Proportional Assist Ventilation vs Pressure Support Ventilation

Study Overview
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Brief Summary
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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: 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. 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.

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

Conditions
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Respiration, Artificial

Intervention / Treatment
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* Other: Proportional Assist Ventilation
* Other: Pressure Support Ventilation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PAV<br>Proportional Assist Ventilation will be used as a mechanical ventilation method for randomized patients in RACU | Other: Proportional Assist Ventilation<br>* Proportional Assist Ventilation will be used to ventilate the patients.<br>|
| Other: PS<br>Pressure Support Ventilation will be used as a mechanical ventilation method for randomized patients in RACU | Other: Pressure Support Ventilation<br>* Pressure Support ventilation will be used to ventilate the patients.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |