Background Post-extubation upper airway obstruction (UAO) is a frequent complication causing stridor and respiratory distress, which occasionally may require reintubation, thereby increasing morbidity and mortality rates. Contradictory results have been obtained in studies assessing the effectiveness of steroids in preventing post-extubation UAO, and the available evidence is limited. We designed a multicentric randomized, placebo-controlled study to explore the effectiveness of dexamethasone in preventing post-extubation UAO in children. Methods A multicentric, prospective, double-blind, randomized, placebo-controlled, phase IV clinical trial has been designed. The sample will include pediatric patients between 1 month and 16 years of age who have been intubated for more than 48 hours. Patients with airway disorders or who have received steroids within the last seven days will be excluded. Patients will be randomized to receive either placebo or a therapy with dexamethasone 0.25 mg/kg every 6 hours to be started 6-to-12 hours prior to extubation, to a total of four doses.Randomization will be performed at a 1:1 ratio. Follow-up of patients will be carried out for 48 h after extubation. The main objective of this study is to assess the reduction of UAO symptoms following extubation, as measured using the Taussig scale. Secondary objectives include assessing the decrease in the incidence of reintubation, evaluating the use of additional therapies for upper airway obstruction, and monitoring dexamethasone potential side effects. Discussion The results of this study will contribute to the existing evidence on prophylaxis for post-extubation airway obstruction.
BackgroundCritically-ill pediatric patients frequently require endotracheal intubation. Post-extubation upper airway obstruction (UAO) is a common complication that affects up to a third of patients who requireLaryngeal edema is more frequent and severe in children than in adults due to the small diameter of their airways. Indeed, this type of edema in children affects the subglottal region more frequently than the glottal region [2,4]. Signs of airway obstruction include stridor and respiratory distress, which require reintubation in 6-13% of patients [1][2][3].Risk factors related to post-extubation UAO include underlying respiratory or neurological disease, This study was supported by Carlos III Health Institute (Sub-Directorate General for Research Assessment and Promotion and the European Regional Development Fund) as a non-commercial clinical trial (grant number EC11-077).The study medication and placebo were provided by Kern-Pharma in their primary packaging as ampoules.The investigators, patients or their families will not receive any compensation for their participation in this study.
Authors' contributionsJLH conceived the study, participated in the study design and revised the manuscript.RGC participated in the study design, revised the manuscript and is responsible for data collection.GM and LBL drafted the manuscript and are responsible for data c...