- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03395782
Factors Determining Oxygen Wash in During Pre-oxygenation
Factors Determining End-tidal O2 Concentration in During Pre-oxygenation
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Before induction of general anaesthesia pre-oxygenation is a recommended procedure to enhance the time available for solving a problem with the airway or intubation during induction. This can be accomplished by letting the patient breath normal tidal volumes with 100% oxygen for 3 to 5 minutes during pre-oxygenation. If there is airway closure during tidal volume breathing, pre-oxygenation needs longer time to achieve a maximum effect. Airway closure increases with advanced age and a few earlier studies has also shown a correlation between older age and longer time for the rise in the end-tidal O2 concentration during pre-oxygenation.
Pre-oxygenation is a strongly recommended safety procedure before starting anaesthesia but has at least one major side affect: it is the main reason for the development of atelectasis in the lungs during anaesthesia. Atelectasis impairs oxygenation during anaesthesia and probably increase the risk for postoperative pulmonary complications.
Postoperative complications are more common with advanced age and it is important to understand the mechanisms and risk factors involved.
In this study, the investigators hypothesise that the PaO2 as measured before the start of pre-oxygenation, with the patient breathing air, is a better predictor than age for estimating the time necessary for achieving the goal of pre-oxygenation. If this assumption is correct it might have implication for how pre-oxygenation should be adjusted with advancing age.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Västmanland
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Köping, Västmanland, Suecia, 73130
- Köping County Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients scheduled for general anaesthesia in American Society of Anesthesiology (ASA) physical status classification grade I-III.
- Body mass index over 18.5 and less than 30 kg/m2
- Peripheral oxygen saturation 92% or more on air.
Exclusion Criteria:
- ASA IV.
- Patients with active smoking and former smokers with a history of smoking more than 6 pack-years.
- Chronic obstructive lung disease.
- Bloodgas with PaO2 ≤ 8 kilopascal (kPa) or PaCO2 ≥ 6.5 kPa.
- Continuous positive airway pressure treatment at night.
- Heart failure or angina pectoris.
- Hemoglobin value less than 100 g/L.
- Pregnancy.
- Any neuromuscular or neurologic illness reducing ventilatory capacity.
- Any endocrine disease influencing basic metabolic demand.
- Not possible to achieve a tight mask seal.
- Patient unable to follow instructions.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
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Age group 40-49
30 patients will be stratified to this age group.
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Age group 50-59
30 patients will be stratified to this age group.
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Age group 60-69
30 patients will be stratified to this age group.
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Age group 70-79
30 patients will be stratified to this age group.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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PaO2 breathing air before start of pre-oxygenation and the rise in end-tidal O2 during pre-oxygenation.
Periodo de tiempo: 5 minutes.
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An arterial bloodgas with the patient in the supine position breathing air will be analysed with regards to PaO2 and correlated to the rise in end-tidal O2 concentration during pre-oxygenation.
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5 minutes.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Age and the rise in end-tidal O2 during pre-oxygenation.
Periodo de tiempo: 5 minutes.
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Age will be correlated to the rise in end-tidal O2 during pre-oxygenation.
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5 minutes.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lennart Edmark, Ph.D., Region Västmanland
Publicaciones y enlaces útiles
Publicaciones Generales
- Kang H, Park HJ, Baek SK, Choi J, Park SJ. Effects of preoxygenation with the three minutes tidal volume breathing technique in the elderly. Korean J Anesthesiol. 2010 Apr;58(4):369-73. doi: 10.4097/kjae.2010.58.4.369. Epub 2010 Apr 28.
- Sum Ping SJ, Makary LF, Van Hal MD. Factors influencing oxygen store during denitrogenation in the healthy patient. J Clin Anesth. 2009 May;21(3):183-9. doi: 10.1016/j.jclinane.2008.07.004.
- Milic-Emili J, Torchio R, D'Angelo E. Closing volume: a reappraisal (1967-2007). Eur J Appl Physiol. 2007 Apr;99(6):567-83. doi: 10.1007/s00421-006-0389-0. Epub 2007 Jan 20.
- Gambee AM, Hertzka RE, Fisher DM. Preoxygenation techniques: comparison of three minutes and four breaths. Anesth Analg. 1987 May;66(5):468-70. No abstract available.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- 20170517-184
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.
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