Trilogy Comparison Study - Adults

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure; Respiratory Insufficiency
• Intervention / Treatment: Device: Trilogy; Device: Standard of Care

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).

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0Z3
      • University of Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trilogy; Trilogy Device	Device: Trilogy; Exposure for one hour on the Trilogy ventilator
Active Comparator: Standard of Care; Participants prescribed ventilator	Device: Standard of Care; Exposure to participants current ventilator

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Philips Respironics
• Investigators: Principal Investigator: Steven Mink, MD, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2008
• Primary Completion (Actual): February 5, 2009
• Study Completion (Actual): February 5, 2009

Study Registration Dates

• First Submitted: December 17, 2008
• First Submitted That Met QC Criteria: December 17, 2008
• First Posted (Estimate): December 18, 2008

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: January 14, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: MR-0609-TRI2-SS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes