Proportional Assist Ventilation vs Pressure Support Ventilation

NCT00790725 | Terminated

• 1 other identifier: 2008-P-001377
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Respiration, Artificial

Outcome Measures

Primary Outcomes (1)

• Length of time mechanically ventilated in the RACU

  30 days

Secondary Outcomes (6)

• Sleep quality

  48 hours

• Inflammatory mediator levels

  30 days

• Hospital mortality

  30 days

• 60 day mortality

  60 days

• 180 day mortality

  180 days

Study Arms (2)

PAV

OTHER

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

Other: Proportional Assist Ventilation

PS

OTHER

Pressure Support Ventilation will be used as a mechanical ventilation method for randomized patients in RACU

Other: Pressure Support Ventilation

Interventions

Proportional Assist Ventilation OTHER

Proportional Assist Ventilation will be used to ventilate the patients.

PAV

Pressure Support Ventilation OTHER

Pressure Support ventilation will be used to ventilate the patients.

PS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Tracheotomized or endotracheally intubated and mechanically ventilated patients transferred or scheduled to be transferred to the RACU.
• Age 18 years or older.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Medtronic - MITG: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Interactive Ventilatory Support

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Robert M Kacmarek, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia, Director of Respiratory Care Services

Study Record Dates

• First Submitted: November 11, 2008
• First Posted: November 13, 2008
• Study Start: November 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 25, 2012

Record last verified: 2012-04

Locations

US (1)