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

Nantes University Hospital (NUH)

Status and phase: Active, not recruiting; Phase 3

Conditions: Ankle Fractures

Treatments: Other: no oxygen therapy; Drug: Oxygen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05185115

RC21_0129

Details and patient eligibility

About

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

Full description

Prospective, single-center, comparative and randomized study based on a cohort of 200 patients with an ankle fracture. The patients will be assigned to one of the following group: with or without oxygen therapy. Patients in the experimental group will receive the oxygen just before the operation, and during the hospitalization. The rest of the care is the same for the 2 groups. Comparison of complication rate, of quality of healing, rate of revision surgery, delay in bone healing, rate of pseudoarthrosis, and ankle pain will be done between the 2 groups during a postoperative period of 6 months. A cost-utility analysis will also be realized. In a subgroup of 40 patients, additional transcutaneous oxygen pressure measurements will be performed to compare the evolution of tissue oxygenation between the 2 groups.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Intervention group (A)

Experimental group

Description:

Patients treated with 3 liters per minute oxygen delivered via nasal cannula duration hospitalization

Treatment:

Drug: Oxygen

Control group (B)

Other group

Description:

No oxygen therapy during hospitalization

Treatment:

Other: no oxygen therapy