Prone positioning in non-intubated patients with COVID-19 associated acute respiratory failure, the PRO-CARF trial: A st
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LETTER
Open Access
Prone positioning in non-intubated patients with COVID-19 associated acute respiratory failure, the PRO-CARF trial: A structured summary of a study protocol for a randomised controlled trial Miguel Á. Ibarra-Estrada1* , Miguel Marín-Rosales2, Roxana García-Salcido3, Sara A. Aguirre-Díaz4, Alexandra Vargas-Obieta1, Quetzalcóatl Chávez-Peña1,5, José A. López-Pulgarín5,6, Julio C. Mijangos-Méndez1 and Guadalupe Aguirre-Avalos5,6
Abstract Objectives: To assess the effect of prone positioning therapy on intubation rate in awake patients with COVID-19 and acute respiratory failure. Trial design: This is a two-center parallel group, superiority, randomized (1:1 allocation ratio) controlled trial. Participants: All patients admitted to the Hospital Civil de Guadalajara and Hospital General de Occidente in Mexico for COVID-19 associated acute respiratory failure and in need of supplementary oxygen through high-flow nasal cannula are screened for eligibility. Inclusion criteria: all adult patients admitted to the COVID-19 unit who test positive for COVID-19 by PCR-test and in need for oxygen are eligible for inclusion. Randomization starts upon identification of requirement of a fraction of inspired oxygen ≥30% for an oxygen capillary saturation of ≥90% Exclusion criteria: less than 18 years-old, pregnancy, patients with immediate need of invasive mechanical ventilation (altered mental status, fatigue), vasopressor requirement to maintain median arterial pressure >65 mmHg, contraindications for prone positioning therapy (recent abdominal or thoracic surgery or trauma, facial, pelvic or spine fracture, untreated pneumothorax, do-not-resuscitate or do-not-intubate order, refusal or inability of the patient to enroll in the study. (Continued on next page)
* Correspondence: [email protected] 1 Intensive Care Unit, COVID-19 Unit, Hospital Civil Fray Antonio Alcalde, Guadalajara, Jalisco, Mexico 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
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