Effect of Pneumatic Tourniquet on Arm Swelling After Lymph Node Removal

NCT03584100 | Completed Results DMC FDA Device

• 3 other identifiers: IRB-40228NCI-2018-01125BRS0075
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subject

Outcome Measures

Primary Outcomes (1)

• Change in Hand Volume Following 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 Outcomes (1)

• Difference in Hand Volume Following Tourniquet Use, Between ALND and Control Limbs

  30 minutes

Study Arms (2)

Patients with prior axillary lymph node dissection

EXPERIMENTAL

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

Healthy Volunteers

ACTIVE COMPARATOR

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

Interventions

Tourniquet 8000 DEVICE

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

Also known as: Pneumatic tourniquet

Healthy Volunteers; Patients with prior axillary lymph node dissection

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Location

Results Point of Contact

• Title: Jeffrey Yao
• Organization: Stanford University

jyao@stanford.edu

650-723-5643

Study Officials

• Jeffrey Yao

  Stanford Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 12, 2018
• Study Start: November 7, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: December 13, 2023
• Results First Posted: June 24, 2021

Record last verified: 2023-11

Locations

US (1)