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ENROLLING BY INVITATION
NCT06975553
NA

Extubation Safety Via Microstream EtCO₂ (IPI) Monitoring

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

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.

Official title: Safety of the Integrated Pulmonary Index in Guiding Extubation in Post-Anesthesia Care Unit Patients: A Randomized Controlled Study

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

632

Start Date

2025-06-30

Completion Date

2026-09-30

Last Updated

2026-01-27

Healthy Volunteers

No

Conditions

Interventions

DEVICE

endotracheal intubation-type end-tidal carbon dioxide sampling tube

In addition to routine monitoring (ECG, NIBP, and SpO2), an endotracheal intubation-type end-tidal carbon dioxide sampling tube is used for end-tidal carbon dioxide IPI monitoring.

Locations (1)

Medtronic 20p

Beijing, Beijing Municipality, China