NOrmoBaric Oxygen Therapy Use In Critical Limb ISchemia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

hospitalized patient with symptoms of chronic permanent ischemia

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • introduction of oxygen therapy or not

    Procedure/Surgery

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: hospitalized patients suspected of chronic permanent ischemia realizing transcutaneous oxymetry1 intervention

Trial outcomes

Primary outcomes

1

Comparison of clinical characteristics of patients, whether or not they benefit from oxygen therapy in usual practices.

Determination of patients' characteristic with or without a prescription of oxygen therapy to inventorized clinical practices.

Time frame
6 months
2

Comparison of biological characteristics of patients, whether or not they benefit from oxygen therapy in usual practices.

Determination of patients' characteristics with or without a prescription of oxygen therapy to inventorized clinical practices.

Time frame
6 months

Secondary outcomes

1

Collection of all investigations carried out since inclusion and all modifications of medical therapy or implementation of surgical treatment.

Descriptive study of investigations and therapies (medical and surgical) carried out during the patient's follow-up period

Time frame
6 months
2

prevalence of decision-making parameters by using the sheet sent to the prescribing doctor by the patient.

Descriptive study of the parameter(s) which allowed the prescriber to make the decision to implement oxygen therapy.

Time frame
6 months
3

difference in the WIfI score items at inclusion and at 6 months.

Evaluation of the evolution of chronic permanent ischemia according to the administration in current practice of normobaric oxygen therapy.

Time frame
6 months
4

All-cause mortality at 6 months.

Evaluation of the evolution of chronic permanent ischemia according to the administration in current practice of normobaric oxygen therapy.

Time frame
6 months

Other outcomes

Sponsors and contacts

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