Extubation Safety Via Microstream EtCO₂ (IPI) Monitoring

NCT06975553 | Enrolling By Invitation

• 1 other identifier: PLAGH-L02
• Study Type: interventional
• Target: 632
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does IPI-guided extubation reduce the incidence of hypoxemia compared to conventional methods?
2. 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.
3. 3.Group T (IPI-guided): Receive continuous EtCO₂/IPI monitoring via an endotracheal sampling line, with extubation triggered when IPI ≥8 after spontaneous respiration resumes.
4. 4.Group C (Conventional): Follow standard PACU extubation protocols without IPI monitoring.

Conditions

Hypoxemia

Outcome Measures

Primary Outcomes (2)

• Incidence of hypoxemia

  The incidence of hypoxemia in each group(%).

  immediately after extubation, 5 minutes after extubation, 10 minutes after extubation

• Duration of hypoxemia

  Duration of hypoxemia(seconds)

  From extubation to discharge from the PACU.

Secondary Outcomes (2)

• Incidence of subclinical hypoxemia

  immediately after extubation, 5 minutes after extubation, 10 minutes after extubation

• Duration of subclinical hypoxemia

  From extubation to discharge from the PACU.

Study Arms (2)

Group C

NO INTERVENTION

Group C：the conventional extubation group

Group T

EXPERIMENTAL

Group T：extubation group with IPI monitoring

Device: endotracheal intubation-type end-tidal carbon dioxide sampling tube

Interventions

endotracheal intubation-type end-tidal carbon dioxide sampling tube DEVICE

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.

Group T

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Medtronic 20p

Beijing, Beijing Municipality, China

Location

Related Publications (3)

• Potvin J, Etchebarne I, Soubiron L, Biais M, Roullet S, Nouette-Gaulain K. Effects of capnometry monitoring during recovery in the post-anaesthesia care unit: a randomized controlled trial in adults (CAPNOSSPI). J Clin Monit Comput. 2022 Apr;36(2):379-385. doi: 10.1007/s10877-021-00661-9. Epub 2021 Feb 7.

  PMID: 33550546 BACKGROUND

• Laporta ML, Sprung J, Weingarten TN. Respiratory depression in the post-anesthesia care unit: Mayo Clinic experience. Bosn J Basic Med Sci. 2021 Apr 1;21(2):221-228. doi: 10.17305/bjbms.2020.4816.

  PMID: 32415817 BACKGROUND

• Bartels K, Kaizer A, Jameson L, Bullard K, Dingmann C, Fernandez-Bustamante A. Hypoxemia Within the First 3 Postoperative Days Is Associated With Increased 1-Year Postoperative Mortality After Adjusting for Perioperative Opioids and Other Confounders. Anesth Analg. 2020 Aug;131(2):555-563. doi: 10.1213/ANE.0000000000004553.

  PMID: 31971921 RESULT

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pei qi wang

  The Firsst Medical Center ,Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 16, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 27, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)