Neurologic Examination of Wide and Narrow Tourniquets (HEM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02023476
Recruitment Status : Completed
First Posted : December 30, 2013
Last Update Posted : January 10, 2014
Information provided by (Responsible Party):
Dr. Florian M Kovar, Medical University of Vienna

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.

Condition or disease Intervention/treatment Phase
Nerve Compression Radiation: MRI Not Applicable

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  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Nerve Function in Healthy Human Volunteers With Two Different Tourniquets
Study Start Date : April 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

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

Primary Outcome Measures :
  1. Nerve compression [ Time Frame: 20 Minutes ]

Secondary Outcome Measures :
  1. Nerve compression [ Time Frame: 20 minutes ]

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02023476

United States, Maryland
RIAO, Sinai Hospital Baltimore
Baltimore, Maryland, United States, 21215-5271
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Florian M Kovar, MD MUW

Responsible Party: Dr. Florian M Kovar, Univ. Lektor Dr. med. univ, Medical University of Vienna Identifier: NCT02023476     History of Changes
Other Study ID Numbers: HEM
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014