Data Management and Ethics

Poor-quality recordings with unreliable blood pressure or rSO2 data are excluded. Ethical approval was granted in January 2025 by the Ethics Committee of the University of South China. The study uses a web-based electronic database and offline cleaning of high-resolution intraoperative signals. Study data are deidentified and stored securely. A safety protocol requires notification of the clinical care team when participants report acute distress or suicidal ideation during assessments. Human DNA incidentally co-extracted from swabs will not be used for genetic analysis. An independent Data Safety and Monitoring Board reviews the trial annually. Self-report data are stored in a HIPAA-compliant secure university folder, with identifiers stored separately. Potentially related serious adverse events must be reported to the IRB and NICHD project officer within 48 hours. The principal investigator may suspend the trial if an adverse event poses risk to participants or is causally related to ICURA. The trial is considered low risk and does not require a separate data and trial monitoring committee. Consent informs participants that text messages have limited security and may be visible…