A Prospective Clinical Study Observed the Effects of Tubeless Anesthesia Method That Preserves Spontaneous Breathing and the Double-lumen Bronchial Intubation on the Brain Health During the Perioperative Period
19 de julio de 2026 actualizado por: Fengfa Yang, Guangzhou Medical University
Tubeless Anesthesia With Preserved Spontaneous Breathing and the Construction of a Perioperative Brain Health Safety System for Thoracic Surgery Patients Study 2: A Prospective Clinical Study Observing the Impact of Two Anesthesia Techniques-Tubeless With Preserved Spontaneous Breathing Versus Double-Lumen Endotracheal Intubation-on Perioperative Brain Health
This project conducts a prospective cohort study.
By using multiple questionnaire survey methods such as the Pittsburgh Sleep Quality Index (PSQI) electronic wristband, QOR15, Pain Catastrophizing Scale (PCS), European Five-Dimensional Health Scale (EQ-5D), Revised American Pain Society Patient Follow-up Questionnaire (APS-POQ-R), Mini-Mental State Examination (MMSE), as well as perioperative stress and related indicators, hypothalamic-pituitary-adrenal axis (HPA) endocrine indicators, sublingual microcirculation, electroencephalogram, etc., comprehensive assessment is made of the correlations between the two different anesthesia methods of Tubeless retention of spontaneous breathing and double-lumen bronchial intubation and postoperative sleep, chronic pain and cognitive function, to construct a perioperative brain health safety system to improve prognosis; at the same time, optimize the perioperative sedation and analgesia plan and promote the postoperative brain health recovery of patients.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
De observación
Inscripción (Estimado)
400
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Lan Lan, PHD
- Número de teléfono: +8602083062566
- Correo electrónico: lanlan@gzhmu.edu.cn
Copia de seguridad de contactos de estudio
- Nombre: Fengfa Yang, BS
- Número de teléfono: +8602083062566
- Correo electrónico: yff18312377134@163.com
Ubicaciones de estudio
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510120
- The First Affiliated Hospital of Guangzhou Medical University
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Contacto:
- Lan Lan, PHD
- Número de teléfono: +8602083062566
- Correo electrónico: lanlan@gzhmu.edu.cn
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Patients who underwent elective non-anatomic partial lung resection surgery at the First Affiliated Hospital of Guangzhou Medical University
Descripción
Inclusion Criteria:
- Patient age: 18 - 75 years old
- Patients meeting the standards of the American Society of Anesthesiologists (ASA) I-III grade and the New York Heart Association (NYHA) I-II class
- Body Mass Index (BMI) < 30 kg/m2
- Intraoperative blood loss less than 300 ml
- No severe cardiac or pulmonary dysfunction [first-second forced vital capacity (FEV1%) predicted value] > 50%, ejection fraction (EF) > 50%
- No contraindications related to paravertebral nerve block and intercostal nerve block
- Able to sign the informed consent form and possess communication, reading and writing abilities
- Postoperative hospital stay of at least one day
- No preoperative sleep disorders, no cognitive dysfunction (PSQI ≤ 10 points, PCS ≤ 38 points, MMSE > 27 points)
Exclusion Criteria:
- Already diagnosed with a mental disorder or had a preoperative Mini-Mental State Examination (MMSE) score of less than 27
- History of opioid abuse
- Patients who were admitted to the ICU after surgery
- Have severe cardiovascular, respiratory diseases
- Experienced critical rescue during or after the surgery
- Complicated with coagulation dysfunction, severe hypoxia or hypercapnia, or liver and kidney dysfunction
- Difficult airway management
- Changed anesthetic agent or surgical plan
- Severe lacunar cerebral infarction, ischemic stroke or other neurological diseases
- Changed anesthetic agent or surgical plan during the surgery;
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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tubeless group
Patients undergoing elective non-anatomic partial lung resection surgery using the Tubeless technique for maintaining spontaneous breathing anesthesia
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double-lumen bronchial intubation group
Patients undergoing elective non-anatomic lung segmentectomy surgery using the double-lumen bronchial tube anesthesia method
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Concentration of cognitive function biomarkers in the serum samples of 400 patients
Periodo de tiempo: Before the start of the surgery (T1), at the end of the surgery (T2), and on the first day after the surgery (T3)
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At time points T1, T2, and T3, 5 ml of peripheral venous blood was collected to test the biological indicators of postoperative cognitive function.
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Before the start of the surgery (T1), at the end of the surgery (T2), and on the first day after the surgery (T3)
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Concentrations of HPA axis-related indicators in the serum samples of 400 patients
Periodo de tiempo: Before the start of the surgery (T1), at the end of the surgery (T2)
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At the TI-T2 time point, 5 ml of peripheral venous blood was collected for the detection of HPA axis-related indicators.
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Before the start of the surgery (T1), at the end of the surgery (T2)
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The concentrations of laboratory test indicators in the serum samples of 400 patients
Periodo de tiempo: Before the start of the surgery (T1), and on the first day after the surgery (T3)
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Record the laboratory test indicators at time points T1 and T3
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Before the start of the surgery (T1), and on the first day after the surgery (T3)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Anesthesia Record Form
Periodo de tiempo: at the end of the surgery (T2)
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Record the vital signs at the T2 time point
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at the end of the surgery (T2)
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Case information system collection
Periodo de tiempo: Before the start of the surgery (T1), and on the first day after the surgery (T3)
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Record the pulmonary function, chest X-ray or chest CT at time points T1 and T3
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Before the start of the surgery (T1), and on the first day after the surgery (T3)
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Anesthesia Record Form
Periodo de tiempo: During the operation
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Record the intraoperative conditions
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During the operation
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Postoperative follow-up records
Periodo de tiempo: through study completion, an average of 1 year
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Record the time of chest tube removal after surgery
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through study completion, an average of 1 year
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Postoperative follow-up records
Periodo de tiempo: through study completion, an average of 1 year
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the usage of postoperative analgesic drugs
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through study completion, an average of 1 year
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Postoperative follow-up records
Periodo de tiempo: through study completion, an average of 1 year
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the postoperative hospital stay
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through study completion, an average of 1 year
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Postoperative follow-up records
Periodo de tiempo: through study completion, an average of 1 year
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the total hospitalization cost
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through study completion, an average of 1 year
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postoperative follow-up records
Periodo de tiempo: through study completion, an average of 1 year
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Record the occurrence of adverse events during the perioperative period
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through study completion, an average of 1 year
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Lan Lan, PHD, The First Affiliated Hospital of Guangzhou Medical University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
20 de julio de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
13 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
19 de julio de 2026
Publicado por primera vez (Actual)
22 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
19 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- ES-2025-216-02
- GMUCR2025-02011 (Otro número de subvención/financiamiento: Guangzhou Medical University)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Patient clinical data
Criterios de acceso compartido de IPD
The data can be obtained by email from Lan Lan (Email: lanlan@gzhmu.edu.cn) for clinical requirements.
Tipo de información de apoyo para compartir IPD
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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