Completed

NCT Number: NCT03187041

Sensation and Skin Pressures Under Blood-Draw Tourniquets

Purpose: This research study seeks to determine whether surface pressures generated by elastic tourniquets used by phlebotomists during blood-draws can penetrate to deeper tissues where major arteries and nerves lie. Additionally, investigators will also determine the effects of prolonged tourniquet application on hand sensation using a controlled, reproducible force stimulus. In conjunction, the investigators will also track changes in skin surface pressures and pain levels over this prolonged tourniquet application. Hypothesis: The investigators hypothesize the use of common elastic tourniquets used for blood draws does not significantly impact sensation and will not elicit nerve or tissue damage. Technologies used: Monofilaments and Pressure Sensor

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Key information

Conditions

Skin Pressures Under Blood Draw-tourniquets

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC San Diego Medical Center

San Diego, California, 92103, United States

About this study

The objective of this study is to investigate the reproducibility and consequently the safety of common elastic tourniquet methods for blood draws. Specifically, the study will investigate whether the surface pressures produced by blood draw tourniquets when applied by experienced phlebotomists are significant enough to penetrate to deeper tissue near bone where major arteries and nerves lie. By relating factors including tourniquet width and patient arm circumference to our surface pressure measurements and comparing our results to previous literature, the investigators hope to determine the safety of current blood draw tourniquet procedures.

In addition, the investigators will track changes in skin surface pressures over time to determine if prolonged exposure to these tourniquet pressures has the potential to permanently affect nerve function and muscle in tissues near bone.

Hand sensation will be investigated during a prolonged tourniquet application trial of the study to test the effects of the generated pressures on median, ulnar, and radial nerve viability over time.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 years or older

Exclusion criteria

no history of abnormal heart conditions
no history of coagulation disorders
will not be on prescription medications that affect cardiovascular system (ex: medications that affect blood pressure or cardiac contractility etc.)**
does not have diabetes

Types of medications that affect the cardiovascular system and are part of the exclusion criteria include but are not limited to: anticoagulants, antiaginals, antiarrhythmic agents, anti-hypertensive/hypotensive agents, cardenolides, cardiac stimulants, hypolipidemic agents, inotropic agents, vasoconstrictors, as well as vasodilators.

Treatment and study plan

Sensation and Skin Surface Pressures Under Blood-Draw Tourniquets

Other

Phase 1: Skin surface pressures will be recorded by an investigator during each of the 10 applications of the tourniquet. All 10 tourniquet skin pressure measurements will take place in the Blood Draw clinic at the UCSD Medical Center in Hillcrest on the same day for a subject.

Phase 2: The same 20 subjects will be subjected to a prolonged blood-draw tourniquet application for a duration of 70 minutes. The purpose of phase 2 is to determine whether there is an effect on sensation from prolonged blood tourniquet use. External skin pressures will not exceed 60mmHg. During this prolonged tourniquet application the investigators will monitor changes in hand sensation at 10-minute intervals using Semmes-Weinstein monofilaments on three peripheral nerves of the hand (median, radian, and ulnar).

Primary outcomes

Skin Surface Pressure Under Blood-Draw Tourniquet with Phlebotomists (Phase 1)

Time frame: Phase 1: 10-15 seconds (10 times within a 5 -10 minute period)

The pressure under blood draw tourniquets will be taken in Phases 1 and 2. During phase 1, the tourniquet will remain on the subject for a brief period of time (10-15 seconds) 10 times, allowing for enough time to acquire pressure measurements using the PicoPress device. The difference between Phase 1 and Phase 2 is that phase 1 will be performed with a phlebotomist, while phase 2 will be performed with one of the investigators for an extended period of time.
Skin Surface Pressure Under Blood-Draw Tourniquet and Change in sensation during a 1 hour period (Phase 2)

Time frame: Phase 2: 70 minutes (sensation will be measured every 10 minutes)

Phase 2: The PicoPress will constantly monitor pressure under the arm tourniquet for one hour. The investigators will also simultaneously monitor the changes from baseline in sensation using Semmes-Weinstein Monofilaments on the radial, ulnar, and median nerves in participants.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Skin Surface Pressures Under Blood-Draw Tourniquets

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Jun 14, 2017
Registry last updated: Feb 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.