NCT03584100

Effect of Pneumatic Tourniquet on Arm Swelling After Lymph Node Removal

Completed NA Results posted Last updated 13 December 2023

What this trial tests

NA trial testing Tourniquet 8000 in Healthy Subject in 12 participants. Completed in 30 June 2020.

Timeline

7 November 2018

Primary endpoint
30 June 2020

30 June 2020

Quick facts

Lead sponsor	Stanford University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	12
Start date	7 November 2018
Primary completion	30 June 2020
Estimated completion	30 June 2020
Sites	1 location across United States

Drugs / interventions tested

• Tourniquet 8000

Conditions studied

• Healthy Subject — all drugs for Healthy Subject →

Sponsor

Stanford University

Who can join

19 and older, any sex, with Healthy Subject. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Hand Volume Following Tourniquet Use Primary · 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 placem

Mean Difference in Hand Volume, Elevated Position

Group	Value	95% CI
Change in Hand Volume Following Tourniquet Use in Axillary Lymph Node Dissection (ALND) Arm	15.0	± 8.5
Change in Hand Volume Following Tourniquet Use in Contralateral Arm	12.1	± 5.4

Mean Difference in Hand Volume, Sling Position

Group	Value	95% CI
Change in Hand Volume Following Tourniquet Use in Axillary Lymph Node Dissection (ALND) Arm	12.5	± 8.9
Change in Hand Volume Following Tourniquet Use in Contralateral Arm	7.9	± 6.9

Difference in Hand Volume Following Tourniquet Use, Between ALND and Control Limbs Secondary · 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 h

Group	Value	95% CI
Difference in Hand Volume, Axillary Lymph Node Dissection (ALND) vs Contralateral Arms, Elevated	2.9
Difference in Hand Volume, Axillary Lymph Node Dissection (ALND) vs Contralateral Arms, Sling	4.6

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.