospital
Massachusetts General Hospital
Medtronic - MITG
Principal Investigator: Robert M Kacmarek, PhD Massachusetts General Hospital
Massachusetts General Hospital
April 2012

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