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

16 juin 2026 mis à jour par: Jianbo Wu

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).

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

324

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Control Group (Routine Monitoring Group)
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.
Autre: 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.
Expérimental: Experimental Group (EtCO₂ Monitoring Group)
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.
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of post-extubation hypoxemia (SpO₂ < 90% for >15 seconds)
Délai: 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
During the period in the post-anesthesia care unit (PACU) (up to 1 days)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Incidence of severe hypoxemia: proportion of patients with SpO₂ < 85% lasting > 15 seconds
Délai: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
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
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
Délai: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
Observe and record the lowest SpO₂ value during the patient's stay in the PACU
During the period in the post-anesthesia care unit (PACU) (up to 1 days)
PACU length of stay
Délai: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
time from entering the PACU until achieving a Steward recovery score >4, meeting the criteria for discharge
During the period in the post-anesthesia care unit (PACU) (up to 1 days)
Other adverse events
Délai: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
Record adverse events occurring during the entire PACU stay
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
Délai: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
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)
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
Délai: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
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)
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
Délai: During the period in the post-anesthesia care unit (PACU) (up to 1 days)
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)
During the period in the post-anesthesia care unit (PACU) (up to 1 days)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Jianbo Wu

Les enquêteurs

  • Chercheur principal: Jianbo WU, Doctoral, Shandong First Medical University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

1 juillet 2028

Achèvement de l'étude (Estimé)

1 octobre 2028

Dates d'inscription aux études

Première soumission

5 juin 2026

Première soumission répondant aux critères de contrôle qualité

16 juin 2026

Première publication (Réel)

17 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • YXLL-KY-2026(147)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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