Effect of Pneumatic Tourniquet on Arm Swelling After Lymph Node Removal

November 20, 2023 updated by: Jeffrey Yao, MD, Stanford University

The Effect of Pneumatic Tourniquet Use on Upper Extremity Edema Following Axillary Lymph Node Dissection

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

PROCEDURE:

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Pneumatic tourniquet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Hand Volume Following Tourniquet Use
Time Frame: 30 minutes after tourniquet use

Hand volume, as an indicator of limb edema / fluid accumulation, was determined with an aqueous volumeter at rest and for the sling and elevated arm positions 30 minutes after an arm tourniquet was placed. Measurements were taken for the affected arm [ie, after axillary lymph node dissection (ALND)], and the same patient's contralateral arm (control, ie, "other arm").

The mean values for each arm (affected vs control) of the participant group, before (baseline) and 30 minutes after placement of the pneumatic tourniquet were obtained. The difference represents the effect of tourniquet placement. The outcome is reported as the overall mean difference in hand volume from baseline to 30 minutes after tourniquet placement for the ALND arm (affected arm) and the contralateral arm (control arm), with standard deviation.

12 patients only.
30 minutes after tourniquet use

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in Hand Volume Following Tourniquet Use, Between ALND and Control Limbs
Time Frame: 30 minutes
Hand volume, as an indicator of limb edema / fluid accumulation, was determined with an aqueous volumeter 30 minutes after an arm tourniquet was placed and the arm held in sling and elevated arm positions. Measurements were taken for the affected arm [ie, after axillary lymph node dissection (ALND)], and the same patient's contralateral arm (control, ie, "other arm"). Measurements were compared to the participant's contralateral control ("the other arm") in the same positions. The difference represents to effect of ALND on hand volume. The outcome is reported as the absolute change in mean hand volume between the affected and control arms, a number without dispersion.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeffrey Yao, Stanford Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-40228
  • NCI-2018-01125 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • BRS0075 (Other Identifier: OnCore)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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