RecruitingNCT06238050

NOrmoBaric Oxygen Therapy Use In Critical Limb ISchemia


Sponsor

University Hospital, Angers

Enrollment

200 participants

Start Date

Apr 15, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • Patient hospitalized in the recruiting centre.
  • Patient fulfilling the clinical and paraclinical criteria (resting TcpO2 values \< 30mmHg) of the definition of chronic permanent ischemia with or without trophic disorders.

Exclusion Criteria3

  • Patient suffering from acute or decompensated heart or respiratory failure.
  • Patient suffering from chronic obstructive pulmonary disease (COPD) stage III or IV.
  • Patient with allergies to medical adhesives

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Interventions

PROCEDUREintroduction of oxygen therapy or not

During hospitalisation, surgeon decides if patient needs and will have an oxygen therapy during this hospitalisation and at home.


Locations(3)

University Hospital

Angers, France

Hospital Center

Cholet, France

Hospital Center

Le Mans, France

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NCT06238050