Proportional Assist Ventilation vs Pressure Support Ventilation

Respiration, Artificial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00790725
• Other study ID #: 2008-P-001377
• Status: Terminated
• Phase: N/A
• First received: November 11, 2008
• Last updated: April 24, 2012
• Start date: November 2008
• Est. completion date: May 2010

Study information

• Verified date: April 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiration, Artificial

Intervention

Other:
• Proportional Assist Ventilation
Proportional Assist Ventilation will be used to ventilate the patients.
• Pressure Support Ventilation
Pressure Support ventilation will be used to ventilate the patients.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of time mechanically ventilated in the RACU		30 days	No
Secondary	Sleep quality		48 hours	No
Secondary	Inflammatory mediator levels		30 days	No
Secondary	Hospital mortality		30 days	No
Secondary	60 day mortality		60 days	No
Secondary	180 day mortality		180 days	No
Secondary	365 day mortality		1 year	No