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Completed

NCT Number: NCT02023476

Neurologic Examination of Wide and Narrow 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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RIAO, Sinai Hospital Baltimore

Baltimore, Maryland, 21215-5271, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI

Radiation

MRI- imaging on the upper arm

Primary outcomes

  1. Nerve compression

    Time frame: 20 Minutes

    mg/mm2

Secondary outcomes

  1. Nerve compression

    Time frame: 20 minutes

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Nerve Function in Healthy Human Volunteers With Two Different Tourniquets

Acronym: HEM

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 30, 2013
Registry last updated
Jan 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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