Efficacy of prophylactic methylprednisolone on reducing the risk of post-extubation stridor in an emergency setting: study protocol for a randomized controlled trial
Background: Post-extubation stridor (PES) is one of common complications of invasive respiratory support, with severe cases leading to extubation failure (need reintubation within 48 hours after extubation) and increased mortality. Previous studies confirmed that prophylactic corticosteroids play an important role in reducing the risk of PES and extubation failure. However, few study the efficacy of corticosteroid on preventing PES in patients with an emergency intubation. Aim: To evaluate
... m: To evaluate whether a single dose of methylprednisolone given over a set time-frame before extubation is effective in preventing PES in patients with an emergency intubation. Methods: A multicenter, randomized, placebo-controlled trial will be performed. The trial will include 242 patients who fail the cuff-leak test (CLT) in the intervention. The patients will be randomly assigned to either intravenous methylprednisolone 40mg or placebo four hours prior to extubation. Other eligible patients who pass the CLT will be included in non-intervention (observation). The primary endpoint is the incidence of PES within 48 hours after extubation, the secondary endpoints are the oxygen therapy, requirement for respiratory support, reintubation secondary to PES, adverse effects within 48 hours after extubation, hospital length of stay and hospital mortality.Discussion: Patients who are intubated on an emergency basis have a higher risk of intubation-related complications due to some inevitable reasons. Earlier studies showed more than 10 different corticosteroids treatments on PES prevention, while only a simple and effective treatment will be appropriate for Emergency Department therapy. Additionally, corticosteroids administration is usually companied by adverse effects, thus the recording of adverse effects is important for further pros and cons analysis of prophylactic corticosteroid use among emergency patients. Trial registration: Chictr.org.cn, ChiCTR2000030349. Registered on 29 Feb 2020.