NCT02389725

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
3 years until next milestone

Results Posted

Study results publicly available

May 20, 2019

Completed
Last Updated

May 20, 2019

Status Verified

April 1, 2019

Enrollment Period

1.2 years

First QC Date

March 10, 2015

Results QC Date

April 22, 2019

Last Update Submit

April 22, 2019

Conditions

Keywords

peripheral intravenous accesstourniquet techniques

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Total Number of Peripheral IV Access Attempts

    baseline

  • Total Number of Distinct Providers That Attempted IV Access

    baseline

  • Rate of Rescue Techniques Used

    baseline

Study Arms (2)

disposable elastic tourniquet

ACTIVE COMPARATOR
Device: disposable elastic tourniquet

manual blood pressure cuff

ACTIVE COMPARATOR

manual blood pressure cuff inflated to 150 milliliters mercury (mmHg)

Device: blood pressure cuff

Interventions

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

disposable elastic tourniquet

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

manual blood pressure cuff

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Emergency Department patients
  • years old or older
  • who receive peripheral IV access

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related 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 Dec;37(12):2209-2214. doi: 10.1016/j.ajem.2019.03.034. Epub 2019 Mar 23.

Related Links

Results Point of Contact

Title
Dr. Tobias Kummer
Organization
Mayo Clinic

Study Officials

  • Tobias Kummer, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Emergency Medicine

Study Record Dates

First Submitted

March 10, 2015

First Posted

March 17, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 20, 2019

Results First Posted

May 20, 2019

Record last verified: 2019-04

Locations