NCT03187041

Sensation and Skin Pressures Under Blood-Draw Tourniquets

Skin Surface Pressures Under Blood-Draw Tourniquets

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Skin Pressures Under Blood Draw-tourniquets

Interventions

Type	Name	Description
OTHER	Sensation and Skin Surface Pressures Under Blood-Draw Tourniquets	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).

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2017-06-14
• Last updated: 2020-02-07

Locations

1 site across 1 country: United States