Development of a Decision Support Algorithm (DSA) for Detecting the Sciatic Nerve in Safe Injection Practices

NCT ID: NCT06636604

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-11-01

Brief Summary

This project aims to develop an artificial intelligence-based decision support algorithm (DSA) for the detection of the sciatic nerve in safe intramuscular injection applications.

In the first phase of the project,developed an artificial intelligence-based decision support algorithm (DSA) for the detection of the sciatic nerve in safe intramuscular injection applications.

In the second phase of the project, with the integration of the Decision Support Algorithm (DSA) on a computer accompanied by a doctor and an engineer, the presence of the sciatic nerve was tested on 30 volunteers. The test resulted in achieving a 100% sciatic nerve image, confirming the reliability of the DSA.

Subsequently, information about the algorithm was provided to volunteers and nurses in the emergency department of Sakarya Training and Research Hospital who applied for intramuscular injection.

Detailed Description

This project aims to develop an artificial intelligence-based decision support algorithm (DSA) for the detection of the sciatic nerve in safe intramuscular injection applications.

Method This project was conducted between 01-05-2022 and 01-11-2023.

Data Collection Phase In the first phase of the project, approximately 1500 ultrasound images of the sciatic nerve were obtained from 50 volunteers in right and left positions. Subsequently, the sciatic nerve was labeled on these images. The dimensions of the collected data were normalized, noise reduction was applied, histogram equalization was performed, and class imbalance was addressed by balancing the data. The data were further augmented by applying techniques such as rotation, translation, reflection, and zooming. The YOLOv7 model was chosen for model selection. Parameter optimization was performed for YOLOv7, and preprocessing and data augmentation processes were completed for training the model. The hyperparameters of the YOLOv7 model were manually adjusted, followed by the use of automatic hyperparameter tuning tools, significantly enhancing the model's performance.

Integration and Testing Phase of the DSA In the second phase of the project, with the integration of the Decision Support Algorithm (DSA) on a computer accompanied by a doctor and an engineer, the presence of the sciatic nerve was tested on 30 volunteers subjects based on signals received through a USG probe.

Clinical Trial Phase Subsequently, information about the algorithm was provided to volunteers and nurses in the emergency department of Sakarya Training and Research Hospital who applied for intramuscular injection. Under the supervision of volunteer nurses, project coordinators, and researchers, injections were administered to 30 patients using the DSA and to 30 patients using the traditional method. After completing the injections, nurses filled out and signed the "System Usability Scale" (SUS). Additionally, the "Visual Pain Scale" and "Satisfaction Visual Scale for Injections" were used to assess patients' pain after the injection. Pain levels of volunteer patients were compared immediately after injection and 15 minutes later.

Keywords Nurse, sciatic nerve, decision support algorithm.

Conditions

Nurses; Injection Site; Sciatic Nerve; Pain; Satisfaction, Patient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental Group

Experimental Group: The effect of the decision support algorithm on pain and satisfaction during intramuscular injection will be examined.

Group Type: EXPERIMENTAL

DSA(Decision Support Algorithm)

Intervention Type: OTHER

Intramuscular injection will be given to 30 volunteer patients using the decision support algorithm.

Control Group

There is no intervention. Pain and satisfaction during intramuscular injection will be examined.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

DSA(Decision Support Algorithm)

Intramuscular injection will be given to 30 volunteer patients using the decision support algorithm.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• The participant volunteered to take part in the research and is over 18 years of age.
• They have applied to the emergency department for an intramuscular injection and have not experienced any injection-related complications before.
• There is no risk of developing complications during the injection phase, such as bleeding, coagulation disorders, or drug allergy.
• Additionally, there is no scarring or abscess at the injection site.
• There should be no communication barriers, such as a psychological disorder or inability to speak Turkish.
• To participate in this study, it is necessary to be able to read and sign the informed consent form in Turkish.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Sakarya University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Işık ATASOY, MsC

Role: PRINCIPAL_INVESTIGATOR

Sakarya University

Locations

Sakarya University

Sakarya, Serdivan, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IŞIK ATASOY

Identifier Type: -

Identifier Source: org_study_id