Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636604
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-03-01
Brief Title:
Development of a Decision Support Algorithm DSA for Detecting the Sciatic Nerve in Safe Injection Practices
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development of a Decision Support Algorithm DSA for Detecting the Sciatic Nerve in Safe Injection Practices
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Nursiatic
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 projectdeveloped 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
In the first phase of the projectdeveloped 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 models 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
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 models 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None