An interventional study of Tourniquet 8000 in Healthy Subject, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by Stanford University · Not applicable, Interventional, and Supportive care
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.
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.
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Exclusion Criteria:
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
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
Pneumatic tourniquet with appropriate upper extremity cuff, pressure sensing, and ability to set device at 40 mmHg of pressure
Also known as: Pneumatic tourniquet
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
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
| Milestone | Tourniquet 8000 Arm |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
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.
| mL | Change in Hand Volume Following Tourniquet Use in Axillary Lymph Node Dissection (ALND) Arm | Change in Hand Volume Following Tourniquet Use in Contralateral Arm |
|---|---|---|
| Mean Difference in Hand Volume, Elevated Position | 15.0 ± 8.5 | 12.1 ± 5.4 |
| Mean Difference in Hand Volume, Sling Position | 12.5 ± 8.9 | 7.9 ± 6.9 |
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.
| mL | Difference in Hand Volume, Axillary Lymph Node Dissection (ALND) vs Contralateral Arms, Elevated | Difference in Hand Volume, Axillary Lymph Node Dissection (ALND) vs Contralateral Arms, Sling |
|---|---|---|
| Difference in Hand Volume Following Tourniquet Use, Between ALND and Control Limbs | 2.9 | 4.6 |
Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tourniquet 8000 Arm | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | Tourniquet 8000 Arm |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 7 |
| Age, Continuous(years) | Tourniquet 8000 Arm |
|---|---|
| Mean | 66.1 ± 11.2 |
| Sex: Female, Male(Participants) | Tourniquet 8000 Arm |
|---|---|
| Female | 12 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Tourniquet 8000 Arm |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 10 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Tourniquet 8000 Arm |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 10 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Tourniquet 8000 Arm |
|---|---|
| United States | 12 |
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