Trial Outcomes & Findings for The Intrepid Clinical Engineering Study (NCT NCT05636332)
NCT ID: NCT05636332
Last Updated: 2024-03-25
Results Overview
Number of participants with failure to obtain a 12-lead Electrocardiogram (ECG) with the Philips HeartStart Intrepid Monitor/Defibrillator.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
day 1
Results posted on
2024-03-25
Participant Flow
Participant milestones
| Measure |
New Electrodes
Unopened package of Electrodes will be applied to participants.
|
24-hour Opened Electrodes
Package of Electrodes will be opened 24- hour before applied to participants.
|
30 Day Opened Electrodes.
Package of Electrodes will be opened 30 day (plus or minus 10 days) before applied to participants.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Intrepid Clinical Engineering Study
Baseline characteristics by cohort
| Measure |
New Electrodes
n=20 Participants
Unopened package of Electrodes will be applied to participants.
|
24-hour Opened Electrodes
n=20 Participants
Package of Electrodes will be opened 24- hour before applied to participants.
|
30 Day Opened Electrodes
n=20 Participants
Package of Electrodes will be opened 30 day (plus or minus 10 days) before applied to participants.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
24.9 years
STANDARD_DEVIATION 18.3 • n=5 Participants
|
31.8 years
STANDARD_DEVIATION 19.4 • n=7 Participants
|
24.5 years
STANDARD_DEVIATION 17.0 • n=5 Participants
|
27.0 years
STANDARD_DEVIATION 18.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Cuban
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mexican
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Puerto Rican
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown or not reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
Weight
|
137.2 pounds
STANDARD_DEVIATION 65.5 • n=5 Participants
|
160.3 pounds
STANDARD_DEVIATION 54.5 • n=7 Participants
|
141.1 pounds
STANDARD_DEVIATION 74.6 • n=5 Participants
|
146.2 pounds
STANDARD_DEVIATION 65.1 • n=4 Participants
|
|
Height
|
58.7 inches
STANDARD_DEVIATION 14.3 • n=5 Participants
|
61.6 inches
STANDARD_DEVIATION 9.2 • n=7 Participants
|
56.1 inches
STANDARD_DEVIATION 12.1 • n=5 Participants
|
58.8 inches
STANDARD_DEVIATION 12.0 • n=4 Participants
|
|
Body Mass Index (BMI)
|
25.4 kg/m^2
STANDARD_DEVIATION 6.1 • n=5 Participants
|
29.4 kg/m^2
STANDARD_DEVIATION 8.2 • n=7 Participants
|
29.0 kg/m^2
STANDARD_DEVIATION 11.1 • n=5 Participants
|
27.9 kg/m^2
STANDARD_DEVIATION 8.8 • n=4 Participants
|
|
Melanin Index
|
215.9 units on a scale
STANDARD_DEVIATION 93.6 • n=5 Participants
|
253.8 units on a scale
STANDARD_DEVIATION 96.1 • n=7 Participants
|
226.5 units on a scale
STANDARD_DEVIATION 62.6 • n=5 Participants
|
232.0 units on a scale
STANDARD_DEVIATION 85.5 • n=4 Participants
|
|
Erythema Index
|
275.8 units on a scale
STANDARD_DEVIATION 94.5 • n=5 Participants
|
316.8 units on a scale
STANDARD_DEVIATION 81.4 • n=7 Participants
|
284.7 units on a scale
STANDARD_DEVIATION 56.0 • n=5 Participants
|
292.4 units on a scale
STANDARD_DEVIATION 79.6 • n=4 Participants
|
|
Skin Temperature
Hot
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Skin Temperature
Warm-Normal
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Skin Temperature
Cool
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Skin Temperature
Cold
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Skin Moisture
Excessively Dry
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Skin Moisture
Dry
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Skin Texture
Smooth
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Skin Texture
Rough
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Skin Texture
Soft
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Skin Texture
Firm
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Other observations: (Pallor, Jaundiced, Mottled, Cyanotic, etc.)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: day 1Number of participants with failure to obtain a 12-lead Electrocardiogram (ECG) with the Philips HeartStart Intrepid Monitor/Defibrillator.
Outcome measures
| Measure |
New Electrodes
n=20 Participants
Unopened package of Electrodes will be applied to participants.
|
24-hour Opened Electrodes
n=20 Participants
Package of Electrodes will be opened 24- hour before applied to participants.
|
30 Day Opened Electrodes
n=20 Participants
Package of Electrodes will be opened 30 day (plus or minus 10 days) before applied to participants.
|
|---|---|---|---|
|
Validation of Algorithm Software Update
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: day 1Number of participants with diagnostic quality 12-lead ECG tracings from the Philips HeartStart Intrepid Monitor/Defibrillator.
Outcome measures
| Measure |
New Electrodes
n=20 Participants
Unopened package of Electrodes will be applied to participants.
|
24-hour Opened Electrodes
n=20 Participants
Package of Electrodes will be opened 24- hour before applied to participants.
|
30 Day Opened Electrodes
n=20 Participants
Package of Electrodes will be opened 30 day (plus or minus 10 days) before applied to participants.
|
|---|---|---|---|
|
Diagnostic Quality
|
20 Participants
|
20 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: day 1Participants with frequency and severity of unexpected adverse events
Outcome measures
| Measure |
New Electrodes
n=20 Participants
Unopened package of Electrodes will be applied to participants.
|
24-hour Opened Electrodes
n=20 Participants
Package of Electrodes will be opened 24- hour before applied to participants.
|
30 Day Opened Electrodes
n=20 Participants
Package of Electrodes will be opened 30 day (plus or minus 10 days) before applied to participants.
|
|---|---|---|---|
|
Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: day 1Participants with unanticipated adverse device effects (UADE).
Outcome measures
| Measure |
New Electrodes
n=20 Participants
Unopened package of Electrodes will be applied to participants.
|
24-hour Opened Electrodes
n=20 Participants
Package of Electrodes will be opened 24- hour before applied to participants.
|
30 Day Opened Electrodes
n=20 Participants
Package of Electrodes will be opened 30 day (plus or minus 10 days) before applied to participants.
|
|---|---|---|---|
|
Unanticipated Adverse Device Effects (UADE)
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
New Electrodes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
24-hour Opened Electrodes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
30 Day Opened Electrodes
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