Clinical Trial to Assess the Effectiveness of Applying Dry Local Heat and/ or High Tourniquet Pressure for Venipuncture. (ECYPVEN-H/17)
Venipuncture, Healthy Adult
About this trial
This is an interventional supportive care trial for Venipuncture focused on measuring venipuncture, hemolysis, heat, pressure, safety
Eligibility Criteria
Inclusion Criteria:
- Signed the informed consent form for bioequivalence study
- Signed the informed consent form for this clinical trial
- Fluid intake of participants was limited to a volume equal to or less than 500 ml
- Participants fasted 6-8 hours before venous cannulation
- Body mass index (BMI) between 18.5-29.9
- Vein perception by Venous International Assessment (VIA) scale between 5 to 2 grade.
Exclusion Criteria:
- Grade one in VIA scale
- Smokers
- BMI lower than 18.5 or equivalent or higher than 30
- Subjects who had any disease,
- Blood test, urinalysis, physical examination or electrocardiogram showing disorders with clinical relevance
- Subjects receiving treatment for anything apart from contraceptives.
- Gluten, lactose intolerance, vegetarian or vegan subjects for bioequivalence subjects.
Sites / Locations
- Leticia Carmen Simón López
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Current clinical practice-Dry heat
Current clinical practice- Hihg pressure
Current clinical practice-Combination
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. 1 period (current clinical practice) and 2 period (dry heat) or 1 period (dry heat) and 2 period (current clinical practice).
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. 1 period (current clinical practice) and 2 period (high pressure) or 1 period (high pressure) and 2 period (current clinical practice).
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. 1 period (current clinical practice) and 2 period (combination of dry heat and high pressure) or 1 period (combination of dry heat and high pressure) and 2 period (current clinical practice).