NCT07059728 High Flow Nasal Oxygenation in Transcatheter Aortic Valve Replacement Procedures. TAVR-Highflow II
| NCT ID | NCT07059728 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Clinic of Barcelona |
| Condition | Aortic Stenosis Treated With TAVI |
| Study Type | INTERVENTIONAL |
| Enrollment | 452 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 452 participants in total. It began in 2025-02-01 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of patients with aortic valve disease. TAVR is a less invasive treatment compared to the conventional surgical approach through median sternotomy. Patients selected for this procedure often have a profile associated with multiple comorbidities which predispose them to certain complications. TAVI procedures were initially performed under general anesthesia. However, due to improved procedure times and anesthetic techniques, sedation has become the current trend to preform them. When sedation for these procedures requires deep planes, hypoxia is more likely to occur due to respiratory depression, apnea, or airway obstruction. This is even more common in TAVR patients population, as obesity, sleep apnea, elevated ASA classification, advanced age, and combined cardiorespiratory disease are highly prevalent. For all these reasons, TAVR constitutes a risky procedure, presenting a profile of patients undergoing this procedure that can also be considered high risk. The provision of supplemental oxygen through nasal cannulae or face masks can prevent the development of hypoxia. Unfortunately, non-humidified nasal oxygen cannot exceed 2-5 L/min without causing damage to the nasal mucosa, and the percentage of oxygen delivered through variable-flow face masks is unpredictable. On the other hand, high-flow nasal oxygen therapy (HFNO) can provide humidified gas flow rates of up to 70 L/min through specially adapted nasal cannulae and reliably deliver oxygen concentrations between 21% and 100%. The use of HFNC could be justified in this context and could improve the outcomes and safety of these procedures, increasing oxygen content and minimizing hypercapnia. The study's hypothesis is HFNO will prevent hypoxemia and control hypercapnia during sedation for transcatheter aortic valve implantation (TAVI) better than conventional oxygen theraphy. Clinical and serological biomarkers of tissue injury will decrease with the use of HFNO. Clinical complications will decrease with the use of HFNO. The study population would be all patients \>18 years of age undergoing TAVI procedure and who agree to participate in the study in 8 centers in Barcelona.
Eligibility 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.
Frequently Asked Questions
Who can join the NCT07059728 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Stenosis Treated With TAVI. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07059728 currently recruiting?
Yes, NCT07059728 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hospital Clinic of Barcelona to inquire about joining.
Where is the NCT07059728 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT07059728 clinical trial?
NCT07059728 is sponsored by Hospital Clinic of Barcelona. The trial plans to enroll 452 participants.