Trial Outcomes & Findings for Trilogy Comparison Study - Pediatrics (NCT NCT00810459)
NCT ID: NCT00810459
Last Updated: 2021-02-03
Results Overview
Comparable level of gas exchange (measured as partial pressure of CO2 in arterial, venous or capillary blood)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
After one hour of ventilator use
Results posted on
2021-02-03
Participant Flow
One participant was reconsented to complete the assessment on new software, this participants was not counted twice in the demographics or protocol enrollment.
Participant milestones
| Measure |
Trilogy Ventilator First, Then Standard of Care Ventilator
These participants used the Trilogy Ventilator first, then Standard of Care Ventilator
|
Standard of Care Ventilator First, Then Trilogy Ventilator
Theses participants used the Standard of Care Ventilator first and then Trilogy Ventilator.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
|
Overall Study
COMPLETED
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trilogy Comparison Study - Pediatrics
Baseline characteristics by cohort
| Measure |
All Participants Consented
n=6 Participants
All participants consented for the study.
|
|---|---|
|
Age, Continuous
|
7.2 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After one hour of ventilator useComparable level of gas exchange (measured as partial pressure of CO2 in arterial, venous or capillary blood)
Outcome measures
| Measure |
Trilogy Ventilator
n=6 Participants
Trilogy ventilator
Trilogy Ventilator: Exposure to one hour on the Trilogy ventilator
|
Standard of Care
n=6 Participants
Participants currently prescribed ventilator
Standard of Care: 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)
|
37 mEq/L
Standard Deviation 7.5
|
33.3 mEq/L
Standard Deviation 11.9
|
PRIMARY outcome
Timeframe: After one hour of ventilator useComparable level of gas exchange for SpO\^2
Outcome measures
| Measure |
Trilogy Ventilator
n=6 Participants
Trilogy ventilator
Trilogy Ventilator: Exposure to one hour on the Trilogy ventilator
|
Standard of Care
n=6 Participants
Participants currently prescribed ventilator
Standard of Care: Exposure of one hour on the Participants prescribed ventilator
|
|---|---|---|
|
Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2)
|
94.6 mmHg
Standard Deviation 4.0
|
97.0 mmHg
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 60 minutesheart rate as measured by beats per minute
Outcome measures
| Measure |
Trilogy Ventilator
n=6 Participants
Trilogy ventilator
Trilogy Ventilator: Exposure to one hour on the Trilogy ventilator
|
Standard of Care
n=6 Participants
Participants currently prescribed ventilator
Standard of Care: Exposure of one hour on the Participants prescribed ventilator
|
|---|---|---|
|
Heart Rate
|
114.5 bpm
Standard Deviation 26.4
|
103.8 bpm
Standard Deviation 18.1
|
SECONDARY outcome
Timeframe: 60 minutesPopulation: One data point not captured
Minute ventilation
Outcome measures
| Measure |
Trilogy Ventilator
n=5 Participants
Trilogy ventilator
Trilogy Ventilator: Exposure to one hour on the Trilogy ventilator
|
Standard of Care
n=6 Participants
Participants currently prescribed ventilator
Standard of Care: Exposure of one hour on the Participants prescribed ventilator
|
|---|---|---|
|
Minute Ventilation
|
4.9 Lpm
Standard Deviation 2.25
|
5.3 Lpm
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 60 minutesPopulation: One data point not captured for a participant
Tidal Volume
Outcome measures
| Measure |
Trilogy Ventilator
n=5 Participants
Trilogy ventilator
Trilogy Ventilator: Exposure to one hour on the Trilogy ventilator
|
Standard of Care
n=6 Participants
Participants currently prescribed ventilator
Standard of Care: Exposure of one hour on the Participants prescribed ventilator
|
|---|---|---|
|
Tidal Volume
|
239 mL/kg
Standard Deviation 221
|
226 mL/kg
Standard Deviation 209
|
Adverse Events
Trilogy Ventilator
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care Ventilator
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place