Back to resultsTrilogy Comparison Study - Pediatrics
Primary Purpose
Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Trilogy Ventilator
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Failure
Eligibility Criteria
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
Sites / Locations
- University of Manitoba
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Trilogy ventilator
Standard of Care
Arm Description
Trilogy ventilator
Participants currently prescribed ventilator
Outcomes
Primary Outcome Measures
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)
Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2)
Comparable level of gas exchange for SpO^2
Secondary Outcome Measures
Heart Rate
heart rate as measured by beats per minute
Minute Ventilation
Minute ventilation
Tidal Volume
Tidal Volume
Full Information
NCT ID
NCT00810459
First Posted
December 17, 2008
Last Updated
January 14, 2021
Sponsor
Philips Respironics
1. Study Identification
Unique Protocol Identification Number
NCT00810459
Brief Title
Trilogy Comparison Study - Pediatrics
Official Title
Trilogy Comparison Study - Pediatrics
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 10, 2008 (Actual)
Primary Completion Date
January 26, 2009 (Actual)
Study Completion Date
January 26, 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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trilogy ventilator
Arm Type
Experimental
Arm Description
Trilogy ventilator
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Participants currently prescribed ventilator
Intervention Type
Device
Intervention Name(s)
Trilogy Ventilator
Intervention Description
Exposure to one hour on the Trilog ventilator
Intervention Type
Device
Intervention Name(s)
Standard of Care
Intervention Description
Exposure of one hour on the Participants prescribed ventilator
Primary Outcome Measure Information:
Title
Comparable Level of Gas Exchange (Measured as Partial Pressure of Carbon Dioxide (CO2) in Arterial, Venous or Capillary Blood)
Description
Comparable level of gas exchange (measured as partial pressure of CO2 in arterial, venous or capillary blood)
Time Frame
After one hour of ventilator use
Title
Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2)
Description
Comparable level of gas exchange for SpO^2
Time Frame
After one hour of ventilator use
Secondary Outcome Measure Information:
Title
Heart Rate
Description
heart rate as measured by beats per minute
Time Frame
60 minutes
Title
Minute Ventilation
Description
Minute ventilation
Time Frame
60 minutes
Title
Tidal Volume
Description
Tidal Volume
Time Frame
60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Country
Canada
12. IPD Sharing Statement
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Trilogy Comparison Study - Pediatrics
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