NOrmoBaric Oxygen Therapy Use In Critical Limb ISchemia

Condition(s) studied

Investigational drug(s) / intervention(s)

introduction of oxygen therapy or not: During hospitalisation, surgeon decides if patient needs and will have an oxygen therapy during this hospitalisation and at home.

Study summary

Peripheral arteriopathy disease (PAD) affects 1 million people in France. In its most advanced stage: chronic permanent ischemia also called critical ischemia, the prognosis of patients is burdened with a one-year mortality rate of 30%. Chronic permanent ischemia results from a lack of oxygen supply to the microcirculatory network, responsible for tissue death and the development of trophic disorders. In this context, many studies have focused on the contribution of hyperbaric oxygen therapy, however none demonstrates with certainty its beneficial effect with a heavy set-up for teams and patients. Furthermore, it appears that normobaric oxygen therapy could have its place in this context by temporarily restoring a sufficient level of transcutaneous oxygen. However, even if normobaric oxygen therapy is common practice although empirical for some practitioners, no data demonstrates its real interest. The purpose of this study is therefore to report the proportion, in usual practice, of patients with permanent chronic ischemia of the lower limb(s), benefiting from normobaric oxygen therapy, but also to show the interest of the contribution of this therapy in usual comprehensive management of these patients. This is a pilot study, after which, if the hypothesis is confirmed, it may be proposed to carry out a randomized study, on a large scale, in order to validate the use of normobaric oxygen therapy in the context of chronic permanent ischemia.

Eligibility

Primary outcome measure(s)

• Comparison of clinical characteristics of patients, whether or not they benefit from oxygen therapy in usual practices. — 6 months
  Determination of patients' characteristic with or without a prescription of oxygen therapy to inventorized clinical practices.
• Comparison of biological characteristics of patients, whether or not they benefit from oxygen therapy in usual practices. — 6 months
  Determination of patients' characteristics with or without a prescription of oxygen therapy to inventorized clinical practices.

Trial sites (3)

More University Hospital, Angers trials in France