Healthy Subject
Conditions
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.
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.
Interventions
DEVICETourniquet 8000
Pneumatic tourniquet with appropriate upper extremity cuff, pressure sensing, and ability to set device at 40 mmHg of pressure
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hand Volume Following Tourniquet Use | 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
| Measure | Time frame | Description |
|---|---|---|
| Difference in Hand Volume Following Tourniquet Use, Between ALND and Control Limbs | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tourniquet 8000 Arm Both arms of participants (Auxillary lymph node dissection (ALND) and other contralateral) were used. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Tourniquet 8000 Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 66.1 years STANDARD_DEVIATION 11.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
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.
Time frame: 30 minutes after tourniquet use
Population: Both arms of all participants were measured and are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Change in Hand Volume Following Tourniquet Use in Axillary Lymph Node Dissection (ALND) Arm | Change in Hand Volume Following Tourniquet Use | Mean Difference in Hand Volume, Elevated Position | 15.0 mL | Standard Deviation 8.5 |
| Change in Hand Volume Following Tourniquet Use in Axillary Lymph Node Dissection (ALND) Arm | Change in Hand Volume Following Tourniquet Use | Mean Difference in Hand Volume, Sling Position | 12.5 mL | Standard Deviation 8.9 |
| Change in Hand Volume Following Tourniquet Use in Contralateral Arm | Change in Hand Volume Following Tourniquet Use | Mean Difference in Hand Volume, Elevated Position | 12.1 mL | Standard Deviation 5.4 |
| Change in Hand Volume Following Tourniquet Use in Contralateral Arm | Change in Hand Volume Following Tourniquet Use | Mean Difference in Hand Volume, Sling Position | 7.9 mL | Standard Deviation 6.9 |
Secondary
Difference in Hand Volume Following Tourniquet Use, Between ALND and Control Limbs
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Change in Hand Volume Following Tourniquet Use in Axillary Lymph Node Dissection (ALND) Arm | Difference in Hand Volume Following Tourniquet Use, Between ALND and Control Limbs | 2.9 mL |
| Change in Hand Volume Following Tourniquet Use in Contralateral Arm | Difference in Hand Volume Following Tourniquet Use, Between ALND and Control Limbs | 4.6 mL |