HypoxemiaNCT06975553
Extubation Safety Via Microstream EtCO₂ (IPI) Monitoring
A study testing endotracheal intubation-type end-tidal carbon dioxide sampling tube in people with Hypoxemia, run by Chinese PLA General Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypoxemia
- What is being tested?
- endotracheal intubation-type end-tidal carbon dioxide sampling tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 632 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety of the Integrated Pulmonary Index in Guiding Extubation in Post-Anesthesia Care Unit Patients: A Randomized Controlled Study
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:
Read more
- Does IPI-guided extubation reduce the incidence of hypoxemia compared to conventional methods?
- 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:
- Group T (IPI-guided): Receive continuous EtCO₂/IPI monitoring via an endotracheal sampling line, with extubation triggered when IPI ≥8 after spontaneous respiration resumes.
- 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.
Read the 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.
- Conditions
- Hypoxemia
- Being tested
- endotracheal intubation-type end-tidal carbon dioxide sampling tube
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endotracheal intubation-type end-tidal carbon dioxide sampling tubeDevice
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 group | Role | What they receive |
|---|---|---|
| Group C | No intervention | Group C:the conventional extubation group |
| Group T | Experimental | Group T:extubation group with IPI monitoring Receives: Device: endotracheal intubation-type end-tidal carbon dioxide sampling tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypoxemia
The incidence of hypoxemia in each group(%).
Measured: immediately after extubation, 5 minutes after extubation, 10 minutes after extubation
Duration of hypoxemia
Duration of hypoxemia(seconds)
Measured: From extubation to discharge from the PACU.
Secondary outcomes (2)
Incidence of subclinical hypoxemia
The incidence of subclinical hypoxemia(%)
Measured: immediately after extubation, 5 minutes after extubation, 10 minutes after extubation
Duration of subclinical hypoxemia
Duration of subclinical hypoxemia(seconds)
Measured: From extubation to discharge from the PACU.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start30 Jun 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 632 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peiqi Wang, Chinese PLA General Hospital
- Investigators
- Pei qi wang, Principal investigator, The Firsst Medical Center ,Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975553
- Sponsor's protocol ID
- PLAGH-L02
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33550546Laporta 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.
PubMed 32415817Bartels 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.
PubMed 31971921
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of the Integrated Pulmonary Index in Guiding Extubation in Post-Anesthesia Care Unit Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06975553
- Acronym / sponsor ID
- PLAGH-L02
- Conditions
- Hypoxemia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 632 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does IPI-guided extubation reduce the incidence of hypoxemia compared to conventional methods?
- 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:
- Group T (IPI-guided): Receive continuous EtCO₂/IPI monitoring via an endotracheal sampling line, with extubation triggered when IPI ≥8 after spontaneous respiration resumes.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | No intervention | –Group C:the conventional extubation group |
| Group T | Experimental | Device: endotracheal intubation-type end-tidal carbon dioxide sampling tubeGroup T:extubation group with IPI monitoring |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endotracheal intubation-type end-tidal carbon dioxide sampling tubeIn 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. | Device | Group T |
Primary outcome
Incidence of hypoxemia
Time frame: immediately after extubation, 5 minutes after extubation, 10 minutes after extubation
The incidence of hypoxemia in each group(%).
Duration of hypoxemia
Time frame: From extubation to discharge from the PACU.
Duration of hypoxemia(seconds)
2 secondary outcomes
Incidence of subclinical hypoxemia
Time frame: immediately after extubation, 5 minutes after extubation, 10 minutes after extubation
Duration of subclinical hypoxemia
Time frame: From extubation to discharge from the PACU.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 33550546Potvin 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.
- Background: PubMed 32415817Laporta 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.
- Results publication: PubMed 31971921Bartels 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pei qi wang principal investigator
The Firsst Medical Center ,Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endotracheal intubation-type end-tidal carbon dioxide sampling tube in people with Hypoxemia, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypoxemia (time frame: immediately after extubation, 5 minutes after extubation, 10 minutes after extubation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06975553, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.