Status:
COMPLETED
Clinical Trial to Assess the Effectiveness of Applying Dry Local Heat and/ or High Tourniquet Pressure for Venipuncture.
Lead Sponsor:
Universidad Complutense de Madrid
Collaborating Sponsors:
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Conditions:
Venipuncture
Healthy Adult
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
Low level intervention health products clinical trial, fourth phase, non-commercial research. Dissertation of COMPLUTENSE UNIVERSITY of Madrid. Principal Investigator of this clinical trial: Ms. LETI...
Detailed Description
The study is considered a low level intervention clinical trial to evaluate the use and safety of a sanitary product marketed and accredited for a different aim, but according to their rules of using....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2018
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04027218
Start Date
July 9 2017
End Date
April 3 2018
Last Update
November 13 2019
Active Locations (1)
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1
Leticia Carmen Simón López
Madrid, Spain, 28006