NCT00810459

Trilogy Comparison Study - Pediatrics

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Philips Respironics · Industry
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Respiratory Failure

Interventions

Type	Name	Description
DEVICE	Trilogy Ventilator	Exposure to one hour on the Trilog ventilator
DEVICE	Standard of Care	Exposure of one hour on the Participants prescribed ventilator

Timeline

• Start date: 2008-03-10
• Primary completion: 2009-01-26
• Completion: 2009-01-26
• First posted: 2008-12-18
• Last updated: 2021-02-03
• Results posted: 2021-02-03

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study