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Completed

NCT Number: NCT00810498

Trilogy Comparison Study - Adults

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.

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Key information

Conditions

Respiratory Insufficiency Respiration Disorders Respiratory Failure Respiratory Tract Diseases

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Manitoba

Winnipeg, Manitoba, R3E 0Z3, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 21 years of age; < 85 years of age
  • Able to follow instructions
  • Able to provide informed consent
  • 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.
  • Requiring mechanical ventilation through nasal/facial mask,tracheostomy or endotracheal tube (ET Tube)

Exclusion criteria

  • Clinically unstable, i.e.,
  • Acute Respiratory Failure
  • Participants with refractory hypotension defined as systolic blood pressure less than 90 mm Hg despite inotropic agents),
  • Uncontrolled cardiac ischemia or arrhythmias,
  • or as otherwise determined inappropriate for the study as determined by the investigator.
  • Patients suffering from metastatic or terminal cancer and patients with do-not-resuscitate orders
  • Pregnancy

Treatment and study plan

Trilogy

Device

Exposure for one hour on the Trilogy ventilator

Standard of care

Device

Exposure to participants current ventilator

Primary outcomes

  1. Comparable Level of Gas Exchange (Measured as Partial Pressure of CO2 in Arterial or Venous Blood).

    Time frame: After one hour of ventilator use

    Blood gas was obtained for this study one hour after use of each device.

  2. Comparable Level of Gas Exchange SpO2 Levels During Various Modes of Ventilation.

    Time frame: After one hour of ventilator use

    Pulse Oximetry was measured after one hour of use of each ventilator.

Secondary outcomes

  1. Tidal Volume

    Time frame: One hour during ventilator use.

    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.

  2. Minute Ventilation

    Time frame: One hour during ventilator use.

    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.

  3. Hemodynamics (Heart Rate)

    Time frame: One hour during ventilator use.

    Number of beats per minute. Measured after one hour of use of each device.

Sponsors and collaborators

Lead sponsor

Philips Respironics

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 18, 2008
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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