Trilogy Comparison Study - Pediatrics

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 carbon dioxide (CO2) in arterial, venous or capillary blood)and peripheral capillary oxygen saturation, (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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Trilogy Comparison Study - Pediatrics

Conditions
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Respiratory Failure

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 1years of age; < 18 years of age Greater than 5 kg 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: 1 Year
Maximum 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trilogy ventilator<br>Trilogy ventilator | Device: Trilogy Ventilator<br>* Exposure to one hour on the Trilog ventilator<br>|
| Active Comparator: Standard of Care<br>Participants currently prescribed ventilator | Device: Standard of Care<br>* Exposure of one hour on the Participants prescribed 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 Carbon Dioxide (CO2) in Arterial, Venous or Capillary Blood) | Comparable level of gas exchange (measured as partial pressure of CO2 in arterial, venous or capillary blood) | After one hour of ventilator use | 
| Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2) | Comparable level of gas exchange for SpO^2 | After one hour of ventilator use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | heart rate as measured by beats per minute | 60 minutes | 
| Minute Ventilation | Minute ventilation | 60 minutes | 
| Tidal Volume | Tidal Volume | 60 minutes |