An interventional study of Trilogy Ventilator and Standard of Care in Respiratory Failure, sponsored by Philips Respironics. Completed at 1 site in Canada. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2021-02-03.
Sponsored by Philips Respironics · Not applicable, Interventional, and Treatment
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.
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 carbon dioxide (CO2) in arterial, venous or capillary blood)and peripheral capillary oxygen saturation, (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).
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 6 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Philips Respironics is the lead sponsor of 40 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Clinically unstable, i.e.,
Trilogy ventilator
Device: Trilogy Ventilator
Participants currently prescribed ventilator
Device: Standard of Care
Exposure to one hour on the Trilog ventilator
Exposure of one hour on the Participants prescribed ventilator
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)
Time frame: 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
Time frame: After one hour of ventilator use
Heart Rate
heart rate as measured by beats per minute
Time frame: 60 minutes
Minute Ventilation
Minute ventilation
Time frame: 60 minutes
Tidal Volume
Tidal Volume
Time frame: 60 minutes
One participant was reconsented to complete the assessment on new software, this participants was not counted twice in the demographics or protocol enrollment.
| Milestone | Trilogy Ventilator First, Then Standard of Care Ventilator | Standard of Care Ventilator First, Then Trilogy Ventilator |
|---|---|---|
| Started | 4 | 2 |
| Completed | 4 | 2 |
| Not completed | 0 | 0 |
Comparable level of gas exchange (measured as partial pressure of CO2 in arterial, venous or capillary blood)
| mEq/L | Trilogy Ventilator | Standard of Care |
|---|---|---|
| Comparable Level of Gas Exchange (Measured as Partial Pressure of Carbon Dioxide (CO2) in Arterial, Venous or Capillary Blood) | 37 ± 7.5 | 33.3 ± 11.9 |
Comparable level of gas exchange for SpO\^2
| mmHg | Trilogy Ventilator | Standard of Care |
|---|---|---|
| Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2) | 94.6 ± 4.0 | 97.0 ± 1.9 |
heart rate as measured by beats per minute
| bpm | Trilogy Ventilator | Standard of Care |
|---|---|---|
| Heart Rate | 114.5 ± 26.4 | 103.8 ± 18.1 |
Minute ventilation
| Lpm | Trilogy Ventilator | Standard of Care |
|---|---|---|
| Minute Ventilation | 4.9 ± 2.25 | 5.3 ± 3.2 |
Tidal Volume
| mL/kg | Trilogy Ventilator | Standard of Care |
|---|---|---|
| Tidal Volume | 239 ± 221 | 226 ± 209 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Trilogy Ventilator | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Standard of Care Ventilator | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Continuous(years) | All Participants Consented |
|---|---|
| Mean | 7.2 ± 6.4 |
| Sex: Female, Male(Participants) | All Participants Consented |
|---|---|
| Female | 1 |
| Male | 5 |
| Race (NIH/OMB)(Participants) | All Participants Consented |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 1 |
| More than one race | 0 |
| Unknown or Not Reported | 5 |
| Region of Enrollment(participants) | All Participants Consented |
|---|---|
| Canada | 6 |
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Philips Respironics