Proportional Assist Ventilation vs Pressure Support Ventilation - Full Text View

Sponsors and Collaborators:	Massachusetts General Hospital Covidien
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00790725

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:

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.
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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
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 ]

Estimated Enrollment:	200
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790725

Contacts

Contact: Robert M Kacmarek, PhD

617-7244480

rkacmarek@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Robert Kacmarek, PhD,RRT 617-724-4480 rkacmarek@partners.org
Contact: Demet Suleymanci, MD 617-724 4498 dsuleymanci@partners.org

Sponsors and Collaborators

Massachusetts General Hospital

Covidien

Investigators

Principal Investigator:

Robert M Kacmarek, PhD

Massachusetts General Hospital

More Information

Responsible Party:	Massachusetts General Hospital ( Robert Kacmarek, PhD, RRT )
Study ID Numbers:	2008-P-001377
Study First Received:	November 11, 2008
Last Updated:	November 11, 2008
ClinicalTrials.gov Identifier:	NCT00790725
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on January 16, 2009