Trilogy Comparison Study - Pediatrics
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2008
CompletedFirst Submitted
Initial submission to the registry
December 17, 2008
CompletedFirst Posted
Study publicly available on registry
December 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2009
CompletedResults Posted
Study results publicly available
February 3, 2021
CompletedFebruary 3, 2021
January 1, 2021
11 months
December 17, 2008
October 12, 2020
January 14, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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)
After one hour of ventilator use
Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2)
Comparable level of gas exchange for SpO\^2
After one hour of ventilator use
Secondary Outcomes (3)
Heart Rate
60 minutes
Minute Ventilation
60 minutes
Tidal Volume
60 minutes
Study Arms (2)
Trilogy ventilator
EXPERIMENTALTrilogy ventilator
Standard of Care
ACTIVE COMPARATORParticipants currently prescribed ventilator
Interventions
Exposure of one hour on the Participants prescribed ventilator
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Manitoba
Winnipeg, Manitoba, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeff Jasko
- Organization
- Philips
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Mink, MD
University of Manitoba
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2008
First Posted
December 18, 2008
Study Start
March 10, 2008
Primary Completion
January 26, 2009
Study Completion
January 26, 2009
Last Updated
February 3, 2021
Results First Posted
February 3, 2021
Record last verified: 2021-01