The effect of surfactant on clinical outcome of patients with COVID-19 under mechanical ventilation: A structured summar
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Open Access
The effect of surfactant on clinical outcome of patients with COVID-19 under mechanical ventilation: A structured summary of a study protocol for a randomised controlled trial Ali Dabbagh1* , Samira Rajaei2, Mehdi Ghahremani3, Mohammad Fathi3, Nilofar Massoudi4, Sasan Tavana5, Kamal Fani6, Navid Nooraee3, Nasser Malekpour Alamdari7, Sara Besharat8, Arash Najafi Abrandabadi3, Ali Pirsalehi5 and Mohammad Ali Khabiri Khatiri3
Abstract Objectives: Assessing the effect of surfactant on clinical outcome in patients with COVID-19 under mechanical ventilation Trial design: Single centre, two arm, parallel group (1:1 allocation ratio), randomised superiority trial with blinded care and outcome assessment. Participants: Inclusion criteria: Adult COVID-19 patients admitted to the ICU in Modarres hospital, Tehran, Iran (age range of 18 to 99 years) with moderate to severe ARDS (based on definition of P/F ratio) requiring auxiliary respiratory devices (either intubation or face mask). Exclusion criteria: ● Existence of a major underlying pulmonary disease in addition to COVID-19 ● Underlying congenital heart disease ● Patients needing extracorporeal membrane oxygenation (ECMO) ● ARDS primarily due to any other reason rather than COVID-19 ● The primary source of pulmonary involvement was bacterial pneumonia or any other etiology except for COVID10 induced lung involvement ● Those who refused to continue the study (either the patient or their family) ● any patient had any sign of healing before entering the study leading to discharge from ICU in less than 12 hours (Continued on next page)
* Correspondence: [email protected] 1 Cardiac Anesthesiology Department, Anesthesiology Research Center, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Dabbagh et al. Trials
(2020) 21:919
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