Trilogy Comparison Study - Adults

Study Overview
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Brief Summary
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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
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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).

Official Title
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Comparing Known Modes of Ventilation Delivered by Trilogy Versus Conventional Mechanical Ventilators

Conditions
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Respiratory Insufficiency, Respiratory Failure

Intervention / Treatment
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* Device: Trilogy
* Device: Standard of Care


Participation Criteria
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Eligibility Criteria
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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., 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trilogy<br>Trilogy Device | Device: Trilogy<br>* Exposure for one hour on the Trilogy ventilator<br>|
| Active Comparator: Standard of Care<br>Participants prescribed ventilator | Device: Standard of Care<br>* Exposure to participants current ventilator<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tidal Volume | 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. | One hour during ventilator use. | 
| Minute Ventilation | 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. | One hour during ventilator use. | 
| Hemodynamics (Heart Rate) | Number of beats per minute. Measured after one hour of use of each device. | One hour during ventilator use. |