Using nasal oxygen therapy to reduce complications after ankle surgery in high-risk patients
Efficacy of Nasal Oxygen Therapy to Reduce Postoperative Complications in Ankle Trauma Surgery in At-risk Patients: a Randomized Pilot Study
This study is testing if giving nasal oxygen to high-risk patients after ankle surgery can help them heal better and avoid complications compared to standard care without oxygen.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nantes) |
| Trial ID | NCT05185115 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effectiveness of nasal oxygen therapy in reducing postoperative complications in patients undergoing ankle trauma surgery. A total of 200 patients will be randomly assigned to receive either oxygen therapy or standard care without oxygen during their hospitalization. The study will monitor various outcomes, including complication rates, quality of healing, and pain levels for up to six months post-surgery. Additionally, a subgroup of 40 patients will undergo transcutaneous oxygen pressure measurements to assess tissue oxygenation differences between the two groups.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with ankle fractures and at least one risk factor for surgical complications.
Not a fit: Patients with chronic respiratory issues, sleep apnea requiring equipment, or those on long-term oxygen therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications and improve recovery outcomes for high-risk patients undergoing ankle surgery.
How similar studies have performed: While nasal oxygen therapy has been used in various contexts, this specific application in ankle surgery is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nantes
- Dr Gadbed — Nantes, France (Recruiting)
Study contacts
- Study coordinator: Guillaume Gadbled, PH
- Email: guillaume.gadbled@chu-nantes.fr
- Phone: 02 40 08 37 78
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.