TourniquetNCT02389725
The Effect of Two Different Tourniquet Techniques on Peripheral IV Access Success Rates
A study testing disposable elastic tourniquet and blood pressure cuff in people with Tourniquet, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to compare the success rates of two different tourniquets that are used when placing an IV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tourniquet
- What is being tested?
- disposable elastic tourniquet and blood pressure cuff
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jun 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Emergency Department patients
- 18 years old or older
- who receive peripheral IV access
Who cannot join
- Patients under the age of 18
- prison inmates
- pregnant patients
- patients who are unable to give informed consent
- critically ill patients who need emergent IV access as defined by the Emergency Medicine consultant of record for the patient
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The purpose of this study is to compare the success rates of two different tourniquets that are used when placing an IV.
- Conditions
- Tourniquet
- Being tested
- disposable elastic tourniquet, blood pressure cuff
- Keywords
- peripheral intravenous access, tourniquet techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disposable elastic tourniquetDevice
Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff.
blood pressure cuffDevice
Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff.
| Study group | Role | What they receive |
|---|---|---|
| disposable elastic tourniquet | Active comparator | Not described Receives: Device: disposable elastic tourniquet |
| manual blood pressure cuff | Active comparator | manual blood pressure cuff inflated to 150 milliliters mercury (mmHg) Receives: Device: blood pressure cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral IV Access Success Rate
Peripheral IV access success rate is defined as the number of subjects who had successful peripheral intravenous cannulation on the first attempt. An attempt was defined as a needle penetrating the surface of the subject's skin. Successful access was defined as good flow through an IV catheter with a saline flush and without subcutaneous fluid collection.
Measured: baseline
Secondary outcomes (3)
Total Number of Peripheral IV Access Attempts
The total number of peripheral IV access attempts for each subject., up to a maximum of four attempts. An attempt is defined as a needle penetrating the subject's skin surface.
Measured: baseline
Total Number of Distinct Providers That Attempted IV Access
Total number of individual medical providers that attempt to access IV for each subject. An attempt is defined as a needle penetrating the surface of the subject's skin. Access was defined as good flow through an IV catheter with a saline flush and without subcutaneous fluid collection.
Measured: baseline
Rate of Rescue Techniques Used
The number of subjects requiring one or more rescue techniques to access peripheral IV. These techniques include ultrasound guided peripheral IV access, central venous access, venous cut-down, interosseous access, and/or change in treatment plan due to unsuccessful access.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2016
- Study completionJun 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TourniquetStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Kummer, Mayo Clinic
- Investigators
- Tobias Kummer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389725
- Sponsor's protocol ID
- 14-007501
- Status last verified
- Apr 2019
- First submitted
- 10 Mar 2015
- Last updated
- 20 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Tran T, Lund SB, Nichols MD, Kummer T. Effect of two tourniquet techniques on peripheral intravenous cannulation success: A randomized controlled trial. Am J Emerg Med. 2019 Dec;37(12):2209-2214. doi: 10.1016/j.ajem.2019.03.034. Epub 2019 Mar 23.
PubMed 30948254
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Tourniquet Techniques on Peripheral IV Access Success Rates
- ClinicalTrials.gov ID
- NCT02389725
- Acronym / sponsor ID
- 14-007501
- Conditions
- Tourniquet
- Keywords
- peripheral intravenous access, tourniquet techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Posted 20 May 2019
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 this study is to compare the success rates of two different tourniquets that are used when placing an IV.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| disposable elastic tourniquet | Active comparator | Device: disposable elastic tourniquet |
| manual blood pressure cuff | Active comparator | Device: blood pressure cuffmanual blood pressure cuff inflated to 150 milliliters mercury (mmHg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Emergency Department patients
- 18 years old or older
- who receive peripheral IV access
Key exclusion criteria (5 listed)
- Patients under the age of 18
- prison inmates
- pregnant patients
- patients who are unable to give informed consent
- critically ill patients who need emergent IV access as defined by the Emergency Medicine consultant of record for the patient
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 |
|---|---|---|
| disposable elastic tourniquetComparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff. | Device | disposable elastic tourniquet |
| blood pressure cuffComparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff. | Device | manual blood pressure cuff |
Primary outcome
Peripheral IV Access Success Rate
Time frame: baseline
Peripheral IV access success rate is defined as the number of subjects who had successful peripheral intravenous cannulation on the first attempt. An attempt was defined as a needle penetrating the surface of the subject's skin. Successful access was defined as good flow through an IV catheter with a saline flush and without subcutaneous fluid collection.
3 secondary outcomes
Total Number of Peripheral IV Access Attempts
Time frame: baseline
Total Number of Distinct Providers That Attempted IV Access
Time frame: baseline
Rate of Rescue Techniques Used
Time frame: baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30948254Tran T, Lund SB, Nichols MD, Kummer T. Effect of two tourniquet techniques on peripheral intravenous cannulation success: A randomized controlled trial. Am J Emerg Med. 2019 Dec;37(12):2209-2214. doi: 10.1016/j.ajem.2019.03.034. Epub 2019 Mar 23.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Healthy Adults Aged 18-55, Three Ukrainian Windlass Tourniquets (SICH, DNIPRO GEN 2, PULS) Compared With CAT Gen 7, and Complete Limb Arterial Occlusion Confirmed by Doppler.
Hemorrhage, Healthy Volunteers
Not yet recruiting
Wide-Awake Local Anesthesia No-Tourniquet (WALANT) Procedures
Hand Injuries and Disorders
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Anterior Cruciate Ligament Injury
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.
Tobias Kummer, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing disposable elastic tourniquet and blood pressure cuff in people with Tourniquet, run by Mayo Clinic 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 3 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 20 May 2019. 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 20 May 2019). 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?
Peripheral IV Access Success Rate (time frame: baseline). 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 NCT02389725, which also lists 1 linked publication.
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 20 May 2019.