Trilogy Comparison Study - Pediatrics

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
• Intervention / Treatment: Device: Trilogy Ventilator; 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 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

Study Locations

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

Participation Criteria

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

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 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)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	heart rate as measured by beats per minute	60 minutes
Minute Ventilation	Minute ventilation	60 minutes
Tidal Volume	Tidal Volume	60 minutes

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 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: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• 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