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Clinical Trials in China / NCT06975553
Enrolling by invitation Not applicable

Extubation Safety Via Microstream EtCO₂ (IPI) Monitoring

NCT06975553 · tracked via the Priya Life Science China tracker
Sponsor
Chinese PLA General Hospital
Phase
Not applicable
Started
2025-06-30
Last updated
2026-01-27

Condition(s) studied

Hypoxemia

Investigational drug(s) / intervention(s)

endotracheal intubation-type end-tidal carbon dioxide sampling tube

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion criteria: 1. 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. 2. Have signed the informed consent form. Exclusion criteria: 1. Patients whose tracheal intubation was removed before entering the anesthesia recovery room. 2. 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. 3. Patients with a history of sleep apnea. 4. Patients who have undergone two surgeries within one month. 5. Patients with a history of neuromuscular dysfunction. 6. Patients with mental or cognitive disorders; those with a history of abuse of psychotropic or anesthetic drugs; or those with communication disorders. 7. Patients who cannot cooperate with the clinical trial. Exclusion criteria as follows: 1. Patients who developed severe arrhythmia after entering the anesthesia recovery room. 2. 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.). 3. Patients who required another surgery after extubation in the anesthesia recovery room.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Medtronic 20p Beijing Beijing Municipality

More Chinese PLA General Hospital trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06975553 on ClinicalTrials.gov ↗ ← All trials in China