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

16. Juni 2026 aktualisiert von: 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).

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

324

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Sonstiges: 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.
Experimental: 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.
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of post-extubation hypoxemia (SpO₂ < 90% for >15 seconds)
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of severe hypoxemia: proportion of patients with SpO₂ < 85% lasting > 15 seconds
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Jianbo Wu

Ermittler

  • Hauptermittler: Jianbo WU, Doctoral, Shandong First Medical University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. Juli 2028

Studienabschluss (Geschätzt)

1. Oktober 2028

Studienanmeldedaten

Zuerst eingereicht

5. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. Juni 2026

Zuerst gepostet (Tatsächlich)

17. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • YXLL-KY-2026(147)

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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