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Trilogy Comparison Study - Adults

Primary Purpose

Respiratory Insufficiency, Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Trilogy
Standard of Care
Sponsored by
Philips Respironics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Insufficiency

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Manitoba

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trilogy

Standard of Care

Arm Description

Trilogy Device

Participants prescribed ventilator

Outcomes

Primary Outcome Measures

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.
Comparable Level of Gas Exchange SpO2 Levels During Various Modes of Ventilation.
Pulse Oximetry was measured after one hour of use of each ventilator.

Secondary Outcome Measures

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.
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.
Hemodynamics (Heart Rate)
Number of beats per minute. Measured after one hour of use of each device.

Full Information

First Posted
December 17, 2008
Last Updated
January 14, 2021
Sponsor
Philips Respironics
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1. Study Identification

Unique Protocol Identification Number
NCT00810498
Brief Title
Trilogy Comparison Study - Adults
Official Title
Comparing Known Modes of Ventilation Delivered by Trilogy Versus Conventional Mechanical Ventilators
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 12, 2008 (Actual)
Primary Completion Date
February 5, 2009 (Actual)
Study Completion Date
February 5, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Respironics

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency, Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trilogy
Arm Type
Experimental
Arm Description
Trilogy Device
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Participants prescribed ventilator
Intervention Type
Device
Intervention Name(s)
Trilogy
Intervention Description
Exposure for one hour on the Trilogy ventilator
Intervention Type
Device
Intervention Name(s)
Standard of Care
Intervention Description
Exposure to participants current ventilator
Primary Outcome Measure Information:
Title
Comparable Level of Gas Exchange (Measured as Partial Pressure of CO2 in Arterial or Venous Blood).
Description
Blood gas was obtained for this study one hour after use of each device.
Time Frame
After one hour of ventilator use
Title
Comparable Level of Gas Exchange SpO2 Levels During Various Modes of Ventilation.
Description
Pulse Oximetry was measured after one hour of use of each ventilator.
Time Frame
After one hour of ventilator use
Secondary Outcome Measure Information:
Title
Tidal Volume
Description
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.
Title
Minute Ventilation
Description
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.
Title
Hemodynamics (Heart Rate)
Description
Number of beats per minute. Measured after one hour of use of each device.
Time Frame
One hour during ventilator use.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Mink, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0Z3
Country
Canada

12. IPD Sharing Statement

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Trilogy Comparison Study - Adults

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