Transnasal Microstream EtCO2 Reduces Hypoxemia During Emergence in Aged Post-Abdomen Surgery (NCT07652385) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Transnasal Microstream EtCO2 Reduces Hypoxemia During Emergence in Aged Post-Abdomen Surgery
324 participantsStarted 2026-07-01
Plain-language 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 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).
Who can participate
Age range
65 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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);
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focuses specifically on elderly patients recovering from laparoscopic abdominal surgery — given my age and the type of surgery I'm having, does my doctor think I would fit the profile of patients this study is looking at?
2The trial is testing whether using a special breathing monitor through the nose (called transnasal microstream capnography) during wake-up from anesthesia can reduce dangerous drops in oxygen levels — is this monitoring approach something my care team already uses, or would participating in this study be the only way I'd have access to it?
3Since this trial isn't recruiting yet, how might that affect my options if I'm interested — is there a standard monitoring approach my anesthesia team would use in the meantime to watch for low oxygen levels after my breathing tube is removed?
4The study is measuring whether oxygen levels drop below 90% for more than 15 seconds after extubation — how common is that kind of oxygen drop in patients like me after laparoscopic abdominal surgery, and what are the real-world risks if it happens?
5Because this study is listed as Phase NA, meaning it's evaluating a monitoring tool rather than a new drug or procedure, can my doctor explain what the main unknowns still are and whether there are any patient safety considerations I should think through before deciding whether to discuss enrollment when the trial opens?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of post-extubation hypoxemia (SpO₂ < 90% for >15 seconds)
Timeframe: During the period in the post-anesthesia care unit (PACU) (up to 1 days)