Several patients with hypoxaemic SARS-CoV2 pneumonia were able to benefit from hyperbaricoxygen treatment (HBOT) in China. In a clinical case published in the Chinese journal ofhyperbaric medicine, treatment with repeated HBO sessions prevented admission tointensive care unit with mechanical ventilation in a patient aged 69 who presented withsigns of respiratory decompensation. HBOT is the most powerful oxygenation modality inthe body today. HBOT can dramatically increase the amount of dissolved oxygen in theblood. HBOT not only promotes blood transport but also its tissue delivery. Furthermore,HBOT has specific immunomodulatory properties, both humoral and cellular, making itpossible, for example, to reduce the intensity of the inflammatory response and tostimulate antioxidant defenses by repeating sessions. A virucidal capacity of HBOT mightalso be involved. HBOT is generally regarded as safe with very few adverse events.Following this feedback, it is proposed in the context of crisis management related toSARS-CoV2 to assess the value of HBO treatment of patients with CoV2 pneumonia. Indeed,it seems essential to propose therapeutic strategies to limit the risk of respiratorydecompensation requiring admission to intensive care unit for patients with SARS-CoV2pneumonia.
The main objective of this study is to assess the effectiveness of HBOT in addition to
normal management over the period of normalization of the oxygen requirement (oxygen
dependence) in patients with SAR-CoV2 pneumonia not requiring invasive or non-invasive
ventilation. It is a prospective, interventional, multicentre, controlled, randomized
study. Patients admitted for SARS-CoV2 pneumonia in the Covid sector of the hospital, who
have oxygen-dependence criteria will be proposed for inclusion in accordance with the
inclusion and non-inclusion criteria. Randomization will be carried out to determine the
allocation in two groups: an HBO group which will perform a daily session after checking
for the absence of contraindication to HBO and a non-HBO control group with the same
clinical criteria, but who will not benefit from HBOT sessions. In both groups, the
standard continuous treatment with normobaric oxygen will be maintained.
Combination Product: Hyperbaric oxygen treatment (HBOT) i.e. inhalation of pressurized oxygen delivered by a hyperbaric chamber (drug/device)
One session per day of HBOT in addition to the standard treatment with normobaric oxygen
Inclusion Criteria:
- Male or female, Age ≥ 18 years
- Patient with oxygen dependence criterion: need to maintain an oxygen flow rate less
than or equal to 6 liters / min to obtain: saturation by pulse oximetry (SpO2)
greater than or equal to 92% or arterial gas with value PaO2 greater than 60mmHg.
- Diagnostic confirmation of SARS-CoV-2 pneumonia
Exclusion Criteria:
- Minor subject (age <18 years)
- Person unable to give consent
- Refusal to participate
- Pregnancy
- Participating in another research
- Signs of respiratory decompensation requiring mechanical ventilation
- Diagnosis of pneumonia with SARS-CoV-2 not confirmed
- Oxygen dependence criterion exceeded i.e. need to maintain an oxygen flow rate
greater than or equal to 6 liters / min to obtain: saturation by pulse oximetry
(SpO2) greater than or equal to 92% or arterial gas with value of PaO2 greater than
60mmHg.
- Inability to maintain the prolonged sitting position (at least 2 hours)
- Subject with contraindications to HBOT
Hôpital d'Instruction des Armées Laveran
Marseille, France
Centre Hospitalier Intercommunal de Toulon - La Seyne-sur-Mer
Toulon, France
Hôpital d'Instruction des Armées Sainte-Anne
Toulon, France
Jean-Eric BLATTEAU, MD, PhD
483162189 - +33
jean-eric.blatteau@intradef.gouv.fr
Jean-Eric BLATTEAU, MD, PhD, Principal Investigator
Sainte-Anne military hospital