Trial record 4 of 151 for:    Pinched Nerve

Neurologic Examination of Wide and Narrow Tourniquets (HEM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Florian M Kovar, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT02023476
First received: December 17, 2013
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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 Intervention
Nerve Compression
Radiation: MRI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Nerve Function in Healthy Human Volunteers With Two Different Tourniquets

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Nerve compression [ Time Frame: 20 Minutes ] [ Designated as safety issue: No ]
    mg/mm2


Secondary Outcome Measures:
  • Nerve compression [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: April 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02023476

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

No publications provided

Responsible Party: Dr. Florian M Kovar, Univ. Lektor Dr. med. univ, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02023476     History of Changes
Other Study ID Numbers: HEM
Study First Received: December 17, 2013
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 28, 2014