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Development and Validation of Delirium Recognition Using Computer Vision in Neuro-critical Patients

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Capital Medical University

Status

Enrolling

Conditions

Delirium
Artificial Intelligence (AI)

Study type

Observational

Funder types

Other

Identifiers

NCT07136207
PX2023021

Details and patient eligibility

About

This research project employs machine learning algorithms integrated with computer vision, image processing, and pattern recognition technologies to perform digital analysis of facial expression behaviors in neurocritical care patients with delirium. By constructing multidimensional high-level features of delirium, the investigators have established a classification model based on behavioral. The primary objective of this study is to address the critical challenge of achieving precise and efficient delirium diagnosis in neurologically critically ill patients through automated facial expression behavior recognition.

Full description

This study is a prospective cohort study approved by the Ethics Committee of Beijing Tiantan Hospital. It aims to support the accurate and efficient diagnosis of delirium in neurocritical patients through a facial expression recognition system. A mobile application was developed for this study, collaboratively designed by senior clinicians and engineers from the Institute of Computing Technology, Chinese Academy of Sciences. The application is based on a stimulus paradigm designed using CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) questions to record dynamic facial videos of neurocritical patients following delirium evaluation based on the DSM-V criteria.

Patients were assessed for delirium and facial expression behavior data were collected twice daily during ICU admission, in two time slots: 8:00-10:00 AM and 8:00-10:00 PM, following the study's inclusion and exclusion criteria. A trained and experienced specialist used the gold standard DSM-V to diagnose delirium. Within five minutes after completing the assessment, dynamic facial behavior video data were collected to prepare images for subsequent model development.

Various image preprocessing and data augmentation techniques were employed to prepare the images for the VGG16 model. These techniques are standard for running convolutional neural network (CNN) models. Using the "preprocess_input"function from the Keras VGGFace module, the investigators standardized image color and size to ensure that each image met the expected input requirements for model training. For data augmentation, the investigators applied TensorFlow's "ImageDataGenerator" function to perform horizontal flipping, rotation, scaling, width and height shifting, and shearing. These augmentation techniques created a more diverse dataset, helping to prevent overfitting and improving the model's generalizability to new faces.

The investigators developed a binary classification model to identify delirium using a CNN with a pretrained backbone. The VGG16 model, based on deep learning, was adopted, leveraging transfer learning from VGGFace2, which possesses pre-existing facial feature recognition capabilities. Transfer learning allowed us to utilize prior knowledge to detect features more quickly, accurately, and with lower computational cost. The VGGFace2 model was employed for training.

Model performance was evaluated through internal validation at Beijing Tiantan Hospital and external validation at Guiyang Second People's Hospital, with metrics including accuracy, sensitivity, specificity, and F1 score. Additionally, to address the "black box" issue of machine learning, occlusion heatmap techniques were used to identify the most critical facial regions for delirium assessment, with the results visualized on a virtual face.

This model aims to support precise and efficient identification of delirium in neurocritical care units.

Enrollment

1,000 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Neurocritical patients admitted to the ICU, including postoperative neurosurgical patients, stroke patients, and those receiving ICU care due to other neurological conditions.
  2. Age over 18 years.
  3. Signed informed consent.

Exclusion criteria

  1. Age under 18 years.
  2. Persistent coma (GCS ≤ 8) within 7 days pre- and post-surgery, making delirium assessment impossible.
  3. Did not survive more than 24 hours in the ICU.
  4. Patients with facial paralysis, post-traumatic facial disfigurement, or other conditions that could significantly affect facial recognition.
  5. Exclusion of patients with severe dementia, Parkinson's disease, depression, or other conditions that might impact facial emotional expressions.

Trial design

1,000 participants in 2 patient groups

Neurocritical non-delirium patients
Description:
For neurocritical non-delirium patients, the investigators record facial expression videos, which are used during model development to compare with the facial expressions of delirium patients.
Neurocritical delirium patients
Description:
The investigators record facial expression videos of neurocritical delirium patients and perform frame sampling on the videos to analyze and extract the facial expression features specific to delirium. Based on this analysis, the investigators develop a model for delirium recognition in neurocritical patients.

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Huang Huawei, Doctoral degree

Data sourced from clinicaltrials.gov

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