Preventing low oxygen during sedated TAVI using SuperNO2VA versus standard oxygen
Official title: Comparison of SuperNO₂VA™ Nasal Mask and Conventional Nasal Oxygen Therapy in Preventing Hypoxia During Sedation for TAVI Procedures in Geriatric Patients
Run by Ankara Bilkent Sehir Hastanesi · NCT07006064 · Data updated 2026-11-12
This will test whether the SuperNO2VA nasal mask prevents low oxygen and poor breathing better than standard oxygen for people 65 and older having TAVI under sedation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Ankara Bilkent Sehir Hastanesi Academic / other |
| Locations | 1 site (Ankara) |
| Status | Recruiting |
| Started | May 15, 2025 |
| Main results expected | January 25, 2026 |
| Study ends | February 25, 2026 |
| Registry record updated | August 29, 2025 |
| Trial ID | NCT07006064 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 65 or older who are scheduled for TAVI under sedation and are not expected to require endotracheal intubation.
✕Probably not a fit
Patients planned for general anesthesia with intubation, those with a tracheostomy or history of prolonged intubation, or patients undergoing TAVI with only local anesthesia are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Older patients scheduled for TAVI under sedation will receive either the SuperNO2VA nasal mask or conventional oxygen delivery, with continuous monitoring including end-tidal CO2 and pulse oximetry. The trial enrolls patients aged 65 and older and excludes those with prior prolonged intubation, tracheostomy, or planned endotracheal intubation. Investigators will compare rates of hypoxemia and episodes of hypoventilation detected by capnography and oxygenation measures between groups. The primary aim is earlier detection and prevention of sedative-related respiratory depression to improve procedural safety in this high-risk population.
Why it matters
Potential benefit: If successful, the SuperNO2VA approach could reduce episodes of hypoxia and undetected hypoventilation during sedated TAVI, lowering complications for older patients.
How similar studies have gone: Capnography and nasal positive-pressure support have improved detection and prevention of hypoventilation in other sedated procedures, but data specifically on SuperNO2VA use during TAVI are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 65 years and older who are scheduled for TAVI under sedation will be included in the study. Exclusion Criteria: * History of prolonged intubation * History of tracheostomy * Patients who are planned to undergo endotracheal intubation during the procedure * Patients undergoing TAVI under local anesthesia
Where it's running
-
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Muhammed T Daşgın
- Email: m.talhadasgin@gmail.com
- Phone: +90 541 2098225
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.