NCT00810498

Trilogy Comparison Study - Adults

Comparing Known Modes of Ventilation Delivered by Trilogy Versus Conventional Mechanical Ventilators

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Philips Respironics · Industry
• Sex: All
• Age: 21 Years – 85 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 CO2 in arterial or venous blood)and 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 Insufficiency
• Respiratory Failure

Interventions

Type	Name	Description
DEVICE	Trilogy	Exposure for one hour on the Trilogy ventilator
DEVICE	Standard of Care	Exposure to participants current ventilator

Timeline

• Start date: 2008-03-12
• Primary completion: 2009-02-05
• Completion: 2009-02-05
• 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