跳至主要内容
临床试验/NCT06636604
NCT06636604已完成不适用

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

Sakarya University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Pain conditions of the patients after the injection will be determined.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •Excluded were individuals who did not meet the inclusion criteria.

研究组 & 干预措施

Experimental Group

Experimental

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

干预措施: DSA(Decision Support Algorithm) (Other)

Control Group

No Intervention

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

结局指标

主要结局

Pain conditions of the patients after the injection will be determined.

时间窗: 15 minutes

The patient marks his or her pain on a 10 cm ruler, on one end of which the painlessness is

Pain conditions of the patients after the injection will be determined.

时间窗: Baseline

The patient marks his or her pain on a 10 cm ruler, on one end of which the painlessness is written, and on the other end, the most severe possible pain is written.

次要结局

  • The patients' satisfaction levels after the injection will be determined.(15 minutes)
  • The patients' satisfaction levels after the injection will be determined.(Baseline)

研究者

发起方
Sakarya University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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