Transnasal Microstream EtCO2 Reduces Hypoxemia During Emergence in Aged Post-Abdomen Surgery
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
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jianbo WU
- Número de teléfono: 18560083793
- Correo electrónico: jianbowu@sdu.edu.cn
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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.
|
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of post-extubation hypoxemia (SpO₂ < 90% for >15 seconds)
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of severe hypoxemia: proportion of patients with SpO₂ < 85% lasting > 15 seconds
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jianbo WU, Doctoral, Shandong First Medical University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- YXLL-KY-2026(147)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Routine Monitoring
-
The Hong Kong Polytechnic UniversityTerminadoDispositivo ineficazHong Kong
-
Philips Clinical & Medical Affairs GlobalReclutamientoQuirúrgico No Cardiaco | Unidad de Cuidados Intensivos (UCI)Estados Unidos, Alemania
-
Singapore General HospitalKK Women's and Children's Hospital; SingHealth PolyclinicsTerminado
-
Kaohsiung Medical University Chung-Ho Memorial...Reclutamiento
-
Royal Brompton & Harefield NHS Foundation TrustUniversity of Oxford; National Institute for Health Research, United KingdomTerminadoApnea del Sueño Obstructiva | Apnea posicional del sueñoReino Unido
-
Michal Roll PhD,MBADesconocido
-
Dartmouth-Hitchcock Medical CenterRetirado
-
University of AarhusOdense University Hospital; Aarhus University Hospital; Protac A/S; Innovation Fund...ReclutamientoInsomnio debido a un trastorno mentalDinamarca
-
Melissa Voigt HansenTerminadoCáncer de mama | Ansiedad | Trastornos del ritmo circadianoDinamarca