Funding for this research was provided by:
Instituto de Salud Carlos III (EC11-077)
Text and Data Mining valid from 2020-04-19
Received: 8 August 2019
Accepted: 28 February 2020
First Online: 19 April 2020
Ethics approval and consent to participate
: This study protocol was designed in accordance with the Declaration of Helsinki (1964) and subsequent versions. The final version of this study protocol was approved by ethics committee of Gregorio Marañón Hospital, Madrid, Spain (IBHGM-ECNC003–2010) and the local ethics committee of all participating centers. The principal investigator will ensure that the study is performed in accordance with laws and regulations governing the performance of clinical trials and will communicate protocol modifications to relevant parties. The rationale for using placebo is that the effectiveness of steroids has not been confirmed to date and that other medications have not been proven to be effective in preventing post-extubation complications. The study investigator responsible for patient recruitment in each center will provide oral and written information on the study to the patients or their legal representatives when their age or clinical state prevents them from giving consent. Written informed consent will be required prior to inclusion. The local ethics committees will be given access to original records and databases.
: Not applicable.
: The authors declare that they have no competing interests. Neither participants nor investigators will receive any compensation for participating in this study.