Clinical trial NCT06726551: AI Recognition of Important Structures in Otolaryngological Surgery
Official title: AI Recognition of Important Structures in Otolaryngological Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Otolaryngological Diseases Requiring Mastoidectomy
Middle Ear Surgery, Endolymphatic Sac Surgery, Cochlear Implant, Labyrinthectomy, Petrous Apex Lesions, Facial Nerve Surgery, and Lateral Skull Base Tumors
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: otolaryngological diseases requiring mastoidectomy

Brief summary: Developing a system for artificial intelligence to recognize anatomical landmarks in otolaryngological surgery, enabling real-time tracking of critical temporal bone structures during surgery.

Detailed description: Take the example of the Al recognition and prediction of the incus, external semicircular canal, facial nerve, and facial nerve recess. Within the defined surgical area, annotated data points are utilized to identify and segment the incus and the lateral semicircular canal based on their relative positions and angles concerning the posterior wall of the external auditory canal and the surrounding tissues. Detailed descriptions of the incus and lateral semicircular canal within the surgical area include: Incus: The incus is a small anvil-shaped bone located in the middle ear. It connects to the malleus laterally and the stapes medially. Identifying the incus accurately is crucial due to its proximity to the facial nerve and its involvement in the ossicular chain that transmits sound vibrations. Lateral Semicircular Canal: This is one of the three semicircular canals in the inner ear, oriented horizontally. It is involved in detecting rotational movements of the head. Proper identification is necessary to avoid damaging the canal, which could result in vertigo or balance issues. Input features include further contrast adjustment and localized magnification of images. The enhanced images are classified and localized using the trained model, and the consistency of multiple frames is utilized to determine the final positions of the facial nerve and the facial recess. Statistical analysis is conducted to predict the positions of the facial recess relative to the incus and lateral semicircular canal, providing reference information for surgeons. The system continuously monitors changes in the surgical area, offering dynamic feedback and optimizing the model's accuracy and robustness through incremental training.

Eligibility criteria: Inclusion Criteria:

1. Performing otolaryngological surgeries such as cochlear implantation, endolymphatic sac decompression, semicircular canal plugging, and acoustic neuroma surgery using a microscope.
2. Microscopic exposure provides a comprehensive and clear view of the surgical area within the temporal bone.

Exclusion Criteria:

1. No surgical video recording available.
2. Unclear visualization of the surgical area during microscopic otolaryngological procedures.
3. Incomplete visualization of the entire surgical process.
4. Patients who did not undergo high-resolution temporal bone CT at our hospital or Shenzhen Deep Bay Hospital.

Primary outcomes:
measure: otolaryngological diseases requiring mastoidectomy
timeFrame: 1 week from admission to discharge
measure: Relevant indicators to evaluate the accuracy of the model
timeFrame: From enrollment to the end of the study
Secondary outcomes:
measure: Relevant indicators of other evaluation models
timeFrame: From enrollment to the end of the study
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
state: Guangdong
Study officials:
References: