Evaluation of hyperbaric oxygen therapy (hyperbaric chamber) in the treatment of vaso-occlusive crisis in sickle cell patients over 8 years old

Descrizione riassuntiva dello studio

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)

Intervento studiato

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)

Malattie studiate

Vaso-occlusive crisis in sickle cell patients presenting to the emergency department, occurring in the context of sickle cell disease

(BASEC)

Sponsor

Jérôme Stirnemann, HUG

(BASEC)

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione d'etica Ginevra

(BASEC)

Data di approvazione del comitato etico

06.05.2021

(BASEC)

Risultati dello studio