Clinical Application and Validation of Innovative Tourniquet

April 8, 2024 updated by: Chou-Ching Lin, National Cheng-Kung University Hospital

Background: Tourniquets are the basic equipment for nurses to perform blood draws, and venous indwelling needles for congestion, or for hemostasis. Therefore, forgetting to remove the tourniquet is a common problem that leads to blood circulation being blocked, and even severe tissue necrosis occurred.

Purpose: The study aimed to evaluate whether this innovative tourniquet could prevent forgetting to remove the tourniquet, and improve the satisfaction of care.

Research design: This clinical research trial was a quasi-experimental study designed for a single group with pre-and post-test. We will recruit 160 nurses in high-risk units of the hospital. The delay in removing the tourniquet as our study outcome is defined as the removing time delay of one minute.

Expected results: The research results will provide some evidence of the efficacy of intelligent tourniquets.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

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

  • Taiwan
      • Tainan, Taiwan, 722
        • National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: Nurse group: We included nurses who have working experience of more than 3 months, and are willing to use an innovative tourniquet.

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nurse group
Using an innovative tourniquet (Acusense Nonpneumatic tourniquet) for the standard of care
Device: Innovative tourniquet (Acusense Nonpneumatic tourniquet)
To use this innovative tourniquet before collecting blood samples, and setting IV catheter. We also use this innovative tourniquet to occlude the flow of blood.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preventing the forgetting to remove the tourniquet
Time Frame: A three months period
Forgetting to remove the tourniquet is defined as the optimal removing time to delay of one minute.
A three months period
Enhancing nurses' satisfaction
Time Frame: A three months period
The Likert Scale asks how much a person agrees or disagrees with a particular statement or question. It is usually made up of a 5-point rating scale ranging from 1 and 5 with 10-item.
A three months period

Collaborators and Investigators

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

Sponsor

National Cheng-Kung University Hospital

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

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 (Actual)

December 1, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

October 25, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 4, 2022

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB No.A-BR-111-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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