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Transnasal Microstream EtCO2 Reduces Hypoxemia During Emergence in Aged Post-Abdomen Surgery

NCT07652385 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2026-06-17

No results posted yet for this study

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).

Conditions

  • Elderly Patients
  • Laparoscopic Surgery
  • Postoperative Hypoxemia
  • Capnography

Interventions

DEVICE

EtCO₂ Monitoring

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.

OTHER

Routine Monitoring

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.

Sponsors & Collaborators

  • Jianbo Wu

    lead OTHER

Principal Investigators

  • Jianbo WU, Doctoral · Shandong First Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-07-01
Completion
2028-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07652385 on ClinicalTrials.gov