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Evaluation of AI Models in Determining the Optimal PEEP

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 4, 2025 (before its estimated February 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 24, 2025 to Mar 1, 2025
    • Site details revised
    v3
  2. Minor Re-verified, no change to tracked fieldsv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
his study is designed as a prospective observational clinical trial. Patients over 18 years old who are hemodynamically stable and require mechanical ventilation in the Intensive Care Unit (ICU) will be included. The inclusion criteria ensure that participants require individualized ventilatory optimization. The study will involve a comparison between Artificial Intelligence (AI)-generated Positive End-Expiratory Pressure (PEEP) recommendations and expert-determined PEEP levels. ICU specialists will perform PEEP titration manually based on standardized protocols, identifying the lower inflection point (LIP) and upper inflection point (UIP) to optimize ventilation. The pressure-volume (P-V) curve will be analyzed to ensure optimal alveolar recruitment and prevent overdistension. Study Procedures Participants will: Undergo systematic mechanical ventilation assessments, including inspiratory hold and expiratory hold maneuvers, compliance, elastance, auto-PEEP, and time constant evaluations. Have ventilation data collected and analyzed using three AI models: ChatGPT, DeepSeek, and Gemini. Receive AI-generated recommendations regarding optimal PEEP levels, abnormal ventilation parameters, and potential treatment suggestions. Have their AI-based PEEP recommendations compared with those determined by ICU specialists with at least five years of experience. Outcome Measures The study will compare AI and expert assessments based on the following primary and secondary measures: Primary Outcome: Agreement between AI-generated PEEP levels and expert-determined PEEP levels. Secondary Outcomes: AI sensitivity and specificity in detecting abnormal ventilation parameters. Accuracy of AI-generated diagnoses. Clinical applicability of AI-recommended treatment strategies. This study aims to determine whether AI models can serve as reliable clinical decision support tools for ventilator management in ICU patients.
Trial Details
NCT Number NCT06844916
Lead Sponsor Kanuni Sultan Suleyman Training and Research Hospital
Conditions
(from sponsor)
PEEP, Occult
Related terms Positive-Pressure Respiration, Intrinsic
Enrollment 145 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov