Neurologic Examination of Wide and Narrow Tourniquets (HEM)

Nerve Function in Healthy Human Volunteers With Two Different Tourniquets

Nerve injury is a serious potential complication associated with the clinical use of exsanguinating tourniquets in surgery. Recently, a novel narrow tourniquet has been proposed, with the claim that it may cause less compression of the nerves. We performed an in vivo comparison of a standard wide tourniquet with the new, narrow tourniquet. Our study specifically looked at neurologic markers in the upper extremity.

Study Overview

• Status: Completed
• Conditions: Nerve Compression
• Intervention / Treatment: Radiation: MRI

Detailed Description

The HemaClear ™ OHK Medical Device HemaClear™, approved by FDA, consists of a silicon ring wrapped in a stockinet sleeve and pull straps (Fig.1). It performs three functions - blood removal (exsanguinations), arterial flow occlusion, and placement of sterile stockinet 30. The ring is placed on the extremity and then straps are pulled proximally. The silicone ring rolls up the limb while the stockinet sleeve unfolds onto the limb. During the rolling up process, the ring exerts pressure and squeezes the blood away from the limb. Application of the device takes less than a minute.

The technique behind this device is fundamentally different from classic pneumatic tourniquets, as pressure is exercised by only a single silicon ring so that the profile is very small.

Zimmer A.T.S.®3000 The A.T.S.®3000 is an automatic broad tourniquet system with a Limb Occlusion Pressure (LOP) feature. It is the latest innovation in tourniquet technology and has FDA approval. It was invented by McEwen 4 and the basic function is described in several clinical trials and publications 28. The main difference to other pneumatic tourniquets is the LOP and the Recommended tissue pressure (RTP) feature. These parameters are suitable to optimize the pressure force on the tourniquet for each individual patient. The LOP is detected before inflating the tourniquet and the RTP is the LOP plus a safety margin to guarantee a blood free field (Operator & Service Manual Zimmer A.T.S.® 3000 Automatic tourniquet system REF 60-3000-101-00).

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21215-5271
      • RIAO, Sinai Hospital Baltimore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• self defined Caucasian
• clinically healthy
• BMI of ≤ 30,
• a systolic arterial blood pressure ≤190 mmHg,
• no rash or dermatologic condition or tattoos which may interfere with the placement site
• no neurovascular impairment.
• all female participants received a pregnancy test at the initial screening visit.
• Study population was restricted to Caucasians to enable an assessment of device caused redness or skin lesions, not possible in a mixed study population.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: wide tourniquet; (Zimmer A.T.S.®3000 ) wide tourniquet MRI intervention	Radiation: MRI; MRI- imaging on the upper arm
Active Comparator: narrow tourniquet; HemaClear ™ tourniquet MRI intervention	Radiation: MRI; MRI- imaging on the upper arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nerve compression	mg/mm2	20 Minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Nerve compression	20 minutes

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Florian M Kovar, MD, MUW

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: December 17, 2013
• First Submitted That Met QC Criteria: December 27, 2013
• First Posted (Estimate): December 30, 2013

Study Record Updates

• Last Update Posted (Estimate): January 10, 2014
• Last Update Submitted That Met QC Criteria: January 9, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: HEM