Neurologic Examination of Wide and Narrow Tourniquets

NCT ID: NCT02023476

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2010-09-30

Brief Summary

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.

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).

Conditions

Nerve Compression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

wide tourniquet

(Zimmer A.T.S.®3000 ) wide tourniquet MRI intervention

Group Type: EXPERIMENTAL

MRI

Intervention Type: RADIATION

MRI- imaging on the upper arm

narrow tourniquet

HemaClear ™ tourniquet MRI intervention

Group Type: ACTIVE_COMPARATOR

MRI

Intervention Type: RADIATION

MRI- imaging on the upper arm

Interventions

MRI

MRI- imaging on the upper arm

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Dr. Florian M Kovar

Univ. Lektor Dr. med. univ

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Florian M Kovar, MD

Role: PRINCIPAL_INVESTIGATOR

MUW

Locations

RIAO, Sinai Hospital Baltimore

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HEM

Identifier Type: -

Identifier Source: org_study_id