High Fresh Gas Flow After Intubation
High Fresh Gas Flow After Intubation - A Randomized Clinical Trial
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Västmanland
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Köping, Västmanland, Suecia, 731 30
- Landstinget Västmanland
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Healthy patients, American Society of Anesthesiology (ASA) I-II
- Patients scheduled for orthopaedic day case surgery in general anaesthesia
Exclusion Criteria:
- ASA class III or higher
- Body Mass Index (BMI) 30 or higher
- Arterial oxygen saturation (SpO2) <94% breathing air
- Chronic Obstructive Pulmonary Disease (COPD)
- Ischemic heart disease
- Haemoglobin <100g/L
- Known or anticipated difficult airway and/or intubation
- Active smokers and ex-smokers with a history of more than 6 pack years
- Need for interscalene or supraclavicular regional anaesthesia with risk of phrenic nerve paralysis
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Control group, conventional ventilatory settings
Handling of the airway during induction and intubation is performed in a conventional manner. Initial ventilatory settings are also done in a conventional manner. |
Handling of the airway during induction and intubation is performed in a conventional manner. Initial ventilatory settings are also done in a conventional manner. As soon as correct position of the endotracheal tube is confirmed, controlled ventilation is started with a tidal volume of 7 mL/kg ideal body weight, PEEP 6 or 8 cm H2O (8 if BMI >25) and a respiratory frequency of 10. The fresh gas flow is set to 1 Liter per minute with an oxygen mixture of 40%, aiming for an inspired FiO2 of 30-35%. Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure. |
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Comparador activo: High fresh gas flow, high minute ventilation
Handling of the airway during induction and intubation is performed in a conventional manner. Immediately after confirming a successful intubation the effect of preoxygenation is eliminated with an anti-preoxygenation maneuver. |
Handling of the airway during induction and intubation is performed in a conventional manner. Immediately after confirming a successful intubation, the effect of preoxygenation is eliminated with a fresh gas flow of 10 L/min of air, delivered with volume controlled ventilation consisting of tidal volumes of approximately 15 ml/kg ideal body weight, a positive expiratory pressure of 10 cm H20 and a respiratory frequency of 10. As soon as the end tidal O2 reaches 25%, the ventilator settings are adjusted to normal values (same as in the control group), i.e. tidal volume 7 mL/kg ideal body weight, PEEP 6 or 8 cm H2O (8 if BMI >25). The mixture of oxygen in the fresh gas is increased to 40% and the fresh gas flow is set to 1 Liter per minute, aiming for an inspired FiO2 of 30-35%. Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Atelectasis
Periodo de tiempo: Within 1-2 hours, just before emergence from anesthesia
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The area of atelectasis in the lungs is assessed by computed tomography (CT) 10 mm above the dome of the right diaphragm and expressed in cm2 and as % of the total lung area in the particular scan.
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Within 1-2 hours, just before emergence from anesthesia
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Arterial blood gases
Periodo de tiempo: Within 2-3 hours perioperatively
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Within 2-3 hours perioperatively
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Mats Enlund, MD, PhD, Landstinget i Värmland
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
Otros números de identificación del estudio
- Dnr 2012/335
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