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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-09

Study Completion Date

2026-10-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Ankle Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group (A)

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

Group Type EXPERIMENTAL

Oxygen

Intervention Type DRUG

administration of oxygen at a flow rate of 3 liters per minute, via nasal cannula throughout the hospitalization.

Control group (B)

No oxygen therapy during hospitalization

Group Type OTHER

no oxygen therapy

Intervention Type OTHER

No oxygen therapy during hospitalization

Interventions

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Oxygen

administration of oxygen at a flow rate of 3 liters per minute, via nasal cannula throughout the hospitalization.

Intervention Type DRUG

no oxygen therapy

No oxygen therapy during hospitalization

Intervention Type OTHER

Other Intervention Names

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O2

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No