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

16. června 2026 aktualizováno: 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).

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

324

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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.
Jiný: 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.
Experimentální: 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.
Přístroj: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Incidence of post-extubation hypoxemia (SpO₂ < 90% for >15 seconds)
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Incidence of severe hypoxemia: proportion of patients with SpO₂ < 85% lasting > 15 seconds
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Jianbo Wu

Vyšetřovatelé

  • Vrchní vyšetřovatel: Jianbo WU, Doctoral, Shandong First Medical University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

1. července 2028

Dokončení studie (Odhadovaný)

1. října 2028

Termíny zápisu do studia

První předloženo

5. června 2026

První předloženo, které splnilo kritéria kontroly kvality

16. června 2026

První zveřejněno (Aktuální)

17. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • YXLL-KY-2026(147)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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