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Completed

NCT Number: NCT03584100

Effect of Pneumatic Tourniquet on Arm Swelling After Lymph Node Removal

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.

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Key information

Conditions

Healthy Subject

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Tourniquet 8000

Device

Pneumatic tourniquet with appropriate upper extremity cuff, pressure sensing, and ability to set device at 40 mmHg of pressure

Other names: Pneumatic tourniquet

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 12, 2018
Registry last updated
Dec 13, 2023

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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