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N/A N=62 Randomized Single-blind Supportive Care

Clinical Trial to Assess the Effectiveness of Applying Dry Local Heat and/ or High Tourniquet Pressure for Venipuncture.

Venipuncture · Healthy Adult

Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants With Successful Venous Catheterization at the First Attempt — 21; 18; 19; 28 Participants — p=0.001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Dry heat (Device); High pressure (Device); Combination of dry heat and high pressure (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Universidad Complutense de Madrid
Primary completion
Jul 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Successful Venous Catheterization at the First Attempt
21; 18; 19; 28 0.001 sig
SECONDARY
Number of the Grade of Venous International Assessment (VIA) Scale After Application of Intervention
2; 2; 1; 3 0.000 sig
SECONDARY
Number of the Grade in Visual Analogue Scale (VAS) for Pain After Intervention
3; 2; 2.5; 3 0.863
SECONDARY
Number of Participants in Each Type of Skin Standardized According to Fitzpatrick Scale
1; 1; 0; 2; 2; 2
SECONDARY
Level of Hemolysis in Absorbance Units
0.08; 0.08; 0.14; 0.07 0.502
SECONDARY
Number of Participants With Adverse Events
7; 1; 6; 0

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. LETICIA CARMEN SIMÓN LÓPEZ Collaborative investigators: Dr. DOLORES OCHOA-MAZARRO (principal investigator of bioequivalence clinical trial), and Sir. SERGIO LUQUERO-BUENO (collaborative researcher) The setting is Clinical trials Unit of Clinical Pharmacology Department. LA PRINCESA HOSPITAL of Madrid. Research Ethical Committee of LA PRINCESA HOSPITAL of Madrid. Any person will monitor this clinical trial because the sponsor and principal researcher are the same person. Nevertheless, an adherence to this protocol will ensure by principal researcher and co-researchers. The three interventions are: 1. To Apply local dry heat. 2. To apply high tourniquet pressure. 3. To apply both of them. (Dry heat and high pressure) The common comparator: Current Clinical practice for peripheral venous catheterization. The main hypothesis: The number of attempts of success venipuncture at first time are influenced by any of the interventions applied before. The main goal: To identify the most effective intervention of applying dry local heat and/or high tourniquet pressure in relation of number success venipuncture attempts, compared to current clinical practice. Design: An experimental, randomized study which is controlled with current clinical practice to insert a peripheral vein catheter. It is an incomplete cross-over clinical trial, with three arms which are involved interventions and a common comparator. Population: Adult healthy subjects. Sample size: It is required to enroll 54 subjects with a 95% of level of confidence and 80% level of power. Main variable: Succeed peripheral vein catheter insertion at first attempt. Effectiveness assessment: The optimal effectiveness is considered when vein cannulation success at first attempt exceeds 95% applying any of the interventions. Planned date to address: It is planned to carry out around June and/or July of 2017 for the main variable.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04027218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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