The Effect of Two Different Tourniquet Techniques on Peripheral IV Access Success Rates

April 22, 2019 updated by: Tobias Kummer, Mayo Clinic
The purpose of this study is to compare the success rates of two different tourniquets that are used when placing an IV.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: disposable elastic tourniquet
Device: disposable elastic tourniquet
Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff.
ACTIVE_COMPARATOR: manual blood pressure cuff
manual blood pressure cuff inflated to 150 milliliters mercury (mmHg)
Device: blood pressure cuff
Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Number of Peripheral IV Access Attempts
Time Frame: baseline
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
Total Number of Distinct Providers That Attempted IV Access
Time Frame: baseline
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
Rate of Rescue Techniques Used
Time Frame: baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

March 10, 2015

First Submitted That Met QC Criteria

March 16, 2015

First Posted (ESTIMATE)

March 17, 2015

Study Record Updates

Last Update Posted (ACTUAL)

May 20, 2019

Last Update Submitted That Met QC Criteria

April 22, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14-007501

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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