Transnasal Microstream EtCO2 Reduces Hypoxemia During Emergence in Aged Post-Abdomen Surgery
Starting soon · Not applicable
Conditions studied: Elderly Patients, Laparoscopic Surgery, Postoperative Hypoxemia, Capnography
In brief
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).
Key facts
- Study ID
- NCT07652385
- Run by
- Jianbo Wu
- People needed
- 324
- Starts
- 2026-07-01
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2026-06-17
Who can join
Age: 65 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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