Respiration, Artificial
Conditions
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.
Interventions
Proportional Assist Ventilation will be used to ventilate the patients.
OTHERPressure Support Ventilation
Pressure Support ventilation will be used to ventilate the patients.
Sponsors
Medtronic - MITG
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of time mechanically ventilated in the RACU | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory mediator levels | 30 days |
| Hospital mortality | 30 days |
| Sleep quality | 48 hours |
| 180 day mortality | 180 days |
| 365 day mortality | 1 year |
| 60 day mortality | 60 days |
Countries
United States
Outcome results
None listed