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Clinical Value of an AI-Based Dynamic Early Warning System-Assisted Approach for Early Identification and Intervention of Hypoxemia Prediction in ICU Patients: A Multicenter, Prospective, Randomized, Parallel-Controlled Trial

Clinical Value of an AI-Based Dynamic Early Warning System-Assisted Approach for Early Identification and Intervention of Hypoxemia Prediction in ICU Patients: A Multicenter, Prospective, Randomized, Parallel-Controlled Trial

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128491
Enrollment
Unknown
Registered
2026-07-21
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Hypoxemia

Interventions

Experimental group:On the basis of routine ICU monitoring and management, an artificial intelligence-based dynamic early warning system for hypoxemia risk was introduced for auxiliary management. The
Control group:Patient monitoring and management were performed by clinical medical staff with ICU clinical experience, who were not involved in the development and training of the artificial intellige

Sponsors

Shanghai Pudong New Area People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged 18 years or older, with no restriction on gender. 2.Admitted to the ICU and receiving continuous vital sign monitoring (including SpO2, heart rate, respiratory rate, blood pressure, etc.). 3.Expected ICU stay of no less than 24 hours, allowing continuous monitoring of hypoxia risk. 4.No persistent hypoxia at enrollment (SpO2 >= 93% or stable with simple oxygen therapy). 5.Qualified vital sign monitoring data available for real-time analysis by the AI system. 6.Written informed consent obtained from the patient or their legal representative.

Exclusion criteria

Exclusion criteria: 1.Presence of persistent severe hypoxia at enrollment (e.g., sustained SpO2 < 93% or requiring immediate respiratory support). 2.Receiving stable mechanical ventilation with no room for ventilator adjustment in the short term. 3.Expected ICU stay of less than 24 hours or pending ICU transfer. 4.Patients with end-stage diseases or for whom active treatment has been discontinued. 5.Severe missing data or unstable vital sign acquisition via monitoring devices. 6.Participation in other interventional clinical trials that may affect the primary endpoint of this study. 7.Other conditions deemed inappropriate for enrollment by the investigators.

Design outcomes

Primary

MeasureTime frame
SpO2;Respiratory rate;Heart rate;Blood pressure;

Countries

China

Contacts

Public ContactWan Jian

Shanghai Pudong New Area People's Hospital

wanjian@shpdph.cn+86 136 2198 1306

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026