Respiratory InsufficiencyNCT00810498

Trilogy Comparison Study - Adults

A study testing Trilogy in people with Respiratory Insufficiency and Respiratory Failure, run by Philips Respironics at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 21 to 85 years
Conditions the study is for: Respiratory Insufficiency, Respiratory Failure
What is being tested?: Trilogy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteCanada
Study dates: 12 Mar 2008to 5 Feb 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

University of Manitoba
Winnipeg, Manitoba, R3E 0Z3

Other trials in Canada

About this study

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

Read the detailed description

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.
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
Being tested: Trilogy, Standard of Care
Medical subject headings: Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TrilogyDevice
Exposure for one hour on the Trilogy ventilator
Standard of CareDevice
Exposure to participants current ventilator

Study groups in NCT00810498
Study group	Role	What they receive
Trilogy	Experimental	Trilogy Device Receives: Device: Trilogy
Standard of Care	Active comparator	Participants prescribed ventilator Receives: Device: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: After one hour of ventilator use
Comparable Level of Gas Exchange SpO2 Levels During Various Modes of Ventilation.
Pulse Oximetry was measured after one hour of use of each ventilator.
Measured: After one hour of ventilator use

Secondary outcomes (3)

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.
Measured: One hour during ventilator use.
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.
Measured: One hour during ventilator use.
Hemodynamics (Heart Rate)
Number of beats per minute. Measured after one hour of use of each device.
Measured: One hour during ventilator use.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Mar 20085 Feb 2009

First posted18 Dec 2008 (estimated)
Study start12 Mar 2008
Primary completion5 Feb 2009
Study completion5 Feb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00810498
Sponsor's protocol ID: MR-0609-TRI2-SS
Status last verified: Aug 2026
First submitted: 17 Dec 2008
Last updated: 21 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Diaphragm Response in Elderly for Acute Monitoring
Acute Dyspnea, Acute Respiratory Failure
Not yet recruiting
Modified Inhaled Nitric Oxide in Ventilated Patients With Acute Respiratory Failure
Acute Respiratory Failure (ARF), Nitric Oxide
RecruitingObservational study
Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
Brief Resolved Unexplained Event, Apparent Life Threatening Event
Recruiting
Platform of Randomized Adaptive Clinical Trials in Critical Illness
Respiratory Insufficiency, Extracorporeal Membrane Oxygenation Complication
Active, not recruitingObservational study
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure

All Respiratory Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparing Known Modes of Ventilation Delivered by Trilogy Versus Conventional Mechanical Ventilators
ClinicalTrials.gov ID: NCT00810498
Acronym / sponsor ID: MR-0609-TRI2-SS
Conditions: Respiratory Insufficiency, Respiratory Failure
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Philips RespironicsIndustry (pharma, biotech, devices)
Study start: 12 Mar 2008 (actual)
Primary completion: 5 Feb 2009 (actual)
Study completion: 5 Feb 2009 (actual)
First posted: 18 Dec 2008 (estimated)
Results: Posted 3 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.
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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Trilogy	Experimental	Device: TrilogyTrilogy Device
Standard of Care	Active comparator	Device: Standard of CareParticipants prescribed ventilator

Who may qualify

Ages: 21 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (7 listed)

Clinically unstable, i.e.,
Patients suffering from metastatic or terminal cancer and patients with do-not-resuscitate orders
Pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TrilogyExposure for one hour on the Trilogy ventilator	Device	Trilogy
Standard of CareExposure to participants current ventilator	Device	Standard of Care

Primary outcome

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.
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.

3 secondary outcomes

Tidal Volume
Time frame: One hour during ventilator use.
Minute Ventilation
Time frame: One hour during ventilator use.
Hemodynamics (Heart Rate)
Time frame: One hour during ventilator use.

Results and safety

Results posted to the registry on 3 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Trilogy First, Then Standard of Care	6	6
Standard of Care First, Then Trilogy	5	5

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

Time frame: After one hour of ventilator use. Mean (Standard Deviation). Unit: mm Hg

Measure	Trilogy n = 10	Standard of Care n = 10
Value	42 (14)	43 (14)

Population analysed: Only 10 out of 11 total participants' data were used for blood gases due to one participant's venous line occluding.

Primary outcome: Comparable Level of Gas Exchange SpO2 Levels During Various Modes of Ventilation.

Time frame: After one hour of ventilator use. Mean (Standard Deviation). Unit: mm Hg

Measure	Trilogy n = 10	Standard of Care n = 8
Value	98 (2)	97 (2)

Population analysed: Only 10 out of the 11 total participants' data were used for SpO2 due to missing data. Only 8 out of the 11 total participants data were used for SpO2 Standard of care analysis due to missing data.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Trilogy Device	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Standard of Care	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Respiratory Insufficiency

Not yet recruitingObservational study
Diaphragm Response in Elderly for Acute Monitoring
Acute Dyspnea, Acute Respiratory Failure
Not yet recruiting
Modified Inhaled Nitric Oxide in Ventilated Patients With Acute Respiratory Failure
Acute Respiratory Failure (ARF), Nitric Oxide
RecruitingObservational study
Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
Brief Resolved Unexplained Event, Apparent Life Threatening Event
Recruiting
Platform of Randomized Adaptive Clinical Trials in Critical Illness
Respiratory Insufficiency, Extracorporeal Membrane Oxygenation Complication
Active, not recruitingObservational study
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steven Mink, MD principal investigator

University of Manitoba

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Trilogy in people with Respiratory Insufficiency and Respiratory Failure, run by Philips Respironics at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparable Level of Gas Exchange (Measured as Partial Pressure of CO2 in Arterial or Venous Blood). (time frame: After one hour of ventilator use). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00810498.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.