Trial Outcomes & Findings for Clinical Trial to Assess the Effectiveness of Applying Dry Local Heat and/ or High Tourniquet Pressure for Venipuncture. (NCT NCT04027218)
NCT ID: NCT04027218
Last Updated: 2019-11-13
Results Overview
Number of participants with successful venous catheterization at the first attempt (effectiveness)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
From 1-5 minutes
Results posted on
2019-11-13
Participant Flow
63 individuals signed informed consent form, but one of them did not meet all the inclusion criteria. Then 62 participants were included in the study.
Participant milestones
| Measure |
Current Clinical Practice First, Washout, Then Dry Heat
First (day 1): The standardized and approved Clinical and Laboratory Standards Institute (CLSI) GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
Washout (1 week)
Second (1 day): Dry heat: The application is made with two sacks of carob seeds during 7 minutes. The sacks are placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power.
|
Current Clinical Practice First, Washout, Then High Pressure
First (day 1):The standardized and approved CLSI GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
Washout (1 week)
Second (1 day): High pressure: It will be carried out with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand (QUIRUMED) with European Conformity (CE) marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse.
|
Current Clinical Practice First, Washout, Then Combination
First (day 1): The standardized and approved CLSI GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
Washout (1 week)
Second (1 day): Combination of dry heat and high pressure: as described in dry heat application, and after 7 minutes, high pressure was applied as described for high pressure intervention.
|
Dry Heat First, Washout, Then Current Clinical Practice
First ( day 1): Dry heat: The application is made with two sacks of carob seeds during 7 minutes. The sacks are placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power.
Washout (1 week)
Second (day 1): The standardized and approved Clinical and Laboratory Standards Institute (CLSI) GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
|
High Pressure First, Washout, Then Current Clinical Practice
First (day 1): High pressure: It will be carried out with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand (QUIRUMED) with European Conformity (CE) marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse.
Washout (1 week)
Second (8 day 1):The standardized and approved CLSI GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
|
Combination First, Washout, Then Current Clinical Practice
First (day 1): Combination of dry heat and high pressure: as described in dry heat application, and after 7 minutes, high pressure was applied as described for high pressure intervention.
Washout (1 week)
Second (day 1): The standardized and approved CLSI GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
9
|
11
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
8
|
9
|
11
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Trial to Assess the Effectiveness of Applying Dry Local Heat and/ or High Tourniquet Pressure for Venipuncture.
Baseline characteristics by cohort
| Measure |
Current Clinical Practice First, Washout, Then Dry Heat
n=10 Participants
First (day 1):The standardized and approved Clinical and Laboratory Standards Institute (CLSI) GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
Washout (1 week)
Second (1 day). Dry heat: The application is made with two sacks of carob seeds during 7 minutes. The sacks are placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power.
|
Current Clinical Practice First, Washout, Then High Pressure
n=8 Participants
First (1 day): The standardized and approved CLSI GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
Washout (1 week) .
Second (1 day): High pressure: It will be carried out with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand (QUIRUMED) with European Conformity (CE) marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse.
|
Current Clinical Practice First, Washout, Then Combination
n=9 Participants
First (day 1):The standardized and approved CLSI GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
Washout (1 week)
Second (1 day): Combination of dry heat and high pressure: as described in dry heat application, and after 7 minutes, high pressure was applied as described for high pressure intervention.
|
Dry Heat First, Washout, Then Current Clinical Practice
n=11 Participants
First (1 day). Dry heat: The application is made with two sacks of carob seeds during 7 minutes. The sacks are placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power.
Washout (1 week)
Second (day 1):The standardized and approved Clinical and Laboratory Standards Institute (CLSI) GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
|
High Pressure First, Washout, Then Current Clinical Practice
n=10 Participants
First (1 day): High pressure: It will be carried out with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand (QUIRUMED) with European Conformity (CE) marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse.
Washout (1 week)
First (1 day): The standardized and approved CLSI GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
|
Combination First, Washout, Then Current Clinical Practice
n=11 Participants
First (1 day): Combination of dry heat and high pressure: as described in dry heat application, and after 7 minutes, high pressure was applied as described for high pressure intervention.
Washout (1 week)
Second (day 1):The standardized and approved CLSI GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
25.33 years
STANDARD_DEVIATION 3.72 • n=5 Participants
|
30.00 years
STANDARD_DEVIATION 8.22 • n=7 Participants
|
26.78 years
STANDARD_DEVIATION 7.80 • n=5 Participants
|
27.36 years
STANDARD_DEVIATION 3.80 • n=4 Participants
|
26.30 years
STANDARD_DEVIATION 4.71 • n=21 Participants
|
25.45 years
STANDARD_DEVIATION 6.91 • n=8 Participants
|
26.72 years
STANDARD_DEVIATION 5.881 • n=8 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
39 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
37 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Grade of Venous International Assessment (VIA) scale
Grade II
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
|
Grade of Venous International Assessment (VIA) scale
Grade III
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
|
Grade of Venous International Assessment (VIA) scale
Grade IV
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
|
Grade of Venous International Assessment (VIA) scale
Grade V
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From 1-5 minutesNumber of participants with successful venous catheterization at the first attempt (effectiveness)
Outcome measures
| Measure |
Dry Heat
n=21 Participants
Dry heat: The application is made with two sacks of carob seeds during 7 minutes. The sacks are placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power.
|
High Pressure
n=18 Participants
High pressure: It will be carried out with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand (QUIRUMED) with European Conformity (CE) marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse.
|
Combination
n=20 Participants
Combination of dry heat and high pressure: The application is made with two sacks of carob seeds during 7 minutes, then application of high pressure as described is carried out.
|
Current Clinical Practice
n=59 Participants
The standardized and approved Clinical and Laboratory Standards Institute (CLSI) GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
|
|---|---|---|---|---|
|
Number of Participants With Successful Venous Catheterization at the First Attempt
|
21 Participants
|
18 Participants
|
19 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: up to ten minutes after application of interventionVein perception in VIA scale was considered as the self-reported visual observation or palpation of a venous pathway. Subjects were graded using the current clinical practice vein stagnation with an elastic compressor application (Unidix®). Five grades considering the numbers of points of optimal puncture visible and tangible, in one of the dorsal veins of the hand, forearm cephalic and/or basilic. Grade I: At least six. Grade II: At least four. Grade III: At least three. Grade IV: At least one. Grade V: None. Therefore, the best grade is I, and the worst grade is V. Higher scores mean a worse outcome.
Outcome measures
| Measure |
Dry Heat
n=21 Participants
Dry heat: The application is made with two sacks of carob seeds during 7 minutes. The sacks are placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power.
|
High Pressure
n=18 Participants
High pressure: It will be carried out with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand (QUIRUMED) with European Conformity (CE) marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse.
|
Combination
n=20 Participants
Combination of dry heat and high pressure: The application is made with two sacks of carob seeds during 7 minutes, then application of high pressure as described is carried out.
|
Current Clinical Practice
n=59 Participants
The standardized and approved Clinical and Laboratory Standards Institute (CLSI) GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
|
|---|---|---|---|---|
|
Number of the Grade of Venous International Assessment (VIA) Scale After Application of Intervention
|
2 units on a scale
Interval 1.0 to 4.0
|
2 units on a scale
Interval 1.0 to 4.0
|
1 units on a scale
Interval 1.0 to 3.0
|
3 units on a scale
Interval 2.0 to 5.0
|
SECONDARY outcome
Timeframe: up to 2 hours after application of interventionVisual Analogue Scale (VAS) in pain was measured by integer number. Pain was self-expressed by participants, in a range from 0 to 10. 10: was considered the worst pain experienced 0: no pain perceived. The entire range was 0, 1, 2, 3, 4, 5 , 6, 7, 8, 9, 10. Therefore, higher scores mean a worse outcome.
Outcome measures
| Measure |
Dry Heat
n=21 Participants
Dry heat: The application is made with two sacks of carob seeds during 7 minutes. The sacks are placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power.
|
High Pressure
n=18 Participants
High pressure: It will be carried out with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand (QUIRUMED) with European Conformity (CE) marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse.
|
Combination
n=20 Participants
Combination of dry heat and high pressure: The application is made with two sacks of carob seeds during 7 minutes, then application of high pressure as described is carried out.
|
Current Clinical Practice
n=59 Participants
The standardized and approved Clinical and Laboratory Standards Institute (CLSI) GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
|
|---|---|---|---|---|
|
Number of the Grade in Visual Analogue Scale (VAS) for Pain After Intervention
|
3 units on a scale
Interval 0.0 to 7.0
|
2 units on a scale
Interval 0.0 to 6.0
|
2.5 units on a scale
Interval 0.0 to 8.0
|
3 units on a scale
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: up to 2 hours after application of interventionNumber of participants in each type of skin standardized according to Fitzpatrick scale. Fitzpatrick scale is the UNABBREVIATED scale that indicates different types of skin described as "phototypes". The individuals were graded clinically by sel-expressed by participants in the area of the forearm not exposed to the sun. In a range of six phototypes, where phototype I corresponds with the minimum and phototype VI the maximum. Phototype I: Ivory white, burns easily, never tans. Phototype II: White, burns easily, tans minimally with difficulty. Phototype III: White, burns moderately, tans moderately and uniformly Phototype IV: Beige-olive, lightly tanned, burns minimally, tans moderately and easily. Phototype V: Rarely burns, tans profusely. Phototype VI: Dark brown or black, never burns, tans profusely. Phototype I was considered more risky outcome for expected adverse events in skin. None was considered better or worse outcome.
Outcome measures
| Measure |
Dry Heat
n=21 Participants
Dry heat: The application is made with two sacks of carob seeds during 7 minutes. The sacks are placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power.
|
High Pressure
n=18 Participants
High pressure: It will be carried out with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand (QUIRUMED) with European Conformity (CE) marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse.
|
Combination
n=20 Participants
Combination of dry heat and high pressure: The application is made with two sacks of carob seeds during 7 minutes, then application of high pressure as described is carried out.
|
Current Clinical Practice
n=59 Participants
The standardized and approved Clinical and Laboratory Standards Institute (CLSI) GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
|
|---|---|---|---|---|
|
Number of Participants in Each Type of Skin Standardized According to Fitzpatrick Scale
Phototype I
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants in Each Type of Skin Standardized According to Fitzpatrick Scale
Phototype II
|
2 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants in Each Type of Skin Standardized According to Fitzpatrick Scale
Phototype III
|
9 Participants
|
6 Participants
|
8 Participants
|
23 Participants
|
|
Number of Participants in Each Type of Skin Standardized According to Fitzpatrick Scale
Phototype IV
|
7 Participants
|
8 Participants
|
8 Participants
|
23 Participants
|
|
Number of Participants in Each Type of Skin Standardized According to Fitzpatrick Scale
Phototype V
|
1 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants in Each Type of Skin Standardized According to Fitzpatrick Scale
Phototype VI
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 9 days after first intervention completionDetection level of absorbance values of hemolysis in plasma samples. The units of absorbance are dimensionless. The hemolysis in plasma is analyzed by spectrophotometry method, using a NanoDrop® 2000 Spectrophotometer device (Thermo Fisher Scientific Inc., Wilmington, United States of America). The following equation was used to correct lipemia: (A414-A385) +0.16xA385. Additionally, a baseline correction factor at 750 nanometer wavelength was applied. Therefore, absorbance were measured at 414 nanometer, 385 nanometer and 750 nanometer. Higher values represent a worse outcome: higher value mean higher hemolysis in a blood sample. Therefore, lower values, near to zero are better outcomes that mean low hemolysis in blood sample.
Outcome measures
| Measure |
Dry Heat
n=21 Participants
Dry heat: The application is made with two sacks of carob seeds during 7 minutes. The sacks are placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power.
|
High Pressure
n=18 Participants
High pressure: It will be carried out with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand (QUIRUMED) with European Conformity (CE) marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse.
|
Combination
n=20 Participants
Combination of dry heat and high pressure: The application is made with two sacks of carob seeds during 7 minutes, then application of high pressure as described is carried out.
|
Current Clinical Practice
n=59 Participants
The standardized and approved Clinical and Laboratory Standards Institute (CLSI) GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
|
|---|---|---|---|---|
|
Level of Hemolysis in Absorbance Units
|
0.08 Absorbance units
Interval 0.02 to 0.25
|
0.08 Absorbance units
Interval 0.06 to 0.6
|
0.14 Absorbance units
Interval 0.05 to 0.45
|
0.07 Absorbance units
Interval 0.0 to 1.17
|
SECONDARY outcome
Timeframe: During the study completion,. an average of 30 days.Number of adverse events by visual inspection.
Outcome measures
| Measure |
Dry Heat
n=21 Participants
Dry heat: The application is made with two sacks of carob seeds during 7 minutes. The sacks are placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power.
|
High Pressure
n=18 Participants
High pressure: It will be carried out with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand (QUIRUMED) with European Conformity (CE) marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse.
|
Combination
n=20 Participants
Combination of dry heat and high pressure: The application is made with two sacks of carob seeds during 7 minutes, then application of high pressure as described is carried out.
|
Current Clinical Practice
n=59 Participants
The standardized and approved Clinical and Laboratory Standards Institute (CLSI) GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
7 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
Adverse Events
Dry Heat
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
High Pressure
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Combination
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Current Clinical Practice
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dry Heat
n=21 participants at risk
Dry heat: The application is made with two sacks of carob seeds during 7 minutes. The sacks are placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power.
|
High Pressure
n=21 participants at risk；n=18 participants at risk
High pressure: It will be carried out with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand (QUIRUMED) with European Conformity (CE) marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse.
|
Combination
n=20 participants at risk
Combination of dry heat and high pressure: The application is made with two sacks of carob seeds during 7 minutes, then application of high pressure as described is carried out.
|
Current Clinical Practice
n=59 participants at risk
The standardized and approved Clinical and Laboratory Standards Institute (CLSI) GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Local erythema
|
33.3%
7/21 • Number of events 7 • Adverse events were collected during the study completion, an average of 30 days.
Because in this clinical trial using dry heat and high pressure were only expected local erythema and transient paresthesia as adverse events. The treatment for those adverse events, if applicable, were not consider a requirement of medical or surgical intervention. A supervision (for local erythema) and release the pressure (for transient paresthesia) were considered sufficient as treatment.
|
0.00%
0/21 • Adverse events were collected during the study completion, an average of 30 days.
Because in this clinical trial using dry heat and high pressure were only expected local erythema and transient paresthesia as adverse events. The treatment for those adverse events, if applicable, were not consider a requirement of medical or surgical intervention. A supervision (for local erythema) and release the pressure (for transient paresthesia) were considered sufficient as treatment.
|
30.0%
6/20 • Number of events 6 • Adverse events were collected during the study completion, an average of 30 days.
Because in this clinical trial using dry heat and high pressure were only expected local erythema and transient paresthesia as adverse events. The treatment for those adverse events, if applicable, were not consider a requirement of medical or surgical intervention. A supervision (for local erythema) and release the pressure (for transient paresthesia) were considered sufficient as treatment.
|
0.00%
0/59 • Adverse events were collected during the study completion, an average of 30 days.
Because in this clinical trial using dry heat and high pressure were only expected local erythema and transient paresthesia as adverse events. The treatment for those adverse events, if applicable, were not consider a requirement of medical or surgical intervention. A supervision (for local erythema) and release the pressure (for transient paresthesia) were considered sufficient as treatment.
|
|
Nervous system disorders
Transient paresthesia
|
0.00%
0/21 • Adverse events were collected during the study completion, an average of 30 days.
Because in this clinical trial using dry heat and high pressure were only expected local erythema and transient paresthesia as adverse events. The treatment for those adverse events, if applicable, were not consider a requirement of medical or surgical intervention. A supervision (for local erythema) and release the pressure (for transient paresthesia) were considered sufficient as treatment.
|
4.8%
1/21 • Number of events 1 • Adverse events were collected during the study completion, an average of 30 days.
Because in this clinical trial using dry heat and high pressure were only expected local erythema and transient paresthesia as adverse events. The treatment for those adverse events, if applicable, were not consider a requirement of medical or surgical intervention. A supervision (for local erythema) and release the pressure (for transient paresthesia) were considered sufficient as treatment.
|
0.00%
0/20 • Adverse events were collected during the study completion, an average of 30 days.
Because in this clinical trial using dry heat and high pressure were only expected local erythema and transient paresthesia as adverse events. The treatment for those adverse events, if applicable, were not consider a requirement of medical or surgical intervention. A supervision (for local erythema) and release the pressure (for transient paresthesia) were considered sufficient as treatment.
|
0.00%
0/59 • Adverse events were collected during the study completion, an average of 30 days.
Because in this clinical trial using dry heat and high pressure were only expected local erythema and transient paresthesia as adverse events. The treatment for those adverse events, if applicable, were not consider a requirement of medical or surgical intervention. A supervision (for local erythema) and release the pressure (for transient paresthesia) were considered sufficient as treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place