Respiratory FailureNCT00810459
Trilogy Comparison Study - Pediatrics
A study testing Trilogy Ventilator in people with Respiratory Failure, run by Philips Respironics at 1 site in Canada.
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 1 year to 18 years
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Trilogy Ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 10 Mar 2008to 26 Jan 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age > 1years of age; < 18 years of age
- Greater than 5 kg
- 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.
About this study
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 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 carbon dioxide (CO2) in arterial, venous or capillary blood)and peripheral capillary oxygen saturation, (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 Failure
- Being tested
- Trilogy Ventilator, 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.
Trilogy VentilatorDevice
Exposure to one hour on the Trilog ventilator
Standard of CareDevice
Exposure of one hour on the Participants prescribed ventilator
| Study group | Role | What they receive |
|---|---|---|
| Trilogy ventilator | Experimental | Trilogy ventilator Receives: Device: Trilogy Ventilator |
| Standard of Care | Active comparator | Participants currently 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 Carbon Dioxide (CO2) in Arterial, Venous or Capillary Blood)
Comparable level of gas exchange (measured as partial pressure of CO2 in arterial, venous or capillary blood)
Measured: After one hour of ventilator use
Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2)
Comparable level of gas exchange for SpO^2
Measured: After one hour of ventilator use
Secondary outcomes (3)
Heart Rate
heart rate as measured by beats per minute
Measured: 60 minutes
Minute Ventilation
Minute ventilation
Measured: 60 minutes
Tidal Volume
Tidal Volume
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study start10 Mar 2008
- Primary completion26 Jan 2009
- Study completion26 Jan 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 FailureStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Mink, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810459
- Sponsor's protocol ID
- MR-0713-PTRI-SS
- Status last verified
- Jan 2021
- First submitted
- 17 Dec 2008
- Last updated
- 3 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trilogy Comparison Study - Pediatrics
- ClinicalTrials.gov ID
- NCT00810459
- Acronym / sponsor ID
- MR-0713-PTRI-SS
- Conditions
- Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2008 (actual)
- Primary completion
- 26 Jan 2009 (actual)
- Study completion
- 26 Jan 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.
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
- 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.
- 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 ventilator | Experimental | Device: Trilogy VentilatorTrilogy ventilator |
| Standard of Care | Active comparator | Device: Standard of CareParticipants currently prescribed ventilator |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age > 1years of age; < 18 years of age
- Greater than 5 kg
- 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 |
|---|---|---|
| Trilogy VentilatorExposure to one hour on the Trilog ventilator | Device | Trilogy ventilator |
| Standard of CareExposure of one hour on the Participants prescribed ventilator | Device | Standard of Care |
Primary outcome
Comparable Level of Gas Exchange (Measured as Partial Pressure of Carbon Dioxide (CO2) in Arterial, Venous or Capillary Blood)
Time frame: After one hour of ventilator use
Comparable level of gas exchange (measured as partial pressure of CO2 in arterial, venous or capillary blood)
Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2)
Time frame: After one hour of ventilator use
Comparable level of gas exchange for SpO^2
3 secondary outcomes
Heart Rate
Time frame: 60 minutes
Minute Ventilation
Time frame: 60 minutes
Tidal Volume
Time frame: 60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Respiratory Failure
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Impact of Inspiratory Effort and Patient-Ventilator Interaction During the Transition Phase
Mechanically Ventilated Patients, Acute Respiratory Failure (ARF)
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Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
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Humidification Effects on Airway Complications and Clinical Outcomes in Trauma ICU Patients on Mechanical Ventilation
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Clinical Genetics Branch Eligibility Screening Survey
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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 Ventilator in people with 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 4 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 3 Feb 2021. 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 Carbon Dioxide (CO2) in Arterial, Venous or Capillary 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?
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 3 Feb 2021.