Preventing Hypoxia in Sedated TAVI: SuperNO₂VA vs. Conventional Oxygen

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

May 15, 2025

Primary Completion Date

January 25, 2026

Study Completion Date

February 25, 2026

Conditions
Aortic Stenosis
Interventions
DEVICE

SUPERNOVA

In the intervention group, oxygen is delivered using the SuperNO2VA™ nasal positive airway pressure mask (Vyaire Medical, USA), which differs from conventional nasal oxygen delivery systems by providing continuous positive airway pressure (CPAP) through a sealed nasal interface. This mask also includes an integrated sampling port for accurate end tidal carbon dioxide (EtCO2) monitoring. The aim is to reduce the incidence of hypoxia and allow for better detection and prevention of hypo/hypercapnia during sedation in elderly patients undergoing TAVI without intubation. The use of positive pressure is intended to prevent upper airway collapse, maintain functional residual capacity, and improve gas exchange during sedation.

DEVICE

NASAL MASK

Traditional nasal cannulas only provide passive oxygen flow. End-tidal CO2 measurement is being conducted with Capnostream™ 35 Portable Respiratory Monitor.

Trial Locations (1)

Unknown

RECRUITING

Ankara Bilkent City Hospital, Ankara

All Listed Sponsors
lead

Ankara Bilkent Sehir Hastanesi

OTHER