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

Launched by NANTES UNIVERSITY HOSPITAL · Jan 10, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether nasal oxygen therapy can help prevent complications after ankle surgery in patients who are more likely to face problems during recovery. Ankle fractures are common and can lead to issues like infections or poor healing, especially in patients with certain health risks, such as diabetes or those who smoke. In this study, 200 participants will be divided into two groups: one group will receive nasal oxygen therapy during their hospital stay, while the other group will not. The researchers will track the rates of complications for up to six months after the surgery to see if the oxygen therapy makes a difference.

To be eligible for this study, participants need to be over 18 years old and have an ankle injury that requires surgery. They should also have at least one health risk factor that could lead to complications, such as diabetes or a complex fracture. However, individuals with certain conditions, like chronic breathing problems or pregnant women, cannot participate. If you join the trial, you can expect to receive either the nasal oxygen therapy or standard care during your hospital stay, and you'll be followed up for several months to monitor your recovery. This study aims to provide valuable insights into whether nasal oxygen therapy can improve recovery for patients undergoing ankle surgery.

Gender

ALL

Eligibility 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