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COVID-19-Induced Acute Respiratory Distress Syndrome Treated with Hyperbaric Oxygen: Interim Safety Report from a Randomized Clinical Trial (COVID-19-HBO)
Background: A few prospective trials and case series have suggested that hyperbaric oxygen therapy (HBOT) may be efficacious for the treatment of severe COVID-19, but safety is a concern for critically ill patients. We present an interim analysis of the safety of HBOT via a randomized controlled tri...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10381696/ https://www.ncbi.nlm.nih.gov/pubmed/37510965 http://dx.doi.org/10.3390/jcm12144850 |
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author | Kjellberg, Anders Douglas, Johan Hassler, Adrian Al-Ezerjawi, Sarah Boström, Emil Abdel-Halim, Lina Liwenborg, Lovisa Hetting, Eric Jonasdottir Njåstad, Anna Dora Kowalski, Jan Catrina, Sergiu-Bogdan Rodriguez-Wallberg, Kenny A. Lindholm, Peter |
author_facet | Kjellberg, Anders Douglas, Johan Hassler, Adrian Al-Ezerjawi, Sarah Boström, Emil Abdel-Halim, Lina Liwenborg, Lovisa Hetting, Eric Jonasdottir Njåstad, Anna Dora Kowalski, Jan Catrina, Sergiu-Bogdan Rodriguez-Wallberg, Kenny A. Lindholm, Peter |
author_sort | Kjellberg, Anders |
collection | PubMed |
description | Background: A few prospective trials and case series have suggested that hyperbaric oxygen therapy (HBOT) may be efficacious for the treatment of severe COVID-19, but safety is a concern for critically ill patients. We present an interim analysis of the safety of HBOT via a randomized controlled trial (COVID-19-HBO). Methods: A randomized controlled, open-label, clinical trial was conducted in compliance with good clinical practice to explore the safety and efficacy of HBOT for severe COVID-19 in critically ill patients with moderate acute respiratory distress syndrome (ARDS). Between 3 June 2020, and 17 May 2021, 31 patients with severe COVID-19 and moderate-to-severe ARDS, a ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO(2)/FiO(2)) < 26.7 kPa (200 mmHg), and at least two defined risk factors for intensive care unit (ICU) admission and/or mortality were enrolled in the trial and randomized 1:1 to best practice, or HBOT in addition to best practice. The subjects allocated to HBOT received a maximum of five treatments at 2.4 atmospheres absolute (ATA) for 80 min over seven days. The subjects were followed up for 30 days. The safety endpoints were analyzed. Results: Adverse events (AEs) were common. Hypoxia was the most common adverse event reported. There was no statistically significant difference between the groups. Numerically, serious adverse events (SAEs) and barotrauma were more frequent in the control group, and the differences between groups were in favor of the HBOT in PaO(2)/FiO(2) (PFI) and the national early warning score (NEWS); statistically, however, the differences were not significant at day 7, and no difference was observed for the total oxygen burden and cumulative pulmonary oxygen toxicity dose (CPTD). Conclusion: HBOT appears to be safe as an intervention for critically ill patients with moderate-to-severe ARDS induced by COVID-19. Clinical trial registration: NCT04327505 (31 March 2020) and EudraCT 2020-001349-37 (24 April 2020). |
format | Online Article Text |
id | pubmed-10381696 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-103816962023-07-29 COVID-19-Induced Acute Respiratory Distress Syndrome Treated with Hyperbaric Oxygen: Interim Safety Report from a Randomized Clinical Trial (COVID-19-HBO) Kjellberg, Anders Douglas, Johan Hassler, Adrian Al-Ezerjawi, Sarah Boström, Emil Abdel-Halim, Lina Liwenborg, Lovisa Hetting, Eric Jonasdottir Njåstad, Anna Dora Kowalski, Jan Catrina, Sergiu-Bogdan Rodriguez-Wallberg, Kenny A. Lindholm, Peter J Clin Med Article Background: A few prospective trials and case series have suggested that hyperbaric oxygen therapy (HBOT) may be efficacious for the treatment of severe COVID-19, but safety is a concern for critically ill patients. We present an interim analysis of the safety of HBOT via a randomized controlled trial (COVID-19-HBO). Methods: A randomized controlled, open-label, clinical trial was conducted in compliance with good clinical practice to explore the safety and efficacy of HBOT for severe COVID-19 in critically ill patients with moderate acute respiratory distress syndrome (ARDS). Between 3 June 2020, and 17 May 2021, 31 patients with severe COVID-19 and moderate-to-severe ARDS, a ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO(2)/FiO(2)) < 26.7 kPa (200 mmHg), and at least two defined risk factors for intensive care unit (ICU) admission and/or mortality were enrolled in the trial and randomized 1:1 to best practice, or HBOT in addition to best practice. The subjects allocated to HBOT received a maximum of five treatments at 2.4 atmospheres absolute (ATA) for 80 min over seven days. The subjects were followed up for 30 days. The safety endpoints were analyzed. Results: Adverse events (AEs) were common. Hypoxia was the most common adverse event reported. There was no statistically significant difference between the groups. Numerically, serious adverse events (SAEs) and barotrauma were more frequent in the control group, and the differences between groups were in favor of the HBOT in PaO(2)/FiO(2) (PFI) and the national early warning score (NEWS); statistically, however, the differences were not significant at day 7, and no difference was observed for the total oxygen burden and cumulative pulmonary oxygen toxicity dose (CPTD). Conclusion: HBOT appears to be safe as an intervention for critically ill patients with moderate-to-severe ARDS induced by COVID-19. Clinical trial registration: NCT04327505 (31 March 2020) and EudraCT 2020-001349-37 (24 April 2020). MDPI 2023-07-24 /pmc/articles/PMC10381696/ /pubmed/37510965 http://dx.doi.org/10.3390/jcm12144850 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Kjellberg, Anders Douglas, Johan Hassler, Adrian Al-Ezerjawi, Sarah Boström, Emil Abdel-Halim, Lina Liwenborg, Lovisa Hetting, Eric Jonasdottir Njåstad, Anna Dora Kowalski, Jan Catrina, Sergiu-Bogdan Rodriguez-Wallberg, Kenny A. Lindholm, Peter COVID-19-Induced Acute Respiratory Distress Syndrome Treated with Hyperbaric Oxygen: Interim Safety Report from a Randomized Clinical Trial (COVID-19-HBO) |
title | COVID-19-Induced Acute Respiratory Distress Syndrome Treated with Hyperbaric Oxygen: Interim Safety Report from a Randomized Clinical Trial (COVID-19-HBO) |
title_full | COVID-19-Induced Acute Respiratory Distress Syndrome Treated with Hyperbaric Oxygen: Interim Safety Report from a Randomized Clinical Trial (COVID-19-HBO) |
title_fullStr | COVID-19-Induced Acute Respiratory Distress Syndrome Treated with Hyperbaric Oxygen: Interim Safety Report from a Randomized Clinical Trial (COVID-19-HBO) |
title_full_unstemmed | COVID-19-Induced Acute Respiratory Distress Syndrome Treated with Hyperbaric Oxygen: Interim Safety Report from a Randomized Clinical Trial (COVID-19-HBO) |
title_short | COVID-19-Induced Acute Respiratory Distress Syndrome Treated with Hyperbaric Oxygen: Interim Safety Report from a Randomized Clinical Trial (COVID-19-HBO) |
title_sort | covid-19-induced acute respiratory distress syndrome treated with hyperbaric oxygen: interim safety report from a randomized clinical trial (covid-19-hbo) |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10381696/ https://www.ncbi.nlm.nih.gov/pubmed/37510965 http://dx.doi.org/10.3390/jcm12144850 |
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