Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID-19: a pragmatic randomised clinical t
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Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID19: a pragmatic randomised clinical trial (COVID HELMET) Jonas Tverring* , Anna Åkesson and Niklas Nielsen
Abstract Background: Patients with COVID-19 and hypoxaemia despite conventional low-flow oxygen therapy are often treated with high-flow nasal cannula (HFNC) in line with international guidelines. Oxygen delivery by helmet continuous positive airway pressure (CPAP) is a feasible option that enables a higher positive end-expiratory pressure (PEEP) and may theoretically reduce the need for intubation compared to HFNC but direct comparative evidence is lacking. Methods: We plan to perform an investigator-initiated, pragmatic, randomised trial at an intermediate-level COVID19 cohort ward in Helsingborg Hospital, southern Sweden. We have estimated a required sample size of 120 patients randomised 1:1 to HFNC or Helmet CPAP to achieve 90% power to detect superiority at a 0.05 significance level regarding the primary outcome of ventilator free days (VFD) within 28 days using a Mann-Whitney U test. Patient recruitment is planned to being June 2020 and be completed in the first half of 2021. Discussion: We hypothesise that the use of Helmet CPAP will reduce the need for invasive mechanical ventilation compared to the use of HFNC without having a negative effect on survival. This could have important implications during the current COVID-19 epidemic. Trial registration: ClinicalTrials.gov NCT04395807. Registered on 20 May 2020 Keywords: COVID-19, Randomised controlled trial protocol, Helmet CPAP, HFNC, Ventilator-free days
* Correspondence: [email protected] Lunds universitet Medicinska fakulteten, Lund, Sweden © 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.
Tverring et al. Trials
(2020) 21:994
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Administrative information
disease but patients with severe or critical illness will require more advanced support [2]. Endotracheal intubation and mechanical ventilation const
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