Trial Outcomes & Findings for A Transparent Elasticized Adhesive Occlusive Compression Bandage for Use as an Arterial Tourniquet (NCT NCT02592655)
NCT ID: NCT02592655
Last Updated: 2017-08-24
Results Overview
Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of a each tourniquet intervention to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered successful occlusion. A still image is then saved for later evaluation by the blinded outcome assessor. The 5 cm tape was discontinued after the 4th participant because the tape was considered to unacceptably narrow after stretching and this was considered a mechanical failure even if occlusion was observed. Therefore the 5 cm tape data was not evaluated by the radiologist.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
For 1 sustained minute after application of each tourniquet intervention.
Results posted on
2017-08-24
Participant Flow
Healthy volunteers with a minimum upper thigh circumference of 61 cm were recruited from the general population during the first two weeks of December 2015.
Each participant receives a different intervention each period. 19 Participants randomly allocated to unique sequences of four interventions. No participants were lost once enrolled. 5 minute minimum washout period between interventions.
Participant milestones
| Measure |
All Participants
Each subject has been randomly allocated to a sequence of interventions. Pneumatic tourniquet with a 10 cm (4 inch) wide cylindrical cuff typically used in surgical settings, and is representative of best outcome.
Windlass Tourniquet: The Special Operations Forces Tactical Tourniquet Wide (SOFTT-W) is 3.8 cm (1.5 inch) in width. The SOFTT-W is representative of the typical emergency tourniquet. In accordance with current prehospital guidelines: If a single windlass tourniquet not effective then a second windlass tourniquet will be applied immediately proximal to the first.
Tourniquet Tape 10 cm wide and Tourniquet Tape 5 cm wide are elastic adhesive tape tourniquets.
5 cm tape was discontinued after the 4th participant. Once stretched the tape was too narrow for sufficient overlap. Because the overlap was not sufficient the edges began to roll. This would create an unacceptably narrow band if left in place longer than the prescribed time.
|
|---|---|
|
First Tourniquet, Left Thigh.
STARTED
|
19
|
|
First Tourniquet, Left Thigh.
ATS (Pneumatic)
|
5
|
|
First Tourniquet, Left Thigh.
Windlass Tourniquet
|
7
|
|
First Tourniquet, Left Thigh.
Tourniquet Tape 10 cm Width
|
5
|
|
First Tourniquet, Left Thigh.
Tourniquet Tape 5 cm Width
|
2
|
|
First Tourniquet, Left Thigh.
COMPLETED
|
19
|
|
First Tourniquet, Left Thigh.
NOT COMPLETED
|
0
|
|
Second Tourniquet Right Thigh.
STARTED
|
19
|
|
Second Tourniquet Right Thigh.
ATS (Pneumatic)
|
5
|
|
Second Tourniquet Right Thigh.
Windlass Tourniquet
|
8
|
|
Second Tourniquet Right Thigh.
Tourniquet Tape 10 cm Width
|
5
|
|
Second Tourniquet Right Thigh.
Tourniquet Tape 5 cm Width
|
1
|
|
Second Tourniquet Right Thigh.
COMPLETED
|
19
|
|
Second Tourniquet Right Thigh.
NOT COMPLETED
|
0
|
|
Third Tourniquet, Left Thigh.
STARTED
|
19
|
|
Third Tourniquet, Left Thigh.
ATS (Pneumatic)
|
8
|
|
Third Tourniquet, Left Thigh.
Windlass Tourniquet
|
4
|
|
Third Tourniquet, Left Thigh.
Tourniquet Tape 10 cm Width
|
6
|
|
Third Tourniquet, Left Thigh.
Tourniquet Tape 5 cm Width
|
1
|
|
Third Tourniquet, Left Thigh.
COMPLETED
|
19
|
|
Third Tourniquet, Left Thigh.
NOT COMPLETED
|
0
|
|
Fourth Tourniquet Right Thigh.
STARTED
|
4
|
|
Fourth Tourniquet Right Thigh.
ATS (Pneumatic)
|
1
|
|
Fourth Tourniquet Right Thigh.
Windlass Tourniquet
|
0
|
|
Fourth Tourniquet Right Thigh.
Tourniquet Tape 10 cm Width
|
3
|
|
Fourth Tourniquet Right Thigh.
Tourniquet Tape 5 cm Width
|
0
|
|
Fourth Tourniquet Right Thigh.
COMPLETED
|
4
|
|
Fourth Tourniquet Right Thigh.
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Transparent Elasticized Adhesive Occlusive Compression Bandage for Use as an Arterial Tourniquet
Baseline characteristics by cohort
| Measure |
One Windlass Tourniquet
n=8 Participants
Baseline characteristics for participants that received only one windlass tourniquet.
|
Two Windlass Tourniquets
n=11 Participants
Baseline characteristics for participants who had a second windlass tourniquet applied immediately proximal to the first. Meaning that a single windlass tourniquet did not appear effective.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.5 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
36.1 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
33.7 years
STANDARD_DEVIATION 9.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
27.4 Kg/m^2
STANDARD_DEVIATION 1.7 • n=5 Participants
|
36.1 Kg/m^2
STANDARD_DEVIATION 4.3 • n=7 Participants
|
32.4 Kg/m^2
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
BMI Weight Status Category (CDC)
BMI 18.5 - 24.9 Normal
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
BMI Weight Status Category (CDC)
BMI 25.0 - 29.9 Overweight
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
BMI Weight Status Category (CDC)
BMI 30.0 and Above Obese
|
0 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Weight
|
87.5 kg
STANDARD_DEVIATION 11.0 • n=5 Participants
|
111.3 kg
STANDARD_DEVIATION 21.5 • n=7 Participants
|
101.25 kg
STANDARD_DEVIATION 21.22 • n=5 Participants
|
|
Height
|
178.6 cm
STANDARD_DEVIATION 9.7 • n=5 Participants
|
175.0 cm
STANDARD_DEVIATION 10.1 • n=7 Participants
|
176.5 cm
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Thigh Circumference
Upper Thigh
|
63.5 cm
STANDARD_DEVIATION 3.7 • n=5 Participants
|
71.2 cm
STANDARD_DEVIATION 5.9 • n=7 Participants
|
68.0 cm
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Thigh Circumference
10 cm above Mid Thigh
|
61.0 cm
STANDARD_DEVIATION 4.0 • n=5 Participants
|
68.7 cm
STANDARD_DEVIATION 5.7 • n=7 Participants
|
65.4 cm
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Thigh Circumference
Middle Thigh
|
55 cm
STANDARD_DEVIATION 4.2 • n=5 Participants
|
60.3 cm
STANDARD_DEVIATION 5.3 • n=7 Participants
|
58.1 cm
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Thigh Circumference
Lower Thigh
|
42.3 cm
STANDARD_DEVIATION 4.4 • n=5 Participants
|
45.8 cm
STANDARD_DEVIATION 3.1 • n=7 Participants
|
44.3 cm
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Percentile of Mean Thigh Circumference
Upper thigh circumference percentile
|
65 Percentile
n=5 Participants
|
95 Percentile
n=7 Participants
|
90 Percentile
n=5 Participants
|
|
Percentile of Mean Thigh Circumference
Lower thigh circumference percentile
|
75 Percentile
n=5 Participants
|
95 Percentile
n=7 Participants
|
90 Percentile
n=5 Participants
|
|
Systolic Blood Pressure (SBP)
|
130 mmHg
STANDARD_DEVIATION 8.8 • n=5 Participants
|
136 mmHg
STANDARD_DEVIATION 10.4 • n=7 Participants
|
133 mmHg
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Limb Occlusion Pressure
|
280 mmHg
STANDARD_DEVIATION 30 • n=5 Participants
|
319 mmHg
STANDARD_DEVIATION 44 • n=7 Participants
|
302 mmHg
STANDARD_DEVIATION 43 • n=5 Participants
|
|
Ankle Brachial Index (ABI)
|
1.15 Ratio
STANDARD_DEVIATION 0.08 • n=5 Participants
|
1.16 Ratio
STANDARD_DEVIATION 0.11 • n=7 Participants
|
1.16 Ratio
STANDARD_DEVIATION 0.09 • n=5 Participants
|
PRIMARY outcome
Timeframe: For 1 sustained minute after application of each tourniquet intervention.Population: One ultrasound image from one of the participants of the pneumatic tourniquet (ATS) group failed to capture anatomy and was therefore not included in the analysis. One ultrasound image from one of the participants of the windlass tourniquet (SOFTT-W) group failed to capture anatomy and was therefore not included in the analysis.
Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of a each tourniquet intervention to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered successful occlusion. A still image is then saved for later evaluation by the blinded outcome assessor. The 5 cm tape was discontinued after the 4th participant because the tape was considered to unacceptably narrow after stretching and this was considered a mechanical failure even if occlusion was observed. Therefore the 5 cm tape data was not evaluated by the radiologist.
Outcome measures
| Measure |
Tourniquet Tape 10 cm
n=19 Participants
Tourniquet Tape 10 cm (4 inch) width. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful. A still image is then saved for later evaluation by the blinded outcome assessor.
|
Pneumatic Tourniquet
n=18 Participants
Automatic pneumatic tourniquet with a 10 cm (4 inch) wide cuff applied to the upper half of the participants thigh. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful. A still image is then saved for later evaluation by the blinded outcome assessor.
|
One Windlass Tourniquet
n=18 Participants
Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of a one windlass tourniquet to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered successful occlusion. A still image is then saved for later evaluation by the blinded outcome assessor.
|
Two Windlass Tourniquets
n=10 Participants
Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of two windlass tourniquets to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered successful occlusion. A still image is then saved for later evaluation by the blinded outcome assessor.
|
Tourniquet Tape 5 cm
Tourniquet Tape 5 cm (2 inch) width. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful.
|
|---|---|---|---|---|---|
|
Radiologist Limb Occlusion Assessment
Success: Absent flow verified by radiologist.
|
19 Participants
|
18 Participants
|
8 Participants
|
8 Participants
|
—
|
|
Radiologist Limb Occlusion Assessment
Failure: Flow verified by radiologist.
|
0 Participants
|
0 Participants
|
10 Participants
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: For 1 sustained minute after application of each tourniquet intervention.Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of each tourniquet intervention to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered a successful occlusion. This assessment was made by the investigator and ultrasonographer applying the intervention.
Outcome measures
| Measure |
Tourniquet Tape 10 cm
n=19 Participants
Tourniquet Tape 10 cm (4 inch) width. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful. A still image is then saved for later evaluation by the blinded outcome assessor.
|
Pneumatic Tourniquet
n=19 Participants
Automatic pneumatic tourniquet with a 10 cm (4 inch) wide cuff applied to the upper half of the participants thigh. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful. A still image is then saved for later evaluation by the blinded outcome assessor.
|
One Windlass Tourniquet
n=19 Participants
Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of a one windlass tourniquet to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered successful occlusion. A still image is then saved for later evaluation by the blinded outcome assessor.
|
Two Windlass Tourniquets
n=11 Participants
Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of two windlass tourniquets to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered successful occlusion. A still image is then saved for later evaluation by the blinded outcome assessor.
|
Tourniquet Tape 5 cm
n=4 Participants
Tourniquet Tape 5 cm (2 inch) width. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful.
|
|---|---|---|---|---|---|
|
Investigator Limb Occlusion Assessment
Success: Absent flow observed by investigator.
|
19 Participants
|
19 Participants
|
8 Participants
|
9 Participants
|
3 Participants
|
|
Investigator Limb Occlusion Assessment
Failure: Flow observed by investigator.
|
0 Participants
|
0 Participants
|
11 Participants
|
2 Participants
|
1 Participants
|
Adverse Events
Pneumatic Tourniquet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Windlass Tourniquet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tourniquet Tape 5 cm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tourniquet Tape 10 cm
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