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

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.

Conditions

• Venipuncture
• Healthy Adult

Interventions

DEVICE

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.

DEVICE

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.

DEVICE

Combination of dry heat and high pressure

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.

Sponsors & Collaborators

• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  collaborator OTHER

• Universidad Complutense de Madrid

  lead OTHER

Principal Investigators

• Leticia Carmen Simón López, RN · Universidad Complutense de Madrid

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-07-09

Primary Completion

2017-07-23

Completion

2018-04-03

Countries

• Spain

Study Locations