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. 2020 Apr 19;21(1):341.
doi: 10.1186/s13063-020-4218-2.

Effectiveness of steroids versus placebo in preventing upper airway obstruction after extubation in critically ill children: rationale and design of a multicentric, double-blind, randomized study

Gema Manrique  1   2   3   4 , Laura Butragueño-Laiseca  1   2   3 , Rafael González  1   2   3 , Corsino Rey  5 , Zuriñe Martínez de Compañon  6 , Javier Gil  7 , Antonio Rodríguez-Núñez  8 , Cecilia Martínez  2   3   9 , Silvia Manrique  2   3   9 , Jesús López-Herce  10   11   12   13
Affiliations

Effectiveness of steroids versus placebo in preventing upper airway obstruction after extubation in critically ill children: rationale and design of a multicentric, double-blind, randomized study

Gema Manrique et al. Trials. .

Abstract

Background: Post-extubation upper airway obstruction (UAO) is a frequent complication causing stridor and respiratory distress, which occasionally 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 who are between 1 month and 16 years of age and who have been intubated for more than 48 h. Patients who have airway disorders or who have received steroids within the previous seven days will be excluded. Patients will be randomly assigned to receive either placebo or a therapy with dexamethasone 0.25 mg/kg every 6 h to be started 6 to 12 h 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 access the reduction in the incidence of moderate to severe UAO symptoms following extubation. Secondary objectives include assessing the decrease in the incidence of reintubation, evaluating the use of additional therapies for UAO, and monitoring potential side effects of dexamethasone.

Discussion: The results of this study will contribute to the existing evidence on prophylaxis for post-extubation airway obstruction.

Trial registration: EudraCT identifier: 2009-016596-30. Registered on May 11, 2010.

Keywords: Children; Dexamethasone; Extubation; Steroids; Stridor; Upper airway obstruction.

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Conflict of interest statement

The authors declare that they have no competing interests. Neither participants nor investigators will receive any compensation for participating in this study.

Figures

Fig. 1
Fig. 1
CONSORT (Consolidated Standards of Reporting Trials) flow diagram
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