Trial Outcomes & Findings for Engineering Evaluation of the Helix Ventilator (NCT NCT03613363)

NCT ID: NCT03613363

Last Updated: 2025-06-06

Results Overview

Proximal pressure from the participant's Trilogy Evo ventilator and current device

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

1 day

Results posted on

2025-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	Helix Ventilator The Helix ventilator is a non-FDA cleared ventilator device. The Helix ventilator has similar modalities to the Trilogy ventilator, which has FDA clearance. The Helix device has improved algorithms, controls, and features to enhance the therapy delivery. Additionally, Helix has an updated hardware platform which has been adequately tested to ensure that the device specifications are met. No pre-clinical or developmental clinical work was required because of Trilogy being the established predicate. Helix Ventilator: The Helix ventilator is a non-FDA cleared ventilator device. The Helix ventilator has similar modalities to the Trilogy ventilator, which has FDA clearance. The Helix device has improved algorithms, controls, and features to enhance the therapy delivery. Additionally, Helix has an updated hardware platform which has been adequately tested to ensure that the device specifications are met. No pre-clinical or developmental clinical work was required because of Trilogy being the established predicate.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Engineering Evaluation of the Helix Ventilator

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Evaluable Population n=13 Participants This population of non-invasive patients completed the engineering evaluation and utilized settings that allowed proper comparison between Trilogy and their current ventilator.	Non-Evaluable Population n=7 Participants This population included N=2 invasive-ventilator patients, as well as N=1 who did not complete the engineering evaluation, and N=4 who were only included for the purposes of testing the updated leak algorithm.	Total n=20 Participants Total of all reporting groups
Age, Continuous	11.3 years STANDARD_DEVIATION 10.2 • n=5 Participants	16.3 years STANDARD_DEVIATION 8.5 • n=7 Participants	13.1 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	7 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: This population of non-invasive patients completed the engineering evaluation and utilized settings that allowed proper comparison between Trilogy and their current ventilator. It excludes N=2 invasive-ventilator patients, as well as N=1 who did not complete the engineering evaluation, and N=4 who were only included for the purposes of testing the updated leak algorithm.

Proximal pressure from the participant's Trilogy Evo ventilator and current device

Outcome measures

Outcome measures
Measure	Evaluable Population: Trilogy Evo n=13 Participants Proximal Pressure (cm H2O) while on Trilogy Evo therapy	Evaluable Population: Current Device n=13 Participants Proximal Pressure (cm H2O) while using current device
Proximal Pressure From Trilogy Evo Ventilator and Current Device	8.3 cm H2O Standard Deviation 1.6	8.2 cm H2O Standard Deviation 3.0

PRIMARY outcome

Timeframe: 1 day

Proximal flow from Trilogy Evo and patient's current device

Outcome measures

Outcome measures
Measure	Evaluable Population: Trilogy Evo n=13 Participants Proximal Pressure (cm H2O) while on Trilogy Evo therapy	Evaluable Population: Current Device n=13 Participants Proximal Pressure (cm H2O) while using current device
Proximal Flow From Trilogy Evo and Patient's Current Device	4.2 Liters / minute Standard Deviation 4.5	4.9 Liters / minute Standard Deviation 5.7

SECONDARY outcome

Timeframe: 1 day

Subjective Ease-of-Operation rating (1-Very Easy to 5-Very Hard) regarding Trilogy device

Outcome measures

Outcome measures
Measure	Evaluable Population: Trilogy Evo n=12 Participants Proximal Pressure (cm H2O) while on Trilogy Evo therapy	Evaluable Population: Current Device Proximal Pressure (cm H2O) while using current device
Subjective Ease-of-Operation Rating Regarding Trilogy Device	1.9 scores on a scale Standard Deviation 0.8	—

Adverse Events

Helix 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

Chuck Cain

Philips

Phone: 412-657-1814

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place