Trial Outcomes & Findings for Trilogy Comparison Study - Adults (NCT NCT00810498)

NCT ID: NCT00810498

Last Updated: 2021-02-03

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: After one hour of ventilator use
• Results posted on: 2021-02-03

Participant Flow

Participant milestones

Measure	Trilogy First, Then Standard of Care These participants used Trilogy first, then Standard of Care.	Standard of Care First, Then Trilogy these participants used Standard of Care first, then Trilogy.
Overall Study STARTED	6	5
Overall Study COMPLETED	6	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trilogy Comparison Study - Adults

Baseline characteristics by cohort

Measure	All Participants Consented n=11 Participants All participants that were consented.
Age, Continuous	57.8 years STANDARD_DEVIATION 8.82 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment Canada	11 participants n=5 Participants

PRIMARY outcome

Timeframe: After one hour of ventilator use

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

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

Outcome measures

Measure	Trilogy n=10 Participants Trilogy Device Trilogy: Exposure for one hour on the Trilogy ventilator	Standard of Care n=10 Participants Participants prescribed ventilator Standard of Care: Exposure to participants current ventilator
Comparable Level of Gas Exchange (Measured as Partial Pressure of CO2 in Arterial or Venous Blood).	42 mm Hg Standard Deviation 14	43 mm Hg Standard Deviation 14

PRIMARY outcome

Timeframe: After one hour of ventilator use

Population: 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.

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

Outcome measures

Measure	Trilogy n=10 Participants Trilogy Device Trilogy: Exposure for one hour on the Trilogy ventilator	Standard of Care n=8 Participants Participants prescribed ventilator Standard of Care: Exposure to participants current ventilator
Comparable Level of Gas Exchange SpO2 Levels During Various Modes of Ventilation.	98 mm Hg Standard Deviation 2	97 mm Hg Standard Deviation 2

SECONDARY outcome

Timeframe: One hour during ventilator use.

Population: Missing one data set for Standard of care.

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.

Outcome measures

Measure	Trilogy n=11 Participants Trilogy Device Trilogy: Exposure for one hour on the Trilogy ventilator	Standard of Care n=10 Participants Participants prescribed ventilator Standard of Care: Exposure to participants current ventilator
Tidal Volume	479 mL/kg Standard Deviation 182	498 mL/kg Standard Deviation 128

SECONDARY outcome

Timeframe: One hour during ventilator use.

Population: Missing one data set for Standard of Care.

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.

Outcome measures

Measure	Trilogy n=11 Participants Trilogy Device Trilogy: Exposure for one hour on the Trilogy ventilator	Standard of Care n=10 Participants Participants prescribed ventilator Standard of Care: Exposure to participants current ventilator
Minute Ventilation	10.11 L/m Standard Deviation 1.94	10.11 L/m Standard Deviation 2.12

SECONDARY outcome

Timeframe: One hour during ventilator use.

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

Outcome measures

Measure	Trilogy n=11 Participants Trilogy Device Trilogy: Exposure for one hour on the Trilogy ventilator	Standard of Care n=11 Participants Participants prescribed ventilator Standard of Care: Exposure to participants current ventilator
Hemodynamics (Heart Rate)	89.9 beats per minute Standard Deviation 19.0	90.4 beats per minute Standard Deviation 19.7

Adverse Events

Trilogy Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

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

Jeff Jasko

Philips

Phone: 412-542-3651

Email: jeff.jasko@philips.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place