Clinical Application and Validation of Innovative Tourniquet

NCT05605990 | Completed DMC

• 1 other identifier: IRB No.A-BR-111-011
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Compartment Syndrome of Forearm

Outcome Measures

Primary Outcomes (2)

• Preventing the forgetting to remove the tourniquet

  Forgetting to remove the tourniquet is defined as the optimal removing time to delay of one minute.

  A three months period

• 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.

  A three months period

Study Arms (1)

Nurse group

EXPERIMENTAL

Using an innovative tourniquet (Acusense Nonpneumatic tourniquet) for the standard of care

Device: Innovative tourniquet (Acusense Nonpneumatic tourniquet)

Interventions

Innovative tourniquet (Acusense Nonpneumatic tourniquet) DEVICE

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.

Nurse group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

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

Tainan, 722, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 33394637 RESULT

• 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.

  PMID: 17652690 RESULT

• Pinkerton C. New technology enhances expertise of vascular access team. Can Nurse. 2009 Feb;105(2):21-2. No abstract available.

  PMID: 19263937 RESULT

• 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.

  PMID: 29799611 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: We will recruit 160 nurses in high-risk units of the hospital.

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 4, 2022
• Study Start: December 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

TW (1)