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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02389725
Other study ID # 14-007501
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2015
Est. completion date June 2016

Study information

Verified date April 2019
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the success rates of two different tourniquets that are used when placing an IV.


Recruitment information / eligibility

Status Completed
Enrollment 121
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Emergency Department patients

- 18 years old or older

- who receive peripheral IV access

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
disposable elastic tourniquet
Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff.
blood pressure cuff
Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Mar 23. pii: S0735-6757(19)30183-4. doi: 10.1016/j.ajem.2019.03.034. [Epub ahead — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline
Secondary 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. baseline
Secondary 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. baseline
Secondary 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. baseline
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Terminated NCT04402775 - Brachiocephalic Arteriovenous Fistulae: Two Different Techniques of Bloodless Surgery and Their Effect on Fistula Stenosis. N/A

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