Trilogy Comparison Study - Pediatrics

Not Applicable

Completed

• Conditions: Respiratory Failure
• Interventions: Device: Standard of Care; Device: Trilogy Ventilator

• Registration Number: NCT00810459
• Lead Sponsor: Philips Respironics

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).

Study Timeline

• Study Start: 2008-03-10
• Study First Submitted: 2008-12-17
• Study First Submitted QC: 2008-12-17
• Study First Posted: 2008-12-18
• Primary Completion: 2009-01-26
• Study Completion: 2009-01-26
• Disposition First Submitted: 2018-12-06
• Disposition First Submitted QC: 2018-12-06
• Results First Submitted: 2020-10-12
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-14
• Last Update Submitted: 2021-01-14
• Results First Posted: 2021-02-03
• Disposition First Posted: 2021-02-03
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	Participants currently prescribed ventilator
Trilogy ventilator	Trilogy Ventilator	Trilogy ventilator

Primary Outcome Measures

Name	Time	Method
Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2)	After one hour of ventilator use	Comparable level of gas exchange for SpO\^2
Comparable Level of Gas Exchange (Measured as Partial Pressure of Carbon Dioxide (CO2) in Arterial, Venous or Capillary Blood)	After one hour of ventilator use	Comparable level of gas exchange (measured as partial pressure of CO2 in arterial, venous or capillary blood)

Secondary Outcome Measures

Name	Time	Method
Heart Rate	60 minutes	heart rate as measured by beats per minute
Minute Ventilation	60 minutes	Minute ventilation
Tidal Volume	60 minutes	Tidal Volume

Trial Locations

Locations (1)

University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada