Healthy SubjectNCT03584100
Effect of Pneumatic Tourniquet on Arm Swelling After Lymph Node Removal
A study testing Tourniquet 8000 in people with Healthy Subject, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject
- What is being tested?
- Tourniquet 8000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have previously undergone axillary lymph node dissection
- Or healthy volunteers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Palo Alto, California, 94304
About this study
Official title: The Effect of Pneumatic Tourniquet Use on Upper Extremity Edema Following Axillary Lymph Node Dissection
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Healthy Subject
- Being tested
- Tourniquet 8000
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tourniquet 8000Device
Also called Pneumatic tourniquet
Pneumatic tourniquet with appropriate upper extremity cuff, pressure sensing, and ability to set device at 40 mmHg of pressure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Tourniquet 8000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes after tourniquet use
Secondary outcomes (1)
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start7 Nov 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Yao, MD, Stanford University
- Investigators
- Jeffrey Yao, Principal investigator, Stanford Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584100
- Sponsor's protocol ID
- IRB-40228
- Other IDs
- NCI-2018-01125, BRS0075
- Status last verified
- Nov 2023
- First submitted
- 29 Jun 2018
- Last updated
- 13 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pneumatic Tourniquet Use on Upper Extremity Edema Following Axillary Lymph Node Dissection
- ClinicalTrials.gov ID
- NCT03584100
- Acronym / sponsor ID
- IRB-40228
- Conditions
- Healthy Subject
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Posted 24 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with prior axillary lymph node dissection | Experimental | Device: Tourniquet 8000Participants 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. |
| Healthy Volunteers | Active comparator | Device: Tourniquet 8000Participants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have previously undergone axillary lymph node dissection
- Or healthy volunteers
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tourniquet 8000Also: Pneumatic tourniquetPneumatic tourniquet with appropriate upper extremity cuff, pressure sensing, and ability to set device at 40 mmHg of pressure | Device | Healthy Volunteers, Patients with prior axillary lymph node dissection |
Primary outcome
Change in Hand Volume Following Tourniquet Use
Time frame: 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.
1 secondary outcome
Difference in Hand Volume Following Tourniquet Use, Between ALND and Control Limbs
Time frame: 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Yao principal investigator
Stanford Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tourniquet 8000 in people with Healthy Subject, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hand Volume Following Tourniquet Use (time frame: 30 minutes after tourniquet use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.