Elderly PatientsNCT07652385
Transnasal Microstream EtCO2 Reduces Hypoxemia During Emergence in Aged Post-Abdomen Surgery
A study testing EtCO₂ Monitoring and Routine Monitoring in people with Elderly Patients and Laparoscopic Surgery, run by Jianbo Wu.
Trial summary
This prospective, randomized controlled study aims to investigate whether transnasal microstream end-tidal carbon dioxide (EtCO₂) monitoring in the post-anesthesia care unit (PACU) reduces the incidence of postoperative hypoxemia in elderly patients (65-80 years, ASA I-III, BMI 18-30 kg/m²) undergoing elective… Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly Patients, Laparoscopic Surgery, Postoperative Hypoxemia
- What is being tested?
- EtCO₂ Monitoring and Routine Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Oct 2028
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65-80 years;
- ASA physical status I-III;
- BMI 18-30 kg/m²;
- Participants scheduled for elective laparoscopic surgery under general anesthesia with endotracheal intubation;
- Willing to participate in the study and provide written informed consent
Who cannot join
- Patients with nasal bleeding, nasal mucosal injury, nasal cavity occupancy, or other conditions that preclude transnasal carbon dioxide monitoring;
- Patients undergoing emergency surgery;
- Participants requiring postoperative assisted ventilation via endotracheal intubation or tracheostomy;
- Presence of any disease or condition that may cause abnormal end-tidal carbon dioxide waveforms or abnormal baseline pulse oximetry (e.g., congenital heart disease or chronic lung disease);
- Severe cardiac insufficiency (≤4 Metabolic Equivalents [MetS]);
- Severe renal insufficiency (acute kidney injury [AKI] or chronic kidney disease [CKD] stage 4 or higher);
Show all 11Show fewer
- Severe hepatic insufficiency (Child-Pugh class C or worse);
- Allergy to study medications;
- Daily alcohol intake ≥60 grams;
- History of psychiatric disorders such as depression, severe central nervous system depression, Parkinson's disease, basal ganglion lesions, schizophrenia, epilepsy, Alzheimer's disease;
- Participation in another related clinical study within the past 3 months.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Transnasal Microstream Capnography on Incidence of Hypoxemia During Emergence From General Anesthesia in Elderly Patients After Abdominal Surgery: A Prospective Randomised Controlled Trial
This prospective, randomized controlled study aims to investigate whether transnasal microstream end-tidal carbon dioxide (EtCO₂) monitoring in the post-anesthesia care unit (PACU) reduces the incidence of postoperative hypoxemia in elderly patients (65-80 years, ASA I-III, BMI 18-30 kg/m²) undergoing elective laparoscopic surgery under general anesthesia with endotracheal intubation. A total of 324 patients will be randomized 1:1 to either the control group (standard SpO₂ monitoring and clinical observation with oxygen delivery at 2 L/min via sampling line) or the experimental group (same oxygen delivery plus continuous real-time transnasal microstream EtCO₂ monitoring). The primary outcome is the incidence of hypoxemia (SpO₂ < 90% for >15 seconds) after extubation in the PACU. Secondary outcomes include severe hypoxemia (SpO₂ < 85%), lowest SpO₂ during PACU stay, vital signs at specified time points, PACU length of stay, and other adverse events. Statistical analysis will use chi-square or Fisher's exact test for the primary outcome, with a sample size calculated to detect a reduction in hypoxemia from 33% (control) to 18% (experimental group) (α=0.05, power=80%, plus 20% dropout).
Read the detailed description
Study Title:
Effect of Transnasal Microstream End-Tidal Carbon Dioxide Monitoring on the Incidence of Postoperative Hypoxemia in Elderly Patients Undergoing Laparoscopic Surgery under General Anesthesia with Endotracheal Intubation: A Prospective, Randomized Controlled Study
Principal Investigator: Wu Jianbo Department: Anesthesiology and Perioperative Medicine
Background \& Objective:
Postoperative hypoxemia is a common respiratory complication in the post-anesthesia care unit (PACU). Conventional pulse oximetry (SpO₂) has a delayed response to hypoventilation, especially during supplemental oxygen therapy. This study aims to investigate whether adding transnasal microstream end-tidal carbon dioxide (EtCO₂) monitoring in the PACU reduces the incidence of hypoxemia in elderly patients after laparoscopic surgery under general anesthesia.
Study Design:
Prospective, randomized, controlled, interventional study.
Participants:
324 elderly patients (age 65-80 years, ASA I-III, BMI 18-30 kg/m²) scheduled for elective laparoscopic surgery under general anesthesia with endotracheal intubation.
Interventions:
Control group (n=162): Routine monitoring with SpO₂ and clinical observation; oxygen delivery at 2 L/min via sampling line without EtCO₂ monitoring.
Experimental group (n=162): Same oxygen delivery plus continuous real-time transnasal microstream EtCO₂ monitoring.
Primary Outcome:
Incidence of postoperative hypoxemia (SpO₂ < 90% for >15 seconds) after extubation in the PACU.
Secondary Outcomes:
Incidence of severe hypoxemia (SpO₂ < 85% for >15 seconds) Lowest SpO₂ during PACU stay Vital signs at predefined time points
PACU length of stay (Steward Recovery Score ≥ 4)
Other adverse events (e.g., nausea, vomiting, agitation, shivering)
Safety Monitoring:
Device-related adverse events (nasal irritation, bleeding), respiratory events (bradypnea, apnea, airway obstruction), and serious adverse events (e.g., need for advanced airway, cardiovascular events) will be recorded and managed according to a stepwise intervention protocol.
Randomization and Blinding:
1:1 randomization using block randomization (SAS 9.4) with allocation concealment (sealed, opaque envelopes). Partial blinding: participants, outcome assessors, and statisticians blinded; anesthesiologists/operators unblinded.
Sample Size Calculation:
Based on pilot data (expected hypoxemia rate: 33% in control vs. 18% in experimental group), α=0.05, power=80%, plus 20% dropout → 162 patients per group (total N=324).
Statistical Analysis:
SPSS 22.0 will be used. Continuous variables (normal distribution) will be compared using t-test; non-normally distributed variables using Mann-Whitney U test. Categorical variables (e.g., hypoxemia incidence) will be compared using chi-square or Fisher's exact test.
Expected Significance:
This study will provide high-level evidence on whether transnasal microstream EtCO₂ monitoring in the PACU can enhance respiratory safety in elderly patients recovering from laparoscopic surgery, potentially reducing hypoxemia and related complications.
- Being tested
- EtCO₂ Monitoring, Routine Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtCO₂ MonitoringDevice
After extubation, the sampling line is placed between the patient's mouth and nose to deliver oxygen at 2 L/min. The sampling line is connected to a patient monitor (RespArrayTM) to initiate continuous real-time transnasal microstream end-tidal carbon dioxide (EtCO₂) monitoring throughout the post-anesthesia care unit (PACU) stay.
Routine MonitoringOther
After extubation, the sampling line is placed between the patient's mouth and nose to deliver oxygen at 2 L/min. The patient receives routine monitoring including continuous pulse oximetry (SpO₂) and clinical observation, but is not connected to the EtCO₂ monitoring device.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Routine Monitoring Group) | Active comparator | After endotracheal extubation, the sampling end of the sampling line is placed between the patient's mouth and nose, and oxygen is delivered at 2 L/min via the sampling line. The patient receives only routine monitoring (including continuous pulse oximetry and clinical observation) and is not connected to the end-tidal carbon dioxide (EtCO₂) monitoring device. Receives: Other: Routine Monitoring |
| Experimental Group (EtCO₂ Monitoring Group) | Experimental | After endotracheal extubation, the sampling end of the sampling line is placed between the patient's mouth and nose, and oxygen is delivered at 2 L/min via the sampling line. At the same time, the sampling line is connected to the monitor to initiate continuous real-time transnasal microstream end-tidal carbon dioxide monitoring. Receives: Device: EtCO₂ Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-extubation hypoxemia (SpO₂ < 90% for >15 seconds)
Closely monitor vital signs, and record the number of episodes of hypoxemia (defined as SpO₂ < 90% lasting for >15 seconds) following tracheal extubation after the patient is transferred from the operating room to the PACU.more than 15 seconds
Measured: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
Secondary outcomes (7)
Incidence of severe hypoxemia: proportion of patients with SpO₂ < 85% lasting > 15 seconds
Closely monitor the patient's vital signs, and record the proportion of patients with severe hypoxemia (SpO₂ < 85% lasting >15 seconds) following tracheal extubation after transfer from the operating room to the PACU
Measured: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
Lowest SpO₂ value during PACU stay Lowest SpO₂ value during PACU stay Lowest SpO₂ value during PACU stay
Observe and record the lowest SpO₂ value during the patient's stay in the PACU
Measured: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
PACU length of stay
time from entering the PACU until achieving a Steward recovery score >4, meeting the criteria for discharge
Measured: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
Other adverse events
Record adverse events occurring during the entire PACU stay
Measured: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
Record the changes in heart rate following the patient's admission to the PACU
Record the patient's heart rate at T0 (on PACU admission), T1 (1 min post-extubation), T2 (5 min post-extubation), T3 (10 min post-extubation), T4 (15 min post-extubation), T5 (20 min post-extubation), and T6 (on PACU discharge)
Measured: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
Record the patient's blood pressure after admission to the PACU
Record the patient's blood pressure values at T0 (on PACU admission), T1 (1 min post-extubation), T2 (5 min post-extubation), T3 (10 min post-extubation), T4 (15 min post-extubation), T5 (20 min post-extubation), and T6 (on PACU discharge)
Measured: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
Record the changes in the patient's SpO₂ values after admission to the PACU
Record the patient's SpO₂ values at T0 (on PACU admission), T1 (1 min post-extubation), T2 (5 min post-extubation), T3 (10 min post-extubation), T4 (15 min post-extubation), T5 (20 min post-extubation), and T6 (on PACU discharge)
Measured: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PatientsStudies of the same condition, open and under way.
- 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
- Model description
- Participants are randomly assigned in a 1:1 ratio to either the experimental group (transnasal microstream end-tidal carbon dioxide monitoring) or the control group (conventional monitoring with oxygen delivery only, without EtCO₂ monitoring).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianbo Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianbo Wu, Qianfoshan Hospital
- Investigators
- Jianbo WU, Doctoral, Principal investigator, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652385
- Sponsor's protocol ID
- YXLL-KY-2026(147)
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transnasal Microstream Capnography on Incidence of Hypoxemia During Emergence From General Anesthesia in Elderly Patients After Abdominal Surgery: A Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07652385
- Acronym / sponsor ID
- YXLL-KY-2026(147)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Jianbo WuUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 17 Jun 2026 (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.
This prospective, randomized controlled study aims to investigate whether transnasal microstream end-tidal carbon dioxide (EtCO₂) monitoring in the post-anesthesia care unit (PACU) reduces the incidence of postoperative hypoxemia in elderly patients (65-80 years, ASA I-III, BMI 18-30 kg/m²) undergoing elective laparoscopic surgery under general anesthesia with endotracheal intubation. A total of 324 patients will be randomized 1:1 to either the control group (standard SpO₂ monitoring and clinical observation with oxygen delivery at 2 L/min via sampling line) or the experimental group (same oxygen delivery plus continuous real-time transnasal microstream EtCO₂ monitoring). The primary outcome is the incidence of hypoxemia (SpO₂ < 90% for >15 seconds) after extubation in the PACU. Secondary outcomes include severe hypoxemia (SpO₂ < 85%), lowest SpO₂ during PACU stay, vital signs at specified time points, PACU length of stay, and other adverse events. Statistical analysis will use chi-square or Fisher's exact test for the primary outcome, with a sample size calculated to detect a reduction in hypoxemia from 33% (control) to 18% (experimental group) (α=0.05, power=80%, plus 20% dropout).
Detailed description
Study Title:
Effect of Transnasal Microstream End-Tidal Carbon Dioxide Monitoring on the Incidence of Postoperative Hypoxemia in Elderly Patients Undergoing Laparoscopic Surgery under General Anesthesia with Endotracheal Intubation: A Prospective, Randomized Controlled Study
Principal Investigator: Wu Jianbo Department: Anesthesiology and Perioperative Medicine
Background \& Objective:
Postoperative hypoxemia is a common respiratory complication in the post-anesthesia care unit (PACU). Conventional pulse oximetry (SpO₂) has a delayed response to hypoventilation, especially during supplemental oxygen therapy. This study aims to investigate whether adding transnasal microstream end-tidal carbon dioxide (EtCO₂) monitoring in the PACU reduces the incidence of hypoxemia in elderly patients after laparoscopic surgery under general anesthesia.
Study Design:
Prospective, randomized, controlled, interventional study.
Participants:
324 elderly patients (age 65-80 years, ASA I-III, BMI 18-30 kg/m²) scheduled for elective laparoscopic surgery under general anesthesia with endotracheal intubation.
Interventions:
Control group (n=162): Routine monitoring with SpO₂ and clinical observation; oxygen delivery at 2 L/min via sampling line without EtCO₂ monitoring.
Experimental group (n=162): Same oxygen delivery plus continuous real-time transnasal microstream EtCO₂ monitoring.
Primary Outcome:
Incidence of postoperative hypoxemia (SpO₂ < 90% for >15 seconds) after extubation in the PACU.
Secondary Outcomes:
Incidence of severe hypoxemia (SpO₂ < 85% for >15 seconds) Lowest SpO₂ during PACU stay Vital signs at predefined time points
PACU length of stay (Steward Recovery Score ≥ 4)
Other adverse events (e.g., nausea, vomiting, agitation, shivering)
Safety Monitoring:
Device-related adverse events (nasal irritation, bleeding), respiratory events (bradypnea, apnea, airway obstruction), and serious adverse events (e.g., need for advanced airway, cardiovascular events) will be recorded and managed according to a stepwise intervention protocol.
Randomization and Blinding:
1:1 randomization using block randomization (SAS 9.4) with allocation concealment (sealed, opaque envelopes). Partial blinding: participants, outcome assessors, and statisticians blinded; anesthesiologists/operators unblinded.
Sample Size Calculation:
Based on pilot data (expected hypoxemia rate: 33% in control vs. 18% in experimental group), α=0.05, power=80%, plus 20% dropout → 162 patients per group (total N=324).
Statistical Analysis:
SPSS 22.0 will be used. Continuous variables (normal distribution) will be compared using t-test; non-normally distributed variables using Mann-Whitney U test. Categorical variables (e.g., hypoxemia incidence) will be compared using chi-square or Fisher's exact test.
Expected Significance:
This study will provide high-level evidence on whether transnasal microstream EtCO₂ monitoring in the PACU can enhance respiratory safety in elderly patients recovering from laparoscopic surgery, potentially reducing hypoxemia and related complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to either the experimental group (transnasal microstream end-tidal carbon dioxide monitoring) or the control group (conventional monitoring with oxygen delivery only, without EtCO₂ monitoring).
| Arm | Type | Receives |
|---|---|---|
| Control Group (Routine Monitoring Group) | Active comparator | Other: Routine MonitoringAfter endotracheal extubation, the sampling end of the sampling line is placed between the patient's mouth and nose, and oxygen is delivered at 2 L/min via the sampling line. The patient receives only routine monitoring (including continuous pulse oximetry and clinical observation) and is not connected to the end-tidal carbon dioxide (EtCO₂) monitoring device. |
| Experimental Group (EtCO₂ Monitoring Group) | Experimental | Device: EtCO₂ MonitoringAfter endotracheal extubation, the sampling end of the sampling line is placed between the patient's mouth and nose, and oxygen is delivered at 2 L/min via the sampling line. At the same time, the sampling line is connected to the monitor to initiate continuous real-time transnasal microstream end-tidal carbon dioxide monitoring. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age 65-80 years;
- ASA physical status I-III;
- BMI 18-30 kg/m²;
- Participants scheduled for elective laparoscopic surgery under general anesthesia with endotracheal intubation;
- Willing to participate in the study and provide written informed consent
Key exclusion criteria (11 listed)
- Patients with nasal bleeding, nasal mucosal injury, nasal cavity occupancy, or other conditions that preclude transnasal carbon dioxide monitoring;
- Patients undergoing emergency surgery;
- Participants requiring postoperative assisted ventilation via endotracheal intubation or tracheostomy;
- Presence of any disease or condition that may cause abnormal end-tidal carbon dioxide waveforms or abnormal baseline pulse oximetry (e.g., congenital heart disease or chronic lung disease);
- Severe cardiac insufficiency (≤4 Metabolic Equivalents [MetS]);
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 |
|---|---|---|
| EtCO₂ MonitoringAfter extubation, the sampling line is placed between the patient's mouth and nose to deliver oxygen at 2 L/min. The sampling line is connected to a patient monitor (RespArrayTM) to initiate continuous real-time transnasal microstream end-tidal carbon dioxide (EtCO₂) monitoring throughout the post-anesthesia care unit (PACU) stay. | Device | Experimental Group (EtCO₂ Monitoring Group) |
| Routine MonitoringAfter extubation, the sampling line is placed between the patient's mouth and nose to deliver oxygen at 2 L/min. The patient receives routine monitoring including continuous pulse oximetry (SpO₂) and clinical observation, but is not connected to the EtCO₂ monitoring device. | Other | Control Group (Routine Monitoring Group) |
Primary outcome
Incidence of post-extubation hypoxemia (SpO₂ < 90% for >15 seconds)
Time frame: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
Closely monitor vital signs, and record the number of episodes of hypoxemia (defined as SpO₂ < 90% lasting for >15 seconds) following tracheal extubation after the patient is transferred from the operating room to the PACU.more than 15 seconds
7 secondary outcomes
Incidence of severe hypoxemia: proportion of patients with SpO₂ < 85% lasting > 15 seconds
Time frame: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
Lowest SpO₂ value during PACU stay Lowest SpO₂ value during PACU stay Lowest SpO₂ value during PACU stay
Time frame: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
PACU length of stay
Time frame: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
Other adverse events
Time frame: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
Record the changes in heart rate following the patient's admission to the PACU
Time frame: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
Record the patient's blood pressure after admission to the PACU
Time frame: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
Record the changes in the patient's SpO₂ values after admission to the PACU
Time frame: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
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 17 Jun 2026.
- 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.
Jianbo WU, Doctoral principal investigator
Shandong First Medical University
Questions about this trial
What is this clinical trial studying?
A study testing EtCO₂ Monitoring and Routine Monitoring in people with Elderly Patients and Laparoscopic Surgery, run by Jianbo Wu.
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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Jianbo WU (18560083793, jianbowu@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-extubation hypoxemia (SpO₂ < 90% for >15 seconds) (time frame: During the period in the post-anesthesia care unit (PACU) (up to 1 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.