Trial Outcomes & Findings for Assessment of Limb Perfusion During Junctional Tourniquet (NCT NCT02092415)
NCT ID: NCT02092415
Last Updated: 2015-05-29
Results Overview
Contrast ultrasound perfusion imaging will be performed at baseline and 1 min after application of the JT.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
baseline and 1 min post occlusion
Results posted on
2015-05-29
Participant Flow
Participant milestones
| Measure |
Normal Subjects
Normal subjects, all of whom undergo brief application of junctional tourniquet
Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Limb Perfusion During Junctional Tourniquet
Baseline characteristics by cohort
| Measure |
Normal Subjects
n=10 Participants
Normal subjects, all of whom undergo brief application of junctional tourniquet
Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: baseline and 1 min post occlusionContrast ultrasound perfusion imaging will be performed at baseline and 1 min after application of the JT.
Outcome measures
| Measure |
Normal Subjects Baseline Flow
n=10 Participants
Normal subjects, all of whom undergo brief application of junctional tourniquet
Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery.
|
Normal Subjects - Tourniquet Flow
n=10 Participants
Perfusion measured at time of tourniquet placement
|
|---|---|---|
|
Muscle Perfusion
|
0.32 IU/s
Standard Error 0.10
|
0.10 IU/s
Standard Error 0.03
|
Adverse Events
Normal Subjects
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