High-flow nasal oxygen during transfemoral TAVR
Uso de Lentillas de Alto Flujo en Procedimientos de sustitución de válvula aórtica transcatéter. Impacto en Las Complicaciones Respiratorias y Biomarcado- Res y Resultados clínicos. TAVR-Highflow
This tests whether using high-flow nasal oxygen during sedation prevents low oxygen levels in adults undergoing elective transfemoral TAVR.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 452 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Clinic of Barcelona Academic / other |
| Locations | 1 site (Barcelona, Barcelona) |
| Trial ID | NCT07059728 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares two oxygen strategies during sedation for elective transfemoral TAVR: high-flow nasal cannula delivering 60 L/min at 60% FiO2 versus standard nasal cannula at 5 L/min. Adult patients scheduled for elective transfemoral TAVR at Hospital Clinic de Barcelona who meet inclusion and exclusion criteria are enrolled and receive the assigned oxygen therapy during the procedure. Primary outcomes include peri-procedural hypoxemia, need for airway interventions, and conversion to general anesthesia, with continuous monitoring of oxygenation and hemodynamics. Patients with non-femoral access, planned general anesthesia, basal skull fracture, pneumothorax, or very short procedures (<45 minutes) are excluded.
Who should consider this trial
Good fit: Ideal candidates are adults (>18) scheduled for elective transfemoral TAVR who are planned to undergo the procedure under sedation rather than planned general anesthesia.
Not a fit: Patients planned for general anesthesia, those with non-femoral access, basal skull fracture or pneumothorax, or procedures under 45 minutes are unlikely to benefit from the intervention tested here.
Why it matters
Potential benefit: If successful, high-flow nasal oxygen could lower rates of hypoxemia and reduce the need for airway support or conversion to general anesthesia during TAVR.
How similar studies have performed: High-flow nasal oxygen has shown reduced desaturation in other procedural and perioperative settings, but evidence specific to sedated TAVR patients is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Transfemoral TAVR elective procedure * Age \>18 years Exclusion Criteria: * Patients under 18 years of age * Refusal to participate * Known allergy to propofol or remifentanil. * Non-femoral surgical access. * Presence of a basal skull fracture or pneumothorax * Procedure duration \< 45 minutes * Previously planned general anaesthesia approach due to patient's condition or procedural technical reasons * Need to convert to general anesthesia for non-respiratory complications within 45 minutes.
Where this trial is running
Barcelona, Barcelona
- Hospital Clinic de Barcelona — Barcelona, Barcelona, Spain (Recruiting)
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.