Status:
COMPLETED
Trilogy Comparison Study - Adults
Lead Sponsor:
Philips Respironics
Conditions:
Respiratory Insufficiency
Respiratory Failure
Eligibility:
All Genders
21-85 years
Phase:
NA
Brief Summary
The objective of this study (Part II) will be to compare the performance of the Trilogy device and a conventional ventilator (participant's current device). Both devices will be set to the participant...
Detailed Description
A. Primary Hypothesis and end-point In patients with respiratory insufficiency, when compared to conventional ventilators, the Trilogy device achieves comparable level of gas exchange (measured as par...
Eligibility Criteria
Inclusion
- Age \> 21 years of age; \< 85 years of age
- Able to follow instructions
- Able to provide informed consent
- Considered clinically stable, with low flow oxygen requirements less than 15 LPM (or FIO2 less than 60 %) and PEEP no greater than 10 cm H2O.
- Requiring mechanical ventilation through nasal/facial mask,tracheostomy or endotracheal tube (ET Tube)
Exclusion
- Clinically unstable, i.e.,
- Acute Respiratory Failure
- Participants with refractory hypotension defined as systolic blood pressure less than 90 mm Hg despite inotropic agents),
- Uncontrolled cardiac ischemia or arrhythmias,
- or as otherwise determined inappropriate for the study as determined by the investigator.
- Patients suffering from metastatic or terminal cancer and patients with do-not-resuscitate orders
- Pregnancy
Key Trial Info
Start Date :
March 12 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2009
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00810498
Start Date
March 12 2008
End Date
February 5 2009
Last Update
February 3 2021
Active Locations (1)
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1
University of Manitoba
Winnipeg, Manitoba, Canada, R3E 0Z3