Proportional Assist Ventilation vs Pressure Support Ventilation

Not Applicable

Terminated

• Conditions: Respiration, Artificial
• Interventions: Other: Proportional Assist Ventilation; Other: Pressure Support Ventilation

• Registration Number: NCT00790725
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-11
• Study First Submitted QC: 2008-11-11
• Study First Posted: 2008-11-13
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-24
• Last Update Posted: 2012-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAV	Proportional Assist Ventilation	Proportional Assist Ventilation will be used as a mechanical ventilation method for randomized patients in RACU
PS	Pressure Support Ventilation	Pressure Support Ventilation will be used as a mechanical ventilation method for randomized patients in RACU

Primary Outcome Measures

Name	Time	Method
Length of time mechanically ventilated in the RACU	30 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States