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:
Collaborator:
Covidien
Information provided by (Responsible Party):
Robert M. Kacmarek, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00790725
First received: November 11, 2008
Last updated: April 24, 2012
Last verified: April 2012
  Purpose

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.

Condition Intervention
Respiration, Artificial
Other: Proportional Assist Ventilation
Other: Pressure Support Ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Proportional Assist Ventilation vs. Pressure Support Ventilation in the Management of Patients Referred to a Respiratory Acute Care Unit

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Length of time mechanically ventilated in the RACU [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sleep quality [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Inflammatory mediator levels [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Hospital mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • 60 day mortality [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • 180 day mortality [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • 365 day mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: November 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PAV
Proportional Assist Ventilation will be used as a mechanical ventilation method for randomized patients in RACU
Other: Proportional Assist Ventilation
Proportional Assist Ventilation will be used to ventilate the patients.
PS
Pressure Support Ventilation will be used as a mechanical ventilation method for randomized patients in RACU
Other: Pressure Support Ventilation
Pressure Support ventilation will be used to ventilate the patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00790725

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Covidien
Investigators
Principal Investigator: Robert M Kacmarek, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Robert M. Kacmarek, Professor of Anesthesia, Director of Respiratory Care Services, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00790725     History of Changes
Other Study ID Numbers: 2008-P-001377
Study First Received: November 11, 2008
Last Updated: April 24, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 28, 2014