Trilogy Comparison Study - Adults

Philips Respironics11 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Respiratory Insufficiency Respiratory Failure

Interventions

TrilogyDEVICE

Exposure for one hour on the Trilogy ventilator

Standard of CareDEVICE

Exposure to participants current ventilator

Eligibility

Sex: ALLMin age: 21 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \> 21 years of age; \< 85 years of age 2. Able to follow instructions 3. Able to provide informed consent 4. 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. 5. Requiring mechanical ventilation through nasal/facial mask,tracheostomy or endotracheal tube (ET Tube) Exclusion Criteria: 1. 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. 2. Patients suffering from metastatic or terminal cancer and patients with do-not-resuscitate orders 3. Pregnancy

Locations (1)

University of Manitoba

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: After one hour of ventilator use

Secondary Outcomes

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.

Time frame: 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.

Time frame: One hour during ventilator use.

Hemodynamics (Heart Rate)

Number of beats per minute. Measured after one hour of use of each device.

Time frame: One hour during ventilator use.

Data from ClinicalTrials.gov

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