Skin Pressures Under Blood Draw-tourniquetsNCT03187041
Sensation and Skin Pressures Under Blood-Draw Tourniquets
A study testing Sensation and Skin Surface Pressures Under Blood-Draw Tourniquets in people with Skin Pressures Under Blood Draw-tourniquets, run by University of California, San Diego at 1 site in United States.
Trial summary
Purpose: This research study seeks to determine whether surface pressures generated by elastic tourniquets used by phlebotomists during blood-draws can penetrate to deeper tissues where major arteries and nerves lie. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Pressures Under Blood Draw-tourniquets
- What is being tested?
- Sensation and Skin Surface Pressures Under Blood-Draw Tourniquets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
Who cannot join
- no history of abnormal heart conditions
- no history of coagulation disorders
- will not be on prescription medications that affect cardiovascular system (ex: medications that affect blood pressure or cardiac contractility etc.)**
- does not have diabetes
- Types of medications that affect the cardiovascular system and are part of the exclusion criteria include but are not limited to: anticoagulants, antiaginals, antiarrhythmic agents, anti-hypertensive/hypotensive agents, cardenolides, cardiac stimulants, hypolipidemic agents, inotropic agents, vasoconstrictors, as well as vasodilators.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC San Diego Medical Center
San Diego, California, 92103
About this study
Official title: Skin Surface Pressures Under Blood-Draw Tourniquets
Purpose: This research study seeks to determine whether surface pressures generated by elastic tourniquets used by phlebotomists during blood-draws can penetrate to deeper tissues where major arteries and nerves lie. Additionally, investigators will also determine the effects of prolonged tourniquet application on hand sensation using a controlled, reproducible force stimulus. In conjunction, the investigators will also track changes in skin surface pressures and pain levels over this prolonged tourniquet application. Hypothesis: The investigators hypothesize the use of common elastic tourniquets used for blood draws does not significantly impact sensation and will not elicit nerve or tissue damage. Technologies used: Monofilaments and Pressure Sensor
Read the detailed description
The objective of this study is to investigate the reproducibility and consequently the safety of common elastic tourniquet methods for blood draws. Specifically, the study will investigate whether the surface pressures produced by blood draw tourniquets when applied by experienced phlebotomists are significant enough to penetrate to deeper tissue near bone where major arteries and nerves lie. By relating factors including tourniquet width and patient arm circumference to our surface pressure measurements and comparing our results to previous literature, the investigators hope to determine the safety of current blood draw tourniquet procedures.
In addition, the investigators will track changes in skin surface pressures over time to determine if prolonged exposure to these tourniquet pressures has the potential to permanently affect nerve function and muscle in tissues near bone.
Hand sensation will be investigated during a prolonged tourniquet application trial of the study to test the effects of the generated pressures on median, ulnar, and radial nerve viability over time.
- Being tested
- Sensation and Skin Surface Pressures Under Blood-Draw Tourniquets
- Keywords
- blood draw tourniquets, skin surface pressure, blood draw band, elastic tourniquet, phlebotomy, tourniquet pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensation and Skin Surface Pressures Under Blood-Draw TourniquetsOther
Phase 1: Skin surface pressures will be recorded by an investigator during each of the 10 applications of the tourniquet. All 10 tourniquet skin pressure measurements will take place in the Blood Draw clinic at the UCSD Medical Center in Hillcrest on the same day for a subject.
Phase 2: The same 20 subjects will be subjected to a prolonged blood-draw tourniquet application for a duration of 70 minutes. The purpose of phase 2 is to determine whether there is an effect on sensation from prolonged blood tourniquet use. External skin pressures will not exceed 60mmHg. During this prolonged tourniquet application the investigators will monitor changes in hand sensation at 10-minute intervals using Semmes-Weinstein monofilaments on three peripheral nerves of the hand (median, radian, and ulnar).
| Study group | Role | What they receive |
|---|---|---|
| Skin surface pressures under tourniquets and sensation | Experimental | Phase 1: Each phlebotomist will apply the tourniquet 10 separate times to the right arm of each subject. The tourniquet will remain on the arm for approximately ten seconds, to be able to allot enough time to collect an accurate pressure measurement. All 10 tourniquet skin pressure measurements will take place on the same day for a subject.
Phase 2: 20 subjects will be subjected to a prolonged blood-draw tourniquet application for a duration of 1 hour. The purpose of phase 2 is to determine whether there is an effect on sensation from prolonged blood tourniquet use. Receives: Other: Sensation and Skin Surface Pressures Under Blood-Draw Tourniquets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Surface Pressure Under Blood-Draw Tourniquet with Phlebotomists (Phase 1)
The pressure under blood draw tourniquets will be taken in Phases 1 and 2. During phase 1, the tourniquet will remain on the subject for a brief period of time (10-15 seconds) 10 times, allowing for enough time to acquire pressure measurements using the PicoPress device. The difference between Phase 1 and Phase 2 is that phase 1 will be performed with a phlebotomist, while phase 2 will be performed with one of the investigators for an extended period of time.
Measured: Phase 1: 10-15 seconds (10 times within a 5 -10 minute period)
Skin Surface Pressure Under Blood-Draw Tourniquet and Change in sensation during a 1 hour period (Phase 2)
Phase 2: The PicoPress will constantly monitor pressure under the arm tourniquet for one hour. The investigators will also simultaneously monitor the changes from baseline in sensation using Semmes-Weinstein Monofilaments on the radial, ulnar, and median nerves in participants.
Measured: Phase 2: 70 minutes (sensation will be measured every 10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study startDec 2016
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Skin Pressures Under Blood Draw-tourniquetsStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In order to acquire our data, a Microlab PicoPress device will be employed. It has been shown to provide accurate, linear, and reproducible measures of surface pressure between the skin and device. For tourniquets, the investigators will be using a MedSource perforated tourniquet, which is the type of elastic tourniquet the phlebotomists are accustomed to using in their daily practice. For each experiment throughout both phases of the study, the PicoPress pressure sensor will be folded in half and taped over the lateral aspect of the right arm, approximately 2 inches distal to the deltoid muscle along the brachialis muscle. Arm circumferences will be taken prior to experimentation at this same location. For each trial, the phlebotomists will tie the 2.5cm elastic tourniquet around the arm and pressure sensor while ensuring that the tourniquet is not knotted directly on top of the sensor. The study will be divided into two phases of experimentation conducted sequentially.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan R Hargens, PhD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187041
- Sponsor's protocol ID
- 161885
- Status last verified
- Feb 2020
- First submitted
- 9 Jun 2017
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared.
Publications
Crenshaw AG, Hargens AR, Gershuni DH, Rydevik B. Wide tourniquet cuffs more effective at lower inflation pressures. Acta Orthop Scand. 1988 Aug;59(4):447-51. doi: 10.3109/17453678809149401.
PubMed 3421083Partsch H, Mosti G. Comparison of three portable instruments to measure compression pressure. Int Angiol. 2010 Oct;29(5):426-30.
PubMed 20924346
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Surface Pressures Under Blood-Draw Tourniquets
- ClinicalTrials.gov ID
- NCT03187041
- Acronym / sponsor ID
- 161885
- Keywords
- blood draw tourniquets, skin surface pressure, blood draw band, elastic tourniquet, phlebotomy, tourniquet pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: This research study seeks to determine whether surface pressures generated by elastic tourniquets used by phlebotomists during blood-draws can penetrate to deeper tissues where major arteries and nerves lie. Additionally, investigators will also determine the effects of prolonged tourniquet application on hand sensation using a controlled, reproducible force stimulus. In conjunction, the investigators will also track changes in skin surface pressures and pain levels over this prolonged tourniquet application. Hypothesis: The investigators hypothesize the use of common elastic tourniquets used for blood draws does not significantly impact sensation and will not elicit nerve or tissue damage. Technologies used: Monofilaments and Pressure Sensor
Detailed description
The objective of this study is to investigate the reproducibility and consequently the safety of common elastic tourniquet methods for blood draws. Specifically, the study will investigate whether the surface pressures produced by blood draw tourniquets when applied by experienced phlebotomists are significant enough to penetrate to deeper tissue near bone where major arteries and nerves lie. By relating factors including tourniquet width and patient arm circumference to our surface pressure measurements and comparing our results to previous literature, the investigators hope to determine the safety of current blood draw tourniquet procedures.
In addition, the investigators will track changes in skin surface pressures over time to determine if prolonged exposure to these tourniquet pressures has the potential to permanently affect nerve function and muscle in tissues near bone.
Hand sensation will be investigated during a prolonged tourniquet application trial of the study to test the effects of the generated pressures on median, ulnar, and radial nerve viability over time.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In order to acquire our data, a Microlab PicoPress device will be employed. It has been shown to provide accurate, linear, and reproducible measures of surface pressure between the skin and device. For tourniquets, the investigators will be using a MedSource perforated tourniquet, which is the type of elastic tourniquet the phlebotomists are accustomed to using in their daily practice. For each experiment throughout both phases of the study, the PicoPress pressure sensor will be folded in half and taped over the lateral aspect of the right arm, approximately 2 inches distal to the deltoid muscle along the brachialis muscle. Arm circumferences will be taken prior to experimentation at this same location. For each trial, the phlebotomists will tie the 2.5cm elastic tourniquet around the arm and pressure sensor while ensuring that the tourniquet is not knotted directly on top of the sensor. The study will be divided into two phases of experimentation conducted sequentially.
| Arm | Type | Receives |
|---|---|---|
| Skin surface pressures under tourniquets and sensation | Experimental | Other: Sensation and Skin Surface Pressures Under Blood-Draw TourniquetsPhase 1: Each phlebotomist will apply the tourniquet 10 separate times to the right arm of each subject. The tourniquet will remain on the arm for approximately ten seconds, to be able to allot enough time to collect an accurate pressure measurement. All 10 tourniquet skin pressure measurements will take place on the same day for a subject. Phase 2: 20 subjects will be subjected to a prolonged blood-draw tourniquet application for a duration of 1 hour. The purpose of phase 2 is to determine whether there is an effect on sensation from prolonged blood tourniquet use. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years or older
Key exclusion criteria (5 listed)
- no history of abnormal heart conditions
- no history of coagulation disorders
- will not be on prescription medications that affect cardiovascular system (ex: medications that affect blood pressure or cardiac contractility etc.)**
- does not have diabetes
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 |
|---|---|---|
| Sensation and Skin Surface Pressures Under Blood-Draw TourniquetsPhase 1: Skin surface pressures will be recorded by an investigator during each of the 10 applications of the tourniquet. All 10 tourniquet skin pressure measurements will take place in the Blood Draw clinic at the UCSD Medical Center in Hillcrest on the same day for a subject. Phase 2: The same 20 subjects will be subjected to a prolonged blood-draw tourniquet application for a duration of 70 minutes. The purpose of phase 2 is to determine whether there is an effect on sensation from prolonged blood tourniquet use. External skin pressures will not exceed 60mmHg. During this prolonged tourniquet application the investigators will monitor changes in hand sensation at 10-minute intervals using Semmes-Weinstein monofilaments on three peripheral nerves of the hand (median, radian, and ulnar). | Other | Skin surface pressures under tourniquets and sensation |
Primary outcome
Skin Surface Pressure Under Blood-Draw Tourniquet with Phlebotomists (Phase 1)
Time frame: Phase 1: 10-15 seconds (10 times within a 5 -10 minute period)
The pressure under blood draw tourniquets will be taken in Phases 1 and 2. During phase 1, the tourniquet will remain on the subject for a brief period of time (10-15 seconds) 10 times, allowing for enough time to acquire pressure measurements using the PicoPress device. The difference between Phase 1 and Phase 2 is that phase 1 will be performed with a phlebotomist, while phase 2 will be performed with one of the investigators for an extended period of time.
Skin Surface Pressure Under Blood-Draw Tourniquet and Change in sensation during a 1 hour period (Phase 2)
Time frame: Phase 2: 70 minutes (sensation will be measured every 10 minutes)
Phase 2: The PicoPress will constantly monitor pressure under the arm tourniquet for one hour. The investigators will also simultaneously monitor the changes from baseline in sensation using Semmes-Weinstein Monofilaments on the radial, ulnar, and median nerves in participants.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Background: PubMed 3421083Crenshaw AG, Hargens AR, Gershuni DH, Rydevik B. Wide tourniquet cuffs more effective at lower inflation pressures. Acta Orthop Scand. 1988 Aug;59(4):447-51. doi: 10.3109/17453678809149401.
- Background: PubMed 20924346Partsch H, Mosti G. Comparison of three portable instruments to measure compression pressure. Int Angiol. 2010 Oct;29(5):426-30.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared.
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.
Alan R Hargens, PhD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensation and Skin Surface Pressures Under Blood-Draw Tourniquets in people with Skin Pressures Under Blood Draw-tourniquets, run by University of California, San Diego 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 1 inclusion and 5 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 7 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Skin Surface Pressure Under Blood-Draw Tourniquet with Phlebotomists (Phase 1) (time frame: Phase 1: 10-15 seconds (10 times within a 5 -10 minute period)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03187041, which also lists 2 linked publications.
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 7 Feb 2020.