Comparison of SuperNO₂VA™ Nasal Mask and Conventional Nasal Oxygen Therapy in Preventing Hypoxia During Sedation for TAVI Procedures in Geriatric Patients

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

With increasing life expectancy, the geriatric population continues to grow. According to the Turkish Statistical Institute (TÜİK), the average life expectancy in Turkey between 2021 and 2023 is 77.3 years. As the number of elderly surgical patients rises, optimizing anesthesia care is critical to reducing complications and improving clinical outcomes. In elderly patients with severe aortic stenosis, traditional surgical aortic valve replacement poses a high risk of complications. Consequently, Transcatheter Aortic Valve Implantation (TAVI) has emerged as a preferred, less invasive alternative. Due to technological advancements and shorter procedure durations, TAVI is increasingly performed under sedation rather than general anesthesia. However, sedation carries risks, including hypoxemia and hypoventilation, primarily due to sedative-induced respiratory depression. Pulse oximetry, the traditional monitoring method, measures only peripheral oxygen saturation and does not provide early detection of apnea or hypoventilation. Therefore, monitoring end-tidal carbon dioxide (EtCO₂) during sedation has gained importance. The American Society of Anesthesiologists (ASA) recommends EtCO₂ monitoring during sedation. However, obtaining accurate EtCO₂ values via nasal cannulas is technically challenging. Open sampling ports and high oxygen flow rates can cause dilution or loss of exhaled CO₂, resulting in inaccurate readings. The SuperNO₂VA™ nasal mask (Vyaire Medical, USA) addresses these limitations with an integrated CO₂ sampling port and the ability to provide positive airway pressure. This facilitates more accurate EtCO₂ monitoring and better ventilatory support compared to standard nasal cannulas. Prior studies have demonstrated that the SuperNO₂VA mask significantly reduces the risk and severity of hypoxia in high-risk patients during sedated endoscopic procedures. It prevents upper airway collapse and increases ventilated lung surface area, without causing clinically significant hypercapnia or CO₂ retention. This study aims to compare the incidence of hypoxia in patients aged 65 years and older undergoing TAVI under sedation using either the SuperNO₂VA nasal mask or a conventional nasal oxygen mask. Secondary outcomes include the evaluation of intraoperative hypercapnia or hypocapnia and the assessment of postoperative respiratory complications.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• Patients aged 65 years and older who are scheduled for TAVI under sedation will be included in the study.

Locations
Other Locations
Turkey
Ankara Bilkent City Hospital
RECRUITING
Ankara
Contact Information
Primary
Muhammed T Daşgın
m.talhadasgin@gmail.com
+90 541 2098225
Time Frame
Start Date: 2025-05-15
Estimated Completion Date: 2026-02-25
Participants
Target number of participants: 100
Treatments
Active_comparator: SUPERNOVA MASK
Active_comparator: NASAL MASK
Sponsors
Leads: Ankara Bilkent Sehir Hastanesi

This content was sourced from clinicaltrials.gov