Randomised, controlled, open label, multicentre clinical trial to explore safety and efficacy of hyperbaric oxygen for preventing ICU admission, morbidity and mortality in adult patients with COVID-19

Abstract

IntroductionCOVID-19 may cause severe pneumonitis and trigger a massive inflammatory response that requires ventilatory support. The intensive care unit (ICU)-mortality has been reported to be as high as 62%. Dexamethasone is the only of all anti-inflammatory drugs that have been tested to date that has shown a positive effect on mortality. We aim to explore if treatment with hyperbaric oxygen (HBO) is safe and effective for patients with severe COVID-19. Our hypothesis is that HBO can prevent ICU admission, morbidity and mortality by attenuating the inflammatory response. The primary objective is to evaluate if HBO reduces the number of ICU admissions compared with best practice treatment for COVID-19, main secondary objectives are to evaluate if HBO reduces the load on ICU resources, morbidity and mortality and to evaluate if HBO mitigates the inflammatory reaction in COVID-19.Methods and analysisA randomised, controlled, phase II, open label, multicentre trial. 200 subjects with severe COVID-19 and at least two risk factors for mortality will be included. Baseline clinical data and blood samples will be collected before randomisation and repeated daily for 7 days, at days 14 and 30. Subjects will be randomised with a computer-based system to HBO, maximum five times during the first 7 days plus best practice treatment or only best practice treatment. The primary endpoint, ICU admission, is defined by criteria for selection for ICU. We will evaluate if HBO mitigates the inflammatory reaction in COVID-19 using molecular analyses. All parameters are recorded in an electronic case report form. An independent Data Safety Monitoring Board will review the safety parameters.Ethics and disseminationThe trial is approved by The National Institutional Review Board in Sweden (2020-01705) and the Swedish Medical Product Agency (5.1-2020-36673). Positive, negative and any inconclusive results will be published in peer-reviewed scientific journals with open access.Trial registrationNCT04327505. EudraCT number: 2020-001349-37.

Multifactor Logistic Analysis to Explore the Risk Factors of Safety Risks in the Transport of Critically Ill Patients with ICU and the Improvement of Nursing Strategies

“…The side effects of the patients during the transfer may be related to the patient's condition, the excellent transfer equipment, the ability of the transfer personnel or the communication between the teams, the preparation before the transfer, and the monitoring during the transfer [ 8 ]. According to reports of adverse events during in-hospital transport, patients had different types of complications during in-hospital transport, of which 42.4% of the complications were related to hypoxia [ 9 ]. Some scholars reported that during the transfer of surgical patients to the ward, about 30% to 50% of patients developed hypoxemia after operation.…”

Can Hyperbaric Oxygen Therapy Be Used to Treat Children after COVID-19? A Bibliographic Review

“…However, the authors of the present study believe that studies conducted on an older population can be the basis for the analysis of the positive effects of HBOT on pediatric patients following COVID-19 who are struggling with complications. Knowing the general effects of hyperbaric oxygen therapy including the alleviation of general inflammation by reducing the expression of TLR2 and TLR4 receptors and polarizing cytokine-secreting macrophages (and thus preventing acute respiratory failure), reducing fatigue and improving cognitive abilities, reducing tissue edema and improving tissue oxygenation, and antimicrobial activity [ 14 , 32 , 33 ], it can be expected that its effect will also be positive in the treatment of children with the pediatric inflammatory multisystem syndrome (PIMS, MIS-C) developed as a complication of COVID-19, and the treatment of other complications such as pediatric acute respiratory distress syndrome (PARDS). Both the occurrence of MIS-C and PARDS are likely to be initiated by the secretion of large amounts of pro-inflammatory cytokines and lead to multi-organ dysfunction [ 9 ].…”

Hyperbaric oxygen for treatment of long COVID-19 syndrome (HOT-LoCO): protocol for a randomised, placebo-controlled, double-blind, phase II clinical trial

“…HBOT has previously been used as an adjunctive treatment for COVID-19, resulting in faster recovery in prospective trials, case series 13 and a randomised controlled trial (RCT), 14 with additional RCTs ongoing. 15 The rationale for treatment of COVID-19 with HBOT is the treatment’s well-established anti-inflammatory effects. 16 17 Furthermore, a small retrospective cohort study has shown promising results in alleviating symptoms of long COVID-19 in patients treated with HBOT.…”

“…Hyperbaric oxygen therapy (HBOT) is administered by delivering 100% oxygen at raised pressure to patients in a hyperbaric chamber. HBOT has previously been used as an adjunctive treatment for COVID-19, resulting in faster recovery in prospective trials, case series13 and a randomised controlled trial (RCT),14 with additional RCTs ongoing 15. The rationale for treatment of COVID-19 with HBOT is the treatment’s well-established anti-inflammatory effects 16 17.…”