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Machine Learning-Based Hypoxia Risk Early Warning System for Painless Digestive Endoscopy Examination: A Multicenter Clinical Study

Machine Learning-Based Hypoxia Risk Early Warning System for Painless Digestive Endoscopy Examination: A Multicenter Clinical Study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500102688
Enrollment
Unknown
Registered
2025-05-19
Start date
2025-05-23
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory system diseases

Interventions

Case series:None

Sponsors

The Second Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18 to 75 years old. 2. The American Society of Anesthesiologists (ASA) physical status classification is <= Grade III, and the patient needs to undergo painless digestive endoscopy. 3. The patient provides informed consent, is willing to participate in the study, and agrees to provide relevant data.

Exclusion criteria

Exclusion criteria: 1. History of goiter or thyroid surgery, 2. History of other neck surgeries, 3. Severe cardiovascular cerebrovascular or pulmonary diseases, 4. Severe renal or hepatic dysfunction, 5. Neurocognitive or psychiatric disorders, 6. Epilepsy or epileptic seizures, 7. Preoperative use of sedatives or analgesics, 8. Examiners who are pregnant or breastfeeding, 9. Allergy to anesthetic drugs, 10. Subjects who refuse or are unable to cooperate with the study protocol.

Design outcomes

Primary

MeasureTime frame
During the examination process, the finger pulse oxygen saturation (SpO2) is less than 92%, and the duration is longer than 10 seconds;

Secondary

MeasureTime frame
Neck circumference;Neck length;American Society of Anesthesiologists Physical Status Classification;Mallampati airway classification;Baseline blood pressure;Baseline eart rate;Baseline Pulse oximetry saturation;The incidence of hypoxemia (SpO2 <= 90%) during the examination process, and the lowest value of SpO2 (with a duration of more than 10 seconds);

Countries

China

Contacts

Public ContactZhu Jiang

Department of Anesthesiology, The Second Affiliated Hospital of Soochow University

zhujiangsz@126.com+86 139 6215 3438

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026