Evaluation of hyperbaric oxygen therapy (hyperbaric chamber) in the treatment of vaso-occlusive crisis in sickle cell patients over 8 years old
Summary description of the study
This study aims to investigate the treatment with pure oxygen administered under pressure (Hyperbaric Oxygen Therapy or HBO) using a hyperbaric chamber in patients with sickle cell disease presenting to the emergency department for a vaso-occlusive crisis (VOC or acute painful crisis complicating this disease). The principle is to randomly assign patients who will receive the real treatment and those who will receive the placebo. Patients randomized to the intervention arm will receive treatment consisting of a session of hyperbaric oxygen therapy, that is, a session in the chamber with increased pressure and pure oxygen. Patients randomized to the placebo arm will also be treated in the chamber without increasing pressure or using pure oxygen. Neither the patients nor the investigators will know the nature of the treatment received. HBO could currently already be used in sickle cell disease as a consensus conference has recognized its indication, but without being certain of its effectiveness, which must therefore be demonstrated in the VOC, which is the aim of this study. This study should include 100 adult and child patients over 8 years old and should last 2 years. It will take place at two sites: Geneva and Lyon (France). The objective is to rapidly decrease the intensity of pain caused by the VOC and thus allow for a rapid reduction in the doses of morphine typically used in these situations.
(BASEC)
Intervention under investigation
The principle is to randomly assign patients who will receive the treatment with HBO and those who will receive the placebo.
All patients will be invited to enter the chamber for about 2 hours, accompanied by a specialized collaborator. They will then receive either the real treatment (increased pressure and pure oxygen) or a placebo (very slight increase in pressure and ambient air instead of oxygen).
The duration of the sessions is 95 minutes (whether in the intervention or placebo arm).
(BASEC)
Disease under investigation
Vaso-occlusive crisis in sickle cell patients presenting to the emergency department, occurring in the context of sickle cell disease
(BASEC)
Patients who meet all of the following criteria may be included in this study: - Patient over 8 years old; - Patient with sickle cell disease. - Patient presenting to the emergency department for a vaso-occlusive crisis not responding to simple analgesics. - Able to perform Valsalva maneuvers (equalizing ear pressure by blowing while pinching the nose and closing the mouth). - Patient who has signed informed consent. (BASEC)
Exclusion criteria
Patients who meet at least 1 of the following criteria cannot be included: - Current pregnancy; - Indication for artificial ventilation; - Proven contraindication to hyperbaric oxygen therapy established by a hyperbaric physician (a specialized physician will conduct a systematic consultation before any session); - Transcranial Doppler anomaly (> 200 cm/sec) found in the follow-up of children or history of stroke; - Oxygen needs greater than 2 l/min with nasal cannula. (BASEC)
Trial sites
Geneva, Other
(BASEC)
Lyon (France) Toulouse (France)
(BASEC)
Sponsor
Jérôme Stirnemann, HUG
(BASEC)
Contact
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Geneva
(BASEC)
Date of authorisation
06.05.2021
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Evaluation de l’oxygénothérapie hyperbare (caisson hyperbare) dans le traitement de la crise vaso-occlusive chez le patient drépanocytaire de plus de 8 ans (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
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Additional contacts
not available
Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available