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- Ensayo clínico NCT07752173
Comparison of Acute Airway/Respiratory Complications and Intervention Requirements in Extubations Performed During On-Hours Versus Off-Hours
Comparison of Acute Airway/Respiratory Complications and Intervention Requirements in Extubations Performed During On-Hours Versus Off-Hours: A Prospective Observational Cohort Study
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mehmet Yilmaz, Md
- Número de teléfono: 05052174432
- Correo electrónico: drmyilmaz33@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Ali Mete Temel, Md
- Número de teléfono: +905438465215
- Correo electrónico: metetemel60@hotmail.com
Ubicaciones de estudio
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Izmıt
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Kocaeli, Izmıt, Turquía (Türkiye), 41001
- Reclutamiento
- Kocaeli City Hospital
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Contacto:
- Mehmet Yilmaz, Md
- Número de teléfono: 05052174432
- Correo electrónico: drmyilmaz33@gmail.com
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Sub-Investigador:
- Mehmet Yilmaz, Md
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Contacto:
- Ali Mete Temel, Md
- Número de teléfono: +905438465215
- Correo electrónico: metetemel60@hotmail.com
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Investigador principal:
- Ali Mete Temel, Md
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age ≥ 18 years
Undergoing elective or emergency surgery under general anaesthesia with endotracheal intubation
Planned tracheal extubation in the operating theatre or post-anaesthesia care unit (PACU)
Provision of written informed consent (or deferred consent for emergency cases, in accordance with national regulations)
Exclusion Criteria:
- Patients undergoing surgery under regional anaesthesia or sedation without endotracheal intubation
Patients with a tracheostomy in situ
Patients who remain intubated and are transferred to the intensive care unit (ICU) postoperatively
Patients undergoing cardiothoracic surgery involving cardiopulmonary bypass
Emergency airway management performed outside the operating theatre (e.g., ICU, emergency department)
Patients with known or suspected difficult airway requiring awake fibreoptic intubation
Patients who refuse to provide informed consent or withdraw consent during the study
Pregnant patients
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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On-Hours
On-hours group: Extubations performed between 08:00 and 16:00 on weekdays (Monday to Friday), excluding public holidays.
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An extubation attempt is the planned, deliberate removal of the endotracheal tube from the patient's trachea, beginning with preparatory manoeuvres (such as oropharyngeal suctioning and cuff deflation) and ending with the complete withdrawal of the tube and establishment of a patent native airway with adequate spontaneous breathing.
Description: The Karolinska Sleepiness Scale (KSS), a validated 9-point Likert scale (1 = extremely alert, 9 = very sleepy, fighting sleep), will be administered to the attending anaesthetist responsible for performing the extubation immediately prior to the extubation procedure.
This assessment is performed to objectively quantify the clinician's subjective level of sleepiness and fatigue at the time of extubation.
The KSS score will be recorded as a predictor/exposure variable to evaluate the association between anaesthetist fatigue and the occurrence of acute airway and respiratory complications during extubation.
This assessment is applied uniformly across both study groups (on-hours and off-hours extubations).
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Off-Hours
Off-hours group: Extubations performed after 16:00 on weekdays, as well as all extubations performed on weekends and public holidays, regardless of the time of day
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An extubation attempt is the planned, deliberate removal of the endotracheal tube from the patient's trachea, beginning with preparatory manoeuvres (such as oropharyngeal suctioning and cuff deflation) and ending with the complete withdrawal of the tube and establishment of a patent native airway with adequate spontaneous breathing.
Description: The Karolinska Sleepiness Scale (KSS), a validated 9-point Likert scale (1 = extremely alert, 9 = very sleepy, fighting sleep), will be administered to the attending anaesthetist responsible for performing the extubation immediately prior to the extubation procedure.
This assessment is performed to objectively quantify the clinician's subjective level of sleepiness and fatigue at the time of extubation.
The KSS score will be recorded as a predictor/exposure variable to evaluate the association between anaesthetist fatigue and the occurrence of acute airway and respiratory complications during extubation.
This assessment is applied uniformly across both study groups (on-hours and off-hours extubations).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Desaturation During Extubation
Periodo de tiempo: 30 min. after extubation
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Description: The occurrence of desaturation during the extubation procedure itself, defined as a peripheral oxygen saturation (SpO₂) < 90% lasting for ≥ 30 seconds (or a ≥ 5% decrease from baseline in patients with pre-existing hypoxaemia), measured from the initiation of extubation manoeuvres (cuff deflation and suctioning) until the complete withdrawal of the endotracheal tube. Time Frame: Desaturation occurring during the extubation attempt and within the first 30 minutes post-extubation. |
30 min. after extubation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Other acute airway/respiratory complications
Periodo de tiempo: 30 min. after extubation
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(laryngospasm, airway obstruction, bronchospasm, aspiration, apnoea, haemodynamic instability, arrhythmias, unplanned reintubation, surgical airway).
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30 min. after extubation
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intervention requirement by type
Periodo de tiempo: 30 min. after extubation
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(simple airway manoeuvres, bag-mask ventilation, pharmacological agents, reintubation, surgical airway)
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30 min. after extubation
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Mehmet Yilmaz, Kocaeli City Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Xie Q, Shen Z, Pan M, Li Y, Luo Z, Wang C, Zhao L, Fang Y, Ding X, Teng J, Xu J. Weekend effect on the incidence and outcomes of cardiac surgery associated - acute kidney injury. BMC Cardiovasc Disord. 2023 Oct 27;23(1):524. doi: 10.1186/s12872-023-03431-4.
- Patel MS, Thomas JJ, Aguayo X, Gutmann D, Sarwary SH, Wain M. The Effect of Weekend Surgery on Outcomes of Emergency Laparotomy: Experience at a High Volume District General Hospital. Cureus. 2022 Mar 27;14(3):e23537. doi: 10.7759/cureus.23537. eCollection 2022 Mar.
- Ash-Rafzadeh H, Chambers TJ, Velez FO, Moodie CC, Garrett JR, Fontaine JP, Toloza EM. Effect of Surgical Day of Week on Postoperative Outcomes After Robotic-Assisted Pulmonary Lobectomy. Cureus. 2023 Feb 23;15(2):e35379. doi: 10.7759/cureus.35379. eCollection 2023 Feb.
- Maman D, Steinfeld Y, Berkovich Y. No Weekend Effect in Elective Primary Total Knee Arthroplasty: A Nationwide Analysis of 437,121 U.S. Cases. J Clin Med. 2025 Dec 12;14(24):8816. doi: 10.3390/jcm14248816.
- Cortegiani A, Gregoretti C, Neto AS, Hemmes SNT, Ball L, Canet J, Hiesmayr M, Hollmann MW, Mills GH, Melo MFV, Putensen C, Schmid W, Severgnini P, Wrigge H, Gama de Abreu M, Schultz MJ, Pelosi P; LAS VEGAS Investigators, the PROVE Network, and the Clinical Trial Network of the European Society of Anaesthesiology. Association between night-time surgery and occurrence of intraoperative adverse events and postoperative pulmonary complications. Br J Anaesth. 2019 Mar;122(3):361-369. doi: 10.1016/j.bja.2018.10.063. Epub 2019 Feb 8.
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
Palabras clave
Términos MeSH relevantes adicionales
- Calidad, acceso y evaluación de la atención médica
- Técnicas de investigación
- Métodos epidemiológicos
- Terapéutica
- Recopilación de datos
- Mecanismos de evaluación de atención médica
- Calidad de la atención médica
- Salud pública
- Medio ambiente y salud pública
- Gestión de las vías respiratorias
- Encuestas y cuestionarios
- Extubación de la vía aérea
Otros números de identificación del estudio
- KSH-2026-89
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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