Trial Outcomes & Findings for Effect of Pneumatic Tourniquet on Arm Swelling After Lymph Node Removal (NCT NCT03584100)

Last Updated: 2023-12-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

30 minutes after tourniquet use

Results posted on

2023-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	Tourniquet 8000 Arm Both arms of participants, ie, auxillary lymph node dissection (ALND) and contralateral (control arm) were evaluated with a low-pressure tourniquet.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Pneumatic Tourniquet on Arm Swelling After Lymph Node Removal

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tourniquet 8000 Arm n=12 Participants Both arms of participants (Auxillary lymph node dissection (ALND) and other contralateral) were used.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	66.1 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes after tourniquet use

Population: Both arms of all participants were measured and are included in the analysis.

Outcome measures

Outcome measures
Measure	Change in Hand Volume Following Tourniquet Use in Axillary Lymph Node Dissection (ALND) Arm n=12 Participants Mean change in hand volume from baseline to 30 minutes after placement of the pneumatic tourniquet, for axillary lymph node dissection (ALND) arm.	Change in Hand Volume Following Tourniquet Use in Contralateral Arm n=12 Participants Mean change in hand volume from baseline to 30 minutes after placement of the pneumatic tourniquet, for contralateral control arm.
Change in Hand Volume Following Tourniquet Use Mean Difference in Hand Volume, Elevated Position	15.0 mL Standard Deviation 8.5	12.1 mL Standard Deviation 5.4
Change in Hand Volume Following Tourniquet Use Mean Difference in Hand Volume, Sling Position	12.5 mL Standard Deviation 8.9	7.9 mL Standard Deviation 6.9

SECONDARY outcome

Timeframe: 30 minutes

Population: Both arms of all participants were measured and are included in the analysis. The reported value is a difference of means, a number without dispersion.

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.

Outcome measures

Outcome measures
Measure	Change in Hand Volume Following Tourniquet Use in Axillary Lymph Node Dissection (ALND) Arm n=24 hands Mean change in hand volume from baseline to 30 minutes after placement of the pneumatic tourniquet, for axillary lymph node dissection (ALND) arm.	Change in Hand Volume Following Tourniquet Use in Contralateral Arm n=24 hands Mean change in hand volume from baseline to 30 minutes after placement of the pneumatic tourniquet, for contralateral control arm.
Difference in Hand Volume Following Tourniquet Use, Between ALND and Control Limbs	2.9 mL	4.6 mL

Adverse Events

Tourniquet 8000 Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeffrey Yao

Stanford University

Phone: 650-723-5643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place