Efficacy of Nasal Oxygen Therapy to Reduce Postoperative Complications in Ankle Trauma Surgery in At-risk Patients: a Randomized Pilot Study.

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Ankle fractures are one of the most common surgeries in the world. After this kind of surgery, complications can occur, related to the scar or an infection. These complications are more frequent in "high-risk" patients. Nasal oxygen therapy is currently used in order to reduce these complications. However, no study proved its efficiency yet. In a cohort of 200 patients, one group will receive oxygen therapy during hospitalization, while the other will not. Complication rates will be observed up to 6 months after the operation

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Collaborator: Radiometer Medical ApS

Criteria

Inclusion Criteria:

• Patient over 18 years of age

• Patient with an ankle joint injury with surgical indication

• Patient with at least one risk factor for scar complication such as comorbidity(ies) (diabetes, smoking, peripheral neuropathy, obstructive arterial disease of the lower limbs, microangiopathy, treatment influencing healing (chemotherapy, corticosteroids...)) and/or complex fracture

• Patient affiliated to a social security system

• Patient having signed an informed consent

Exclusion Criteria:

• Patient with chronic respiratory insufficiency

• Patient with sleep apnea with equipment

• Patient under long term oxygen therapy

• Patient with a bilateral ankle fracture

• Polytrauma patients

• Pregnant or breastfeeding women or those refusing effective contraception

• Patient deprived of liberty or under legal protection (guardianship or curatorship)

• Patient unable to follow the protocol, as judged by the investigator

• Patient refusing to participate in the study