Trilogy Comparison Study - Pediatrics

January 14, 2021 updated by: Philips Respironics
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

Intervention / Treatment

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 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).

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • University of Manitoba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age > 1years of age; < 18 years of age
  2. Greater than 5 kg
  3. 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
  4. 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trilogy ventilator
Device: Trilogy Ventilator
Exposure to one hour on the Trilog ventilator
Active Comparator: Standard of Care
Participants currently prescribed ventilator
Device: Standard of Care
Exposure of one hour on the Participants prescribed 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 Carbon Dioxide (CO2) in Arterial, Venous or Capillary Blood)
Time Frame: After one hour of ventilator use
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)
Time Frame: After one hour of ventilator use
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
Time Frame: 60 minutes
heart rate as measured by beats per minute
60 minutes
Minute Ventilation
Time Frame: 60 minutes
Minute ventilation
60 minutes
Tidal Volume
Time Frame: 60 minutes
Tidal Volume
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Respironics

Investigators

  • Principal Investigator: Steven Mink, MD, University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2008

Primary Completion (Actual)

January 26, 2009

Study Completion (Actual)

January 26, 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

Other Study ID Numbers

  • MR-0713-PTRI-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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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