Trilogy Comparison Study - Adults

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00810498
• Other study ID #: MR-0609-TRI2-SS
• Status: Completed
• Phase: N/A
• Start date: March 12, 2008
• Est. completion date: February 5, 2009

Study information

• Verified date: January 2021
• Source: Philips Respironics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 5, 2009
• Est. primary completion date: February 5, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Age > 21 years of age; < 85 years of age

2. Able to follow instructions

3. Able to provide informed consent

4. 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.

5. 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

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Trilogy
Exposure for one hour on the Trilogy ventilator
• Standard of Care
Exposure to participants current ventilator

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Philips Respironics

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparable Level of Gas Exchange (Measured as Partial Pressure of CO2 in Arterial or Venous Blood).	Blood gas was obtained for this study one hour after use of each device.	After one hour of ventilator use
Primary	Comparable Level of Gas Exchange SpO2 Levels During Various Modes of Ventilation.	Pulse Oximetry was measured after one hour of use of each ventilator.	After one hour of ventilator use
Secondary	Tidal Volume	Tidal volume is the amount of air that moves in or out of the lungs with each respiratory cycle. It measures around 500 mL in an average healthy adult male and approximately 400 mL in a healthy female. Average tidal volume was compare after a hour of use of each device.	One hour during ventilator use.
Secondary	Minute Ventilation	Minute ventilation is the volume of gas inhaled or exhaled from a person's lungs per minute. This was measured after one hour of use of each device.	One hour during ventilator use.
Secondary	Hemodynamics (Heart Rate)	Number of beats per minute. Measured after one hour of use of each device.	One hour during ventilator use.