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Clinical Trials/NCT00790725
NCT00790725
Terminated
N/A

Proportional Assist Ventilation vs. Pressure Support Ventilation in the Management of Patients Referred to a Respiratory Acute Care Unit

Massachusetts General Hospital1 site in 1 country12 target enrollmentNovember 2008

Overview

Phase
N/A
Intervention
Not specified
Conditions
Respiration, Artificial
Sponsor
Massachusetts General Hospital
Enrollment
12
Locations
1
Primary Endpoint
Length of time mechanically ventilated in the RACU
Status
Terminated
Last Updated
14 years ago

Overview

Brief Summary

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.
Registry
clinicaltrials.gov
Start Date
November 2008
End Date
May 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Robert M. Kacmarek

Professor of Anesthesia, Director of Respiratory Care Services

Massachusetts General Hospital

Eligibility 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.

Outcomes

Primary Outcomes

Length of time mechanically ventilated in the RACU

Time Frame: 30 days

Secondary Outcomes

  • Sleep quality(48 hours)
  • Inflammatory mediator levels(30 days)
  • Hospital mortality(30 days)
  • 60 day mortality(60 days)
  • 180 day mortality(180 days)
  • 365 day mortality(1 year)

Study Sites (1)

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