High Fresh Gas Flow After Intubation
High Fresh Gas Flow After Intubation - A Randomized Clinical Trial
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Västmanland
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Köping, Västmanland, Suède, 731 30
- Landstinget Västmanland
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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. |
|
Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Atelectasis
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Arterial blood gases
Délai: Within 2-3 hours perioperatively
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Within 2-3 hours perioperatively
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Mats Enlund, MD, PhD, Landstinget i Värmland
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Dnr 2012/335
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