Proportional Assist Ventilation vs Pressure Support Ventilation

NCT ID: NCT00790725

Last Updated: 2012-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Respiration, Artificial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PAV

Proportional Assist Ventilation will be used as a mechanical ventilation method for randomized patients in RACU

Group Type OTHER

Proportional Assist Ventilation

Intervention Type OTHER

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

Group Type OTHER

Pressure Support Ventilation

Intervention Type OTHER

Pressure Support ventilation will be used to ventilate the patients.

Interventions

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Proportional Assist Ventilation

Proportional Assist Ventilation will be used to ventilate the patients.

Intervention Type OTHER

Pressure Support Ventilation

Pressure Support ventilation will be used to ventilate the patients.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic - MITG

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Robert M. Kacmarek

Professor of Anesthesia, Director of Respiratory Care Services

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert M Kacmarek, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2008-P-001377

Identifier Type: -

Identifier Source: org_study_id

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