Proportional Assist Ventilation vs Pressure Support Ventilation

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

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.

Study Overview

• Status: Terminated
• Conditions: Respiration, Artificial
• Intervention / Treatment: Other: Proportional Assist Ventilation; Other: Pressure Support Ventilation

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Length of time mechanically ventilated in the RACU	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
60 day mortality	60 days
180 day mortality	180 days
Sleep quality	48 hours
Inflammatory mediator levels	30 days
Hospital mortality	30 days
365 day mortality	1 year

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Medtronic - MITG
• Investigators: Principal Investigator: Robert M Kacmarek, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: November 11, 2008
• First Submitted That Met QC Criteria: November 11, 2008
• First Posted (Estimate): November 13, 2008

Study Record Updates

• Last Update Posted (Estimate): April 25, 2012
• Last Update Submitted That Met QC Criteria: April 24, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 2008-P-001377