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Master Thesis

Apnoeic oxygenation during airway management in infants for elective endotracheal intubation (OXYNEO Trial): A protocol for a randomized double-blind controlled trial

Abstract : 1. Introduction Hypoxemia is the leading cause of morbidity and mortality in paediatric anaesthesia. It can be major during induction for general anaesthesia at the time of intubation especially in case of difficult access to the airways or repeated attempts. Preoxygenation has been used to maximize oxygen reserves in patients and to prolong the safe apnoeic time during laryngoscopy and intubation phases. Nevertheless, safe apnoea duration remains less than 2 minutes for infants. Apnoeic oxygenation by high flow oxygen delivery from nasal cannula has already shown its effectiveness by increasing apnoea duration in adult patients in intensive care units or in operating room for patients at risk of difficult intubation (bariatric population) and in children. We designed a clinical trial to test the hypothesis that apnoeic oxygenation reduces the incidence and severity of hypoxemia and also decrease adverse events during intubation in infants compared with standard care. 2. Methods and analysis The OXYNEO trial is a monocenter randomized controlled trial performed in paediatric center in the University Hospital of Clermont-Ferrand, France. 72 infants aged under 24 months requiring intubation for scheduled surgery will be enrolled and allocated to High Flow oxygenation (HF), Low Flow oxygenation (LF) or standard care (SC) in a 1:1:1 allocation with stratification by age (0-6, 6-12 and 12-24 months). Infants allocated to High Flow apnoeic oxygenation receive 1L/Kg bodyweight transnasal oxygen, infants allocated to Low Flow apnoeic oxygenation receive 0,2L/Kg bodyweight transnasal oxygen whereas children in the control arm will not receive any transnasal oxygen 15 insufflation during apnoea. The primary outcomes is defined as the time in seconds between the onset of apnoea and : 1) Airway management complete or 2) desaturation (SpO2<95%) Analyses will be conducted on an intention-to-treat basis. 3. Strengths and limitations of this study • This is the first study investigating the use of apnoeic oxygenation by High Flow nasal cannula during infants airway management in current practice and its effects on hypoxemia’s frequency and gravity. • High Flow oxygenation will be compared at Low Flow oxygenation, as recent study suggest Low Flow is not inferior. • Apart from the application of apnoeic oxygenation, all other aspects of the intubation process are standardized according to the actual standard of care, ensuring that bias and confounding are minimized and any observed effect can be more reliably attributed to the intervention applied. • Because knowing apnoea time duration to secure the airway is an important factor of bias for the airway management rapidity, we develop a standardized double-blinded protocol that not allow anaesthesia team to know the apnoeic oxygenation group allowed. It is the first randomized double-blinded study in this population. • In this study, apnoeic oxygenation by High Flow nasal cannula is only evaluated for infants because this population has the most important risk of hypoxemia and respiratory adverse events due to anatomical and physiological particularity (lower apnoea duration).
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https://dumas.ccsd.cnrs.fr/dumas-02441038
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Thomas Costilles. Apnoeic oxygenation during airway management in infants for elective endotracheal intubation (OXYNEO Trial): A protocol for a randomized double-blind controlled trial. Life Sciences [q-bio]. 2019. ⟨dumas-02441038⟩

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