Trial Outcomes & Findings for Sex and Age Ultrasound Response to Differential Jugular Vein Pressure (NCT NCT03017937)
NCT ID: NCT03017937
Last Updated: 2020-11-17
Results Overview
measurement of the neck collar size at each pressure level
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
155 participants
Primary outcome timeframe
1 hour
Results posted on
2020-11-17
Participant Flow
Participant milestones
| Measure |
Q- Collar
All subjects will wear 3 sizes of the q-collar and ultrasound images of the jugular vein will be measured with each collar. Also, each subject will wear a pressure collar and ultrasound images of the jugular vein will be captured at each pressure point (0.1-0.5)
Q-collar: capture ultrasound images at each pressure point
|
|---|---|
|
Overall Study
STARTED
|
155
|
|
Overall Study
COMPLETED
|
155
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Q- Collar
n=155 Participants
All subjects will wear 3 sizes of the q-collar and ultrasound images of the jugular vein will be measured with each collar. Also, each subject will wear a pressure collar and ultrasound images of the jugular vein will be captured at each pressure point (0.1-0.5)
Q-collar: capture ultrasound images at each pressure point
|
|---|---|
|
Age, Continuous
|
28.8 years
STANDARD_DEVIATION 14.80 • n=155 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=155 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=155 Participants
|
|
Region of Enrollment
United States
|
155 participants
n=155 Participants
|
|
Average neck size
|
13.5 inches
STANDARD_DEVIATION 2.18 • n=155 Participants
|
PRIMARY outcome
Timeframe: 1 hourPopulation: analysis broken down by gender and collar size
measurement of the neck collar size at each pressure level
Outcome measures
| Measure |
Females
n=69 Participants
All subjects will wear 3 sizes of the q-collar and ultrasound images of the jugular vein will be measured with each collar. Also, each subject will wear a pressure collar and ultrasound images of the jugular vein will be captured at each pressure point (0.1-0.5)
Q-collar: capture ultrasound images at each pressure point
|
Males
n=86 Participants
All subjects will wear 3 sizes of the q-collar and ultrasound images of the jugular vein will be measured with each collar. Also, each subject will wear a pressure collar and ultrasound images of the jugular vein will be captured at each pressure point (0.1-0.5)
Q-collar: capture ultrasound images at each pressure point
|
|---|---|---|
|
Neck Collar Size
Size 14 1.25
|
14.167 inches
Standard Deviation 0.05
|
14.133 inches
Standard Deviation 0.05
|
|
Neck Collar Size
Size 11 0.75
|
11.15 inches
Standard Deviation 0.052
|
11.11 inches
Standard Deviation 0.032
|
|
Neck Collar Size
Size 11 1.0
|
11.25 inches
Standard Deviation 0.052
|
11.21 inches
Standard Deviation 0.032
|
|
Neck Collar Size
Size 11 1.25
|
11.145 inches
Standard Deviation 0.052
|
11.11 inches
Standard Deviation 0.032
|
|
Neck Collar Size
Size 12 0.75
|
12.25 inches
Standard Deviation 0.052
|
12.28 inches
Standard Deviation 0.044
|
|
Neck Collar Size
Size 12 1.0
|
12.25 inches
Standard Deviation 0.052
|
12.22 inches
Standard Deviation 0.044
|
|
Neck Collar Size
Size 12 1.25
|
12.25 inches
Standard Deviation 0.052
|
12.22 inches
Standard Deviation 0.044
|
|
Neck Collar Size
Size 13 0.75
|
13.18 inches
Standard Deviation 0.10
|
13.23 inches
Standard Deviation 0.1
|
|
Neck Collar Size
Size 13 1.0
|
13.18 inches
Standard Deviation 0.101
|
13.23 inches
Standard Deviation 0.1
|
|
Neck Collar Size
Size 13 1.25
|
13.24 inches
Standard Deviation 0.051
|
13.27 inches
Standard Deviation 0.05
|
|
Neck Collar Size
Size 14 0.75
|
14.133 inches
Standard Deviation 0.05
|
14.156 inches
Standard Deviation 0.053
|
|
Neck Collar Size
Size 14 1.0
|
14.133 inches
Standard Deviation 0.05
|
14.167 inches
Standard Deviation 0.05
|
|
Neck Collar Size
Size 15 0.75
|
15.15 inches
Standard Deviation 0.053
|
15.14 inches
Standard Deviation 0.051
|
|
Neck Collar Size
Size 15 1.0
|
15.2 inches
Standard Deviation 0.107
|
15.19 inches
Standard Deviation 0.103
|
|
Neck Collar Size
Size 15 1.25
|
15.15 inches
Standard Deviation 0.053
|
15.14 inches
Standard Deviation 0.051
|
|
Neck Collar Size
Size 16 0.75
|
16.26 inches
Standard Deviation 0.052
|
16.27 inches
Standard Deviation 0.05
|
|
Neck Collar Size
Size 16 1.0
|
16.24 inches
Standard Deviation 0.052
|
16.23 inches
Standard Deviation 0.05
|
|
Neck Collar Size
Size 16 1.25
|
16.23 inches
Standard Deviation 0.104
|
16.24 inches
Standard Deviation 0.1
|
|
Neck Collar Size
Size 17 0.75
|
17.1 inches
Standard Deviation 0
|
17.15 inches
Standard Deviation 0.052
|
|
Neck Collar Size
Size 17 1.0
|
17.2 inches
Standard Deviation 0
|
17.15 inches
Standard Deviation 0.052
|
|
Neck Collar Size
Size 17 1.25
|
17.3 inches
Standard Deviation 0
|
17.19 inches
Standard Deviation 0.10
|
|
Neck Collar Size
Size 18 0.75
|
—
|
18.15 inches
Standard Deviation 0.93
|
|
Neck Collar Size
Size 18 1.0
|
—
|
18.15 inches
Standard Deviation 0.093
|
|
Neck Collar Size
Size 18 1.25
|
—
|
18.13 inches
Standard Deviation 0.047
|
Adverse Events
Q- Collar
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