Back to resultsClinical Application and Validation of Innovative Tourniquet
Primary Purpose
Compartment Syndrome of Forearm
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Innovative tourniquet (Acusense Nonpneumatic tourniquet)
Sponsored by
About this trial
This is an interventional prevention trial for Compartment Syndrome of Forearm
Eligibility Criteria
Inclusion Criteria: Nurse group: We included nurses who have working experience of more than 3 months, and are willing to use an innovative tourniquet.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nurse group
Arm Description
Using an innovative tourniquet (Acusense Nonpneumatic tourniquet) for the standard of care
Outcomes
Primary Outcome Measures
Preventing the forgetting to remove the tourniquet
Forgetting to remove the tourniquet is defined as the optimal removing time to delay of one minute.
Enhancing nurses' satisfaction
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05605990
First Posted
October 25, 2022
Last Updated
October 31, 2022
Sponsor
National Cheng-Kung University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05605990
Brief Title
Clinical Application and Validation of Innovative Tourniquet
Official Title
Clinical Application and Validation of Innovative Tourniquet
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng-Kung University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Compartment Syndrome of Forearm
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
We will recruit 160 nurses in high-risk units of the hospital.
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nurse group
Arm Type
Experimental
Arm Description
Using an innovative tourniquet (Acusense Nonpneumatic tourniquet) for the standard of care
Intervention Type
Device
Intervention Name(s)
Innovative tourniquet (Acusense Nonpneumatic tourniquet)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Preventing the forgetting to remove the tourniquet
Description
Forgetting to remove the tourniquet is defined as the optimal removing time to delay of one minute.
Time Frame
A three months period
Title
Enhancing nurses' satisfaction
Description
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.
Time Frame
A three months period
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Nurse group: We included nurses who have working experience of more than 3 months, and are willing to use an innovative tourniquet.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33394637
Citation
Gorski LA, Hadaway L, Hagle ME, Broadhurst D, Clare S, Kleidon T, Meyer BM, Nickel B, Rowley S, Sharpe E, Alexander M. Infusion Therapy Standards of Practice, 8th Edition. J Infus Nurs. 2021 Jan-Feb 01;44(1S Suppl 1):S1-S224. doi: 10.1097/NAN.0000000000000396. No abstract available.
Results Reference
result
PubMed Identifier
17652690
Citation
Lee C, Porter KM, Hodgetts TJ. Tourniquet use in the civilian prehospital setting. Emerg Med J. 2007 Aug;24(8):584-7. doi: 10.1136/emj.2007.046359.
Results Reference
result
PubMed Identifier
19263937
Citation
Pinkerton C. New technology enhances expertise of vascular access team. Can Nurse. 2009 Feb;105(2):21-2. No abstract available.
Results Reference
result
PubMed Identifier
29799611
Citation
Duignan KM, Lamb LC, DiFiori MM, Quinlavin J, Feeney JM. Tourniquet use in the prehospital setting: Are they being used appropriately? Am J Disaster Med. 2018;13(1):37-43. doi: 10.5055/ajdm.2018.0286.
Results Reference
result
Learn more about this trial
Clinical Application and Validation of Innovative Tourniquet
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