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
COMPLETED
NA
20 participants
1 day
2025-06-06
Participant Flow
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
| 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=99 Participants
|
16.3 years
STANDARD_DEVIATION 8.5 • n=107 Participants
|
13.1 years
STANDARD_DEVIATION 9.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
7 participants
n=107 Participants
|
20 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: 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
| 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 dayPopulation: 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 flow from Trilogy Evo and patient's current device
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 dayPopulation: 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. Data not available from N=1 participant.
Subjective Ease-of-Operation rating (1-Very Easy to 5-Very Hard) regarding Trilogy device
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 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