Clinical trial NCT06975553: Extubation Safety Via Microstream EtCO₂ (IPI) Monitoring
Official title: Safety of the Integrated Pulmonary Index in Guiding Extubation in Post-Anesthesia Care Unit Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypoxemia
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 632
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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. 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.

Detailed description: The investigators aim to explore the safety of extubation guided by microstream sidestream End-Tidal Carbon Dioxide (EtCO2) monitoring, specifically using the Integrated Pulmonary Index (IPI). End-tidal carbon dioxide (EtCO2) monitoring is a non-invasive, simple, real-time, and continuous parameter for assessing respiratory function. Using EtCO2 monitoring to observe respiratory changes in anesthetized patients helps clinicians detect ventilation abnormalities early, ensuring patient safety during the perioperative period. This study employs micro-side-stream EtCO2 monitoring based on infrared spectroscopy, which can more accurately and stably identify patients' respiratory changes. This monitor can provide early warnings of airway obstruction and hypoxemia and is suitable for neonatal, pediatric, and adult patients in hospitals, medical institutions, and during intra-hospital transport.

The Integrated Pulmonary Index (IPI) combines four respiratory function parameters-SpO2, PETCO2, respiratory rate (RR), and pulse rate (PR)-into a simplified IPI score ranging from 1 to 10, representing different respiratory states. A score of 1 indicates severe respiratory insufficiency, while 10 represents optimal respiratory function.

Traditional criteria for extubation primarily rely on the clinical experience of anesthesiologists or nurse anesthetists to determine the appropriate timing. However, with the increasing complexity of patient conditions, anesthesiologists face significant challenges in ensuring safe and smooth extubation. Currently, there is no objective monitoring parameter to guide safe extubation. Previous studies on EtCO2-derived IPI monitoring have mostly focused on post-extubation patients in the Post-Anesthesia Care Unit (PACU). Research has shown that a decline in IPI after extubation may indicate suboptimal extubation timing, and timely intervention can effectively reduce the incidence of respiratory adverse events. For example, in patients with sleep apnea, post-extubation IPI monitoring can also reduce the occurrence of hypoxemia. Our preliminary studies have found that using this monitoring method to observe respiratory changes in elderly patients under intravenous anesthesia helps detect hypoxemia earlier. However, there is limited research on the application of IPI monitoring to guide safe extubation.

This study enrolled patients scheduled for elective abdominal surgery under general anesthesia with endotracheal intubation and admitted to the PACU, randomly dividing them into two groups: the conventional extubation group (Group C) and the IPI-monitored extubation group (Group T). Upon PACU admission, all patients were connected to monitoring devices, with the IPI group additionally equipped with an endotracheal tube-connected EtCO2 sampling line for continuous IPI monitoring, while the control group received routine monitoring. In the IPI group, after the return of spontaneous respiration, mechanical ventilation was discontinued, and extubation was performed when the IPI reached ≥8. In the control group, extubation followed the standard PACU protocol. After extubation, respiratory changes were observed in both groups, and adverse events (hypoxemia, duration of hypoxemia, cardiovascular adverse reactions) and interventions were recorded.

By comparing the incidence of hypoxemia, adverse cardiovascular events, intervention rates, and satisfaction surveys from both patients and PACU nurses between the two groups, this study aims to explore the safety of using IPI monitoring to guide extubation in PACU patients recovering from general anesthesia.

Eligibility criteria: Inclusion Criteria:

1. Patients scheduled for elective abdominal surgery (gastrointestinal surgery in general surgery, gynecology, hepatobiliary surgery, or urology) under general anesthesia with endotracheal intubation in the PACU of the First Medical Center of the PLA General Hospital between April 2025 and April 2026, with ASA classification I-III, aged ≥18 years and \<80 years, and surgical duration ≥1 hour and ≤4 hours.
2. Signed informed consent form

Exclusion Criteria:

1. Patients whose endotracheal tube had been removed before entering the PACU.
2. Patients with preoperative room-air SpO₂ \< 95%, or those who failed to enter the PACU postoperatively for any reason.
3. Patients with a history of sleep apnea.
4. Patients undergoing a second surgery within one month.
5. Patients with a history of neuromuscular dysfunction.
6. Patients with psychiatric or cognitive disorders; a history of abuse of psychotropic or anesthetic drugs; or communication barriers.
7. Patients unable to cooperate with the clinical trial.

The exclusion criteria are as follows:

1. Patients with severe arrhythmia after entering the PACU.
2. Patients whose extubation is delayed due to medical conditions (e.g., awaiting frozen section results, active bleeding, etc.) after entering the PACU.
3. Patients who require a second surgery after extubation in the PACU.-

Primary outcomes:
measure: Incidence of hypoxemia
timeFrame: immediately after extubation, 5 minutes after extubation, 10 minutes after extubation
measure: Duration of hypoxemia
timeFrame: From extubation to discharge from the PACU.
Secondary outcomes:
measure: Incidence of subclinical hypoxemia
timeFrame: immediately after extubation, 5 minutes after extubation, 10 minutes after extubation
measure: Duration of subclinical hypoxemia
timeFrame: From extubation to discharge from the PACU.
Other outcomes:
Locations:
Study officials:
affiliation: The Firsst Medical Center ,Chinese PLA General Hospital
name: Pei qi wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.