Clinical trial NCT00790725: Proportional Assist Ventilation vs Pressure Support Ventilation
Official title: Proportional Assist Ventilation vs. Pressure Support Ventilation in the Management of Patients Referred to a Respiratory Acute Care Unit
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiration, Artificial
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2008-11-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Length of time mechanically ventilated in the RACU
timeFrame: 30 days
Secondary outcomes:
measure: Sleep quality
timeFrame: 48 hours
measure: Inflammatory mediator levels
timeFrame: 30 days
measure: Hospital mortality
timeFrame: 30 days
measure: 60 day mortality
timeFrame: 60 days
measure: 180 day mortality
timeFrame: 180 days
measure: 365 day mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Robert M Kacmarek, PhD
role: PRINCIPAL_INVESTIGATOR
References: