Extubation Safety Via Microstream EtCO₂ (IPI) Monitoring

Enrolling by invitation · Not applicable

Conditions studied: Hypoxemia

In brief

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.

Key facts

Study ID: NCT06975553
Run by: Chinese PLA General Hospital
People needed: 632
Starts: 2025-06-30
Expected to finish: 2026-09-30
Last updated by the study team: 2026-01-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients aged 18 years and above and under 80 years old, with ASA classification of I - III, who received general anesthesia and tracheal intubation at the anesthesia recovery unit (PACU) of multiple centers such as the First Medical Center of the Chinese People's Liberation Army General Hospital, and planned for elective abdominal surgery (including digestive system surgeries in general surgery, gynecological surgeries, hepatobiliary surgeries, or urological surgeries), with a surgery duration of 1 hour or more and less than 4 hours, during the period from April 2025 to April 2026.
Have signed the informed consent form.

You may not qualify if…

Patients whose tracheal intubation was removed before entering the anesthesia recovery room.
Patients with preoperative indoor air oxygen saturation (SpO₂) lower than 95%, or those who failed to enter the anesthesia recovery room due to any reason after surgery.
Patients with a history of sleep apnea.
Patients who have undergone two surgeries within one month.
Patients with a history of neuromuscular dysfunction.
Patients with mental or cognitive disorders; those with a history of abuse of psychotropic or anesthetic drugs; or those with communication disorders.
Patients who cannot cooperate with the clinical trial.
Exclusion criteria as follows:
Patients who developed severe arrhythmia after entering the anesthesia recovery room.
Patients who were delayed in extubation after entering the anesthesia recovery room due to medical conditions (such as waiting for frozen section results, experiencing massive bleeding, etc.).
Patients who required another surgery after extubation in the anesthesia recovery room.

Where it is running

Medtronic 20p — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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