Trilogy Comparison Study - Adults

Not Applicable

Completed

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 participants' current mode and prescription settings.

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 partial pressure of CO2 in arterial or venous blood)and SpO2 levels during various modes of ventilation.

B. Secondary Hypothesis and end-points In patients with respiratory insufficiency, when compared to conventional ventilators, the Trilogy device achieves comparable breathing pattern (tidal volume, respiratory rate, minute ventilation), hemodynamics (heart rate), and subjective measures of breathing comfort (measured by modified Borg dyspnea scale).

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

Clinically unstable, i.e.,
1. Acute Respiratory Failure
2. Participants with refractory hypotension defined as systolic blood pressure less than 90 mm Hg despite inotropic agents),
3. Uncontrolled cardiac ischemia or arrhythmias,
4. 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

Arm && Interventions

Group	Intervention	Description
Trilogy	Trilogy	Trilogy Device
Standard of Care	Standard of Care	Participants prescribed ventilator

Primary Outcome Measures

Name	Time	Method
Comparable Level of Gas Exchange (Measured as Partial Pressure of CO2 in Arterial or Venous Blood).	After one hour of ventilator use	Blood gas was obtained for this study one hour after use of each device.
Comparable Level of Gas Exchange SpO2 Levels During Various Modes of Ventilation.	After one hour of ventilator use	Pulse Oximetry was measured after one hour of use of each ventilator.

Secondary Outcome Measures

Name	Time	Method
Tidal Volume	One hour during ventilator use.	Tidal volume is the amount of air that moves in or out of the lungs with each respiratory cycle. It measures around 500 mL in an average healthy adult male and approximately 400 mL in a healthy female. Average tidal volume was compare after a hour of use of each device.
Minute Ventilation	One hour during ventilator use.	Minute ventilation is the volume of gas inhaled or exhaled from a person's lungs per minute. This was measured after one hour of use of each device.
Hemodynamics (Heart Rate)	One hour during ventilator use.	Number of beats per minute. Measured after one hour of use of each device.