Multicenter randomized clinical trial comparing dexamethasone versus placebo in preventing upper airway obstruction after extubation in critically ill children

Abstract

To analyze the effectiveness of dexamethasone in preventing upper airway obstruction (UAO) symptoms after extubation and the need of reintubation in critically ill children. Multicenter, prospective, double-blind, randomized, phase IV clinical trial involving five pediatric intensive care units. Children between 1 month and 16 years-of-age intubated for more than 48 h were included. Patients were randomized to receive placebo or dexamethasone 0.25 mg/kg every 6 h, 6-to-12 h prior to extubation (four doses). 48 h follow-up was carried out after extubation. Severity of UAO symptoms (Taussig score, stridor) and reintubation requirement were compared. 147 patients were randomized (10 were excluded), 70 patients received dexamethasone and 67 placebo. No global differences were found in the presence of stridor or moderate-to-severe UAO symptoms (Taussig ≥ 5), but Taussig ≥ 5 was less frequent in patients less than 2 years-of-age treated with steroids (p = 0.014). Median Taussig score was lower in the dexamethasone group 1 h after extubation, p < 0.001. 27 patients required reintubation, 9 due to UAO: 3 (4.3%) in the dexamethasone group and 6 (8.9%) in the placebo group, p = 0.319. In those intubated > 5 days, reintubation due to UAO was higher in the placebo group (2.4% vs. 14.3, p = 0.052). Nebulized epinephrine and budesonide were required more frequently in the placebo group in the first 2 h (p = 0.041) and 1 h (p = 0.02) after extubation, respectively. No relevant side effects were observed. Dexamethasone prior to extubation did not significantly reduce moderate-severe UAO symptoms, except for patients under 2-years of age. Dexamethasone could decrease Taussig score and the need of rescue therapies, as well as reintubation rates in those intubated for more than 5 days.

Factors Associated With Post-Extubation Stridor in Infants Intubated in the Pediatric ICU

“…A recent randomized controlled trial found pre-extubation dexamethasone reduced UAO symptoms in patients less than 2 years of age. 15 This study found preextubation dexamethasone use was associated with PES and heliox administration, contrary to expectation. This likely reflects clinical data available to providers raising concern for the possibility of PES that was unavailable in the EMR, such as the absence of a leak, leading to empiric administration of dexamethasone in patients deemed to be at high risk for PES rather than true risk conferred by dexamethasone.…”

Pre-Extubation Ultrasound Measurement of In Situ Cuffed Endotracheal Tube Laryngeal Air Column Width Difference: Single-Center Pilot Study of Relationship With Post-Extubation Stridor in Subjects Younger Than 5 Years Old

“…Recent evidence supports the early administration of glucocorticoids to prevent post-extubation UAO (8, 9). A pragmatic approach based on our results in subjects younger than 5 years old could be, at the time of extubation readiness, as follows.…”

“…Post-extubation UAO is difficult to predict as the proximal airway cannot be reliably assessed before extubation with the endotracheal tube (ETT) in place (5,6). While UAO can occur along the entire airway axis, most attention is focused on subglottic UAO, manifesting as stridor because it is treatable before and after extubation (7)(8)(9). Clinical assessment of the subglottic airway before extubation traditionally relies on the airway leak test (ALT) which is neither sensitive (27-55%) nor specific (35-81%) for identifying post-extubation UAO in pediatric patients (10).…”

“…Clinical assessment of the subglottic airway before extubation traditionally relies on the airway leak test (ALT) which is neither sensitive (27–55%) nor specific (35–81%) for identifying post-extubation UAO in pediatric patients (10). Treatment of patients at high risk for subglottic UAO with glucocorticoids can decrease post-extubation stridor (PES) (8, 9). At the same time, the administration of glucocorticoids can be spared in patients at low risk for developing PES.…”

Air leak test in the Paediatric Intensive Care Unit (ALTIPICU): rationale and protocol for a prospective multicentre observational study

“…However, to differentiate PERD due to UAO versus other causes, the Westley score has to include at least 1 point for stridor. Thus, use of the interventions is linked to objective evidence of respiratory distress 29–31. UAO-PERD shares pathophysiological similarities with croup.…”