Sensation and Skin Pressures Under Blood-Draw Tourniquets

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Skin Surface Pressures Under Blood-Draw Tourniquets

Conditions
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Skin Pressures Under Blood Draw-tourniquets

Intervention / Treatment
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* Other: Sensation and Skin Surface Pressures Under Blood-Draw Tourniquets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: In order to acquire our data, a Microlab PicoPress device will be employed. It has been shown to provide accurate, linear, and reproducible measures of surface pressure between the skin and device. For tourniquets, the investigators will be using a MedSource perforated tourniquet, which is the type of elastic tourniquet the phlebotomists are accustomed to using in their daily practice. For each experiment throughout both phases of the study, the PicoPress pressure sensor will be folded in half and taped over the lateral aspect of the right arm, approximately 2 inches distal to the deltoid muscle along the brachialis muscle. Arm circumferences will be taken prior to experimentation at this same location. For each trial, the phlebotomists will tie the 2.5cm elastic tourniquet around the arm and pressure sensor while ensuring that the tourniquet is not knotted directly on top of the sensor. The study will be divided into two phases of experimentation conducted sequentially.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin surface pressures under tourniquets and sensation<br>Phase 1: Each phlebotomist will apply the tourniquet 10 separate times to the right arm of each subject. The tourniquet will remain on the arm for approximately ten seconds, to be able to allot enough time to collect an accurate pressure measurement. All 10 tourniquet skin pressure measurements will take place on the same day for a subject. Phase 2: 20 subjects will be subjected to a prolonged blood-draw tourniquet application for a duration of 1 hour. The purpose of phase 2 is to determine whether there is an effect on sensation from prolonged blood tourniquet use. | Other: Sensation and Skin Surface Pressures Under Blood-Draw Tourniquets<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Surface Pressure Under Blood-Draw Tourniquet with Phlebotomists (Phase 1) | 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. | Phase 1: 10-15 seconds (10 times within a 5 -10 minute period) | 
| Skin Surface Pressure Under Blood-Draw Tourniquet and Change in sensation during a 1 hour period (Phase 2) | 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. | Phase 2: 70 minutes (sensation will be measured every 10 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood draw tourniquets, skin surface pressure, blood draw band, elastic tourniquet, phlebotomy, tourniquet pressure