← Back to all trials
Not Yet Recruiting
NCT07652385
Transnasal Microstream EtCO2 Reduces Hypoxemia During Emergence in Aged Post-Abdomen Surgery
Conditions: Elderly Patients, Laparoscopic Surgery, Postoperative Hypoxemia, Capnography
Sex: All
Ages: 65 Years – 80 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 324
Sponsor: Jianbo Wu
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).
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07652385). StuddyBuddy aggregates publicly available trial information.