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Effect of Pneumatic Tourniquet on Arm Swelling After Lymph Node Removal

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ClinicalTrials.gov Identifier: NCT03584100
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief Summary:
The purpose of the proposed study is to evaluate the acute impact of swelling caused by low-pressure tourniquet use in the setting of ipsilateral prior axillary lymph node dissection and the change in swelling reduction following tourniquet use in three limb postures versus healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Subject Device: Tourniquet 8000 Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate reduction in swelling and safety of tourniquet use in patients with prior axillary lymph node dissection

OUTLINE:

Participants raise their arm for 15 minutes, then wear a tourniquet inflated for 25 minutes. Hand volume is measured by aqueous volumeter at baseline, after use of the tourniquet and every 5 minutes for 30 minutes, while the arm is placed at a raised on head position, shoulder-level brace position, or at waist in a sling position.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Pneumatic Tourniquet Use on Upper Extremity Edema Following Axillary Lymph Node Dissection
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Patients with prior axillary lymph node dissection
Participants raise their arm for 15 minutes, then wear a tourniquet 8000 inflated for 25 minutes. Hand volume is measured by aqueous volumeter at baseline, after use of the tourniquet and every 5 minutes for 30 minutes, while the arm is placed at a raised on head position, shoulder-level brace position, or at waist in a sling position.
Device: Tourniquet 8000
Pneumatic tourniquet with appropriate upper extremity cuff, pressure sensing, and ability to set device at 40 mmHg of pressure
Other Name: Pneumatic tourniquet

Active Comparator: Healthy Volunteers
Participants raise their arm for 15 minutes, then wear a tourniquet 8000 inflated for 25 minutes. Hand volume is measured by aqueous volumeter at baseline, after use of the tourniquet and every 5 minutes for 30 minutes, while the arm is placed at a raised on head position, shoulder-level brace position, or at waist in a sling position.
Device: Tourniquet 8000
Pneumatic tourniquet with appropriate upper extremity cuff, pressure sensing, and ability to set device at 40 mmHg of pressure
Other Name: Pneumatic tourniquet




Primary Outcome Measures :
  1. Change in hand volume following tourniquet use [ Time Frame: Baseline up to 30 minutes after tourniquet use ]
    Hand volume will be measured before and after use of the pneumatic tourniquet, using aqueous volumeter. The mean values for healthy volunteers and patients before and after use of the pneumatic tourniquet will be computed.


Secondary Outcome Measures :
  1. Change in limb edema over time at 3 limb positions [ Time Frame: Baseline up to 30 minutes after tourniquet use ]
    Hand volume as an indicator of limb edema will be used to assess fluid accumulation in 3 different limb positions (head, brace and sling). Hand volume will be measured in all patients using aqueous volumeter, every 5 mins for 30 mins (6 measurements). The change in hand volume / limb edema as factor of time will be analyzed by a linear mixed effects model to account for the correlations between measurements on the same subject and time after tourniquet use.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have previously undergone axillary lymph node dissection
  • Or healthy volunteers

Exclusion Criteria:

  • Have new-onset lymphedema of the involved limb.
  • Infection including cellulitis
  • Trauma or planned axillary surgery within 6 months of participation
  • Any prior axillary radiation

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 ClinicalTrials.gov identifier (NCT number): NCT03584100


Contacts
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Contact: Veronica Liew 650-725-6134 vliew@stanford.edu

Locations
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United States, California
Stanford University School of Medicine Recruiting
Palo Alto, California, United States, 94304
Contact: Veronica Liew    650-725-6134    vliew@stanford.edu   
Principal Investigator: Jeffrey Yao         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Jeffrey Yao Stanford Cancer Institute

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT03584100     History of Changes
Other Study ID Numbers: BRS0075
NCI-2018-01125 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IRB-40228 ( Other Identifier: Stanford IRB )
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No