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The feasibility and effectiveness of AI technology in guiding precise prone position ventilation in patients with acute respiratory distress syndrome (ARDS) based on lung CT images-a non-inferiority prospective single-center randomized controlled trial

The feasibility and effectiveness of AI technology in guiding precise prone position ventilation in patients with acute respiratory distress syndrome (ARDS) based on lung CT images-a non-inferiority prospective single-center randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093419
Enrollment
Unknown
Registered
2024-12-04
Start date
2025-01-01
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Acute Respiratory Distress Syndrome

Interventions

Experimental group (AI group):Receiving precise prone position ventilation based on AI algorithm or software (AI group)
Contral group:Traditional prone position ventilation

Sponsors

Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients who provided written informed consent; 2.ICU patients who were 18 years or older; 3.Patients with ARDS treated with endotracheal intubation and mechanical ventilation for less than 7 days; 4.Moderate-to-severe acute respiratory distress syndrome (defined as moderate-to-severe ARDS: Pao2:Fio2=5 cmH2O, radiographic evidence of bilateral pulmonary infiltrates, and respiratory failure not explained by heart failure or fluid overload (as defined by Berlin criteria); 5.The patients were judged not likely to be weaned from the ventilator and extubated within 48h.

Exclusion criteria

Exclusion criteria: 1.The patients had contraindications to the prone position:a. Intracranial pressure > 30 mmHg or cerebral perfusion pressure < 60 mmHg b. Massive hemoptysis requiring immediate surgical or interventional surgery c. Tracheal surgery or sternotomy within the previous 15 days d. Severe facial trauma or facial surgery within the previous 15 days e. Treatment of deep vein thrombosis for less than 2 days f Built-in pacemaker in the last 2 days g. Fracture of the spine, femur or pelvis h . Mean arterial pressure less than 65 mmHg I . Pregnant women j. Chest drain leakage; 2.Reason for respiration: a. Use inhaled nitric oxide (NOi) before inclusion. b.Use extracorporeal membrane oxygenation (ECMO) before inclusion; 3.Clinical background:a.Chronic respiratory disease (pulmonary fibrosis or COPD) requiring long-term oxygen therapy; b. Burns of more than 20% of body surface; c. Underlying diseases with life expectancy of less than one year; d. Lung transplantation; 4.The patients were judged likely to die within 24 hours; 5.The patients had been enrolled in other randomized controlled clinical studies.

Design outcomes

Primary

MeasureTime frame
Oxygenation index within 7 days of enrollment;

Secondary

MeasureTime frame
Intra-abdominal pressure within 7 days of enrollment;Arterial blood gas analysis within 7 days of enrollment;Ventilator parameters and respiratory mechanics;haemodynamics;Average daily sputum drainage volume;MV-free days during 28 days after enrollment;28-day mortality rate;ICU-free days during 28 days after enrollment;Successful extubation rate;Pulmonary CT imaging changes;The incidence of complications;Implementation of enteral nutrition;

Countries

China

Contacts

Public ContactJianfeng Duan, Wenkui Yu

Drum Tower Hospital

1763462517@qq.com+86 15850783397

Outcome results

None listed

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