Clinical Trial

Extubation Safety Via Microstream EtCO₂ (IPI) Monitoring

Enrolling by Invitation
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Record status
This record was last updated January 27, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to evaluate whether extubation guided by the Integrated Pulmonary Index (IPI)-a composite respiratory score derived from microstream sidestream end-tidal carbon dioxide (EtCO₂) monitoring-improves safety in adults recovering from general anesthesia in the Post-Anesthesia Care Unit (PACU). It will also assess adverse events associated with IPI-guided extubation. The main questions it aims to answer are: 1. Does IPI-guided extubation reduce the incidence of hypoxemia compared to conventional methods? 2. What adverse events (e.g., cardiovascular complications, prolonged hypoxemia) occur with IPI-guided extubation? Researchers will compare the IPI-guided group (extubated when IPI ≥8) to the conventional group (extubated per standard PACU protocols) to determine if IPI monitoring improves extubation outcomes. Participants will:Undergo elective abdominal surgery under general anesthesia with endotracheal intubation. Be randomly assigned to either: 1. Group T (IPI-guided): Receive continuous EtCO₂/IPI monitoring via an endotracheal sampling line, with extubation triggered when IPI ≥8 after spontaneous respiration resumes. 2. Group C (Conventional): Follow standard PACU extubation protocols without IPI monitoring. Have their respiratory status, adverse events (hypoxemia, cardiovascular reactions), and required interventions recorded post-extubation. Participate in satisfaction surveys (patients and PACU nurses) regarding the extubation process.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-05-15; most recent amendment 2026-01-24.
Status change: Not Yet Recruiting → Enrolling by Invitation 2026-01-24
Trial Details
NCT Number NCT06975553
Lead Sponsor Chinese PLA General Hospital
Conditions Hypoxemia
Enrollment 632 participants
Start Date 2025-06-30
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-27