Status:
UNKNOWN
Management by Hyperbaric Oxygen Therapy of Patients With Hypoxaemic Pneumonia With SARS-CoV-2 (COVID-19)
Lead Sponsor:
Direction Centrale du Service de Santé des Armées
Conditions:
Covid-19
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
PHASE3
Brief Summary
Several patients with hypoxaemic SARS-CoV2 pneumonia were able to benefit from hyperbaric oxygen treatment (HBOT) in China. In a clinical case published in the Chinese journal of hyperbaric medicine, ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04344431
Start Date
April 14 2020
End Date
April 1 2022
Last Update
February 15 2022
Active Locations (3)
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1
Hôpital d'Instruction des Armées Laveran
Marseille, France, 13013
2
Centre Hospitalier Intercommunal de Toulon - La Seyne-sur-Mer
Toulon, France, 83100
3
Hôpital d'Instruction des Armées Sainte-Anne
Toulon, France, 83130