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

NCT04027218 | Completed Results

• 1 other identifier: 3113
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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. 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. 1.To Apply local dry heat.
2. 2.To apply high tourniquet pressure.
3. 3.To apply both of them. (Dry heat and high pressure) The common comparator: Current Clinical practice for peripheral venous catheterization.

Conditions

Venipuncture; Healthy Adult

Keywords

venipuncture; hemolysis; heat; pressure; safety

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Successful Venous Catheterization at the First Attempt

  Number of participants with successful venous catheterization at the first attempt (effectiveness)

  From 1-5 minutes

Secondary Outcomes (5)

• Number of the Grade of Venous International Assessment (VIA) Scale After Application of Intervention

  up to ten minutes after application of intervention

• Number of the Grade in Visual Analogue Scale (VAS) for Pain After Intervention

  up to 2 hours after application of intervention

• Number of Participants in Each Type of Skin Standardized According to Fitzpatrick Scale

  up to 2 hours after application of intervention

• Level of Hemolysis in Absorbance Units

  up to 9 days after first intervention completion

• Number of Participants With Adverse Events

  During the study completion,. an average of 30 days.

Study Arms (3)

Current clinical practice-Dry heat

ACTIVE COMPARATOR

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).

Device: Dry heat

Current clinical practice- Hihg pressure

ACTIVE COMPARATOR

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).

Device: High pressure

Current clinical practice-Combination

ACTIVE COMPARATOR

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).

Device: Combination of dry heat and high pressure

Interventions

Dry heat DEVICE

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-Dry heat

High pressure DEVICE

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- Hihg pressure

Combination of dry heat and high pressure DEVICE

The application is made with two sacks of carob seeds during 7 minutes. The sacks may be placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power; according to instructions for use. After 7 minutes, the pressure is applied with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand QUIRUMED with CE Marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse.

Current clinical practice-Combination

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: collaborator

Study Sites (1)

Leticia Carmen Simón López

Madrid, 28006, Spain

Location

Related Publications (8)

• de la Torre-Montero JC, Montealegre-Sanz M, Faraldo-Cabana A, Oliva-Pellicer B, Garcia-Real I, Fenwick M, Marcos Caceres E, Rivas-Eguia B, Vila-Borrajo C, Valles-Andres J, Alonso-Gordoa T, Garcia-Carrion C, Diaz-Rubio Garcia E, Beneit-Montesinos JV. Venous International Assessment, VIA scale, validated classification procedure for the peripheral venous system. J Vasc Access. 2014 Jan-Feb;15(1):45-50. doi: 10.5301/jva.5000173. Epub 2013 Sep 4.

  PMID: 24043322 BACKGROUND

• Eilers S, Bach DQ, Gaber R, Blatt H, Guevara Y, Nitsche K, Kundu RV, Robinson JK. Accuracy of self-report in assessing Fitzpatrick skin phototypes I through VI. JAMA Dermatol. 2013 Nov;149(11):1289-94. doi: 10.1001/jamadermatol.2013.6101.

  PMID: 24048361 BACKGROUND

• Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.

  PMID: 21856077 BACKGROUND

• Fink RM, Hjort E, Wenger B, Cook PF, Cunningham M, Orf A, Pare W, Zwink J. The impact of dry versus moist heat on peripheral IV catheter insertion in a hematology-oncology outpatient population. Oncol Nurs Forum. 2009 Jul;36(4):E198-204. doi: 10.1188/09.ONF.E198-E204.

  PMID: 19581223 BACKGROUND

• Yamagami Y, Tomita K, Tsujimoto T, Inoue T. Tourniquet application after local forearm warming to improve venodilation for peripheral intravenous cannulation in young and middle-aged adults: A single-blind prospective randomized controlled trial. Int J Nurs Stud. 2017 Jul;72:1-7. doi: 10.1016/j.ijnurstu.2017.03.009. Epub 2017 Mar 27.

  PMID: 28410510 BACKGROUND

• Lima-Oliveira G, Lippi G, Salvagno GL, Montagnana M, Picheth G, Guidi GC. Impact of the phlebotomy training based on CLSI/NCCLS H03-a6 - procedures for the collection of diagnostic blood specimens by venipuncture. Biochem Med (Zagreb). 2012;22(3):342-51. doi: 10.11613/bm.2012.036.

  PMID: 23092065 BACKGROUND

• Shah JS, Soon PS, Marsh DJ. Comparison of Methodologies to Detect Low Levels of Hemolysis in Serum for Accurate Assessment of Serum microRNAs. PLoS One. 2016 Apr 7;11(4):e0153200. doi: 10.1371/journal.pone.0153200. eCollection 2016.

  PMID: 27054342 BACKGROUND

• Simon-Lopez LC, Ortuno-Soriano I, Luengo-Gonzalez R, Posada-Moreno P, Zaragoza-Garcia I, Sanchez-Gomez R. Proposal and Strategy for Nursing-Led Research: Protocol for an Unfunded Clinical Trial. JMIR Res Protoc. 2025 Feb 10;14:e56062. doi: 10.2196/56062.

  PMID: 39927682 DERIVED

MeSH Terms

Conditions

Hemolysis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ms. Leticia Carmen Simón López
• Organization: University

leticia.simon25@gmail.com

+34 680721340

Study Officials

• Leticia Carmen Simón López, RN

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: For hemolysis analysis in blood samples, the responsible of analysis by spectrophotometry is blinded from the intervention or comparator used for blood sample performed, using two different departments: one for interventions and comparator applications and other for spectrophotometer.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental, randomized and controlled study with the usual technique of inserting a venipuncture catheter until now. Incomplete clinical trial, blind to third parties, in healthy volunteers, which consists of three arms, in which they are intervened and the comparator is applied.

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 19, 2019
• Study Start: July 9, 2017
• Primary Completion: July 23, 2017
• Study Completion: April 3, 2018
• Last Updated: November 13, 2019
• Results First Posted: October 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: A Clinical STudy Report is already available for Ethics Committee of La PRINCESA Hospital. Moreover, an original article of the results of the study is being prepared.
• Access Criteria: Available as majority as possible.

Locations

ES (1)