Preventing Hypoxia in Sedated TAVI: SuperNO₂VA vs. Conventional Oxygen

NCT07006064 | Recruiting FDA Device

• 2 other identifiers: Ankara Bilkent City HospitalMuhammed Talha
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Stenosis

Keywords

aortic stenosis; Transcatheter Aortic Valve Implantation (TAVI); hypoxia; SuperNO 2 VA™ mask; end-tidal CO2

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Hypoxia (SpO₂ < 90% for >10 Seconds)

  Each patient included in the study will be monitored noninvasively with a pulse oximeter for oxygen saturation when taken to the operating room. The pulse oximeter will be placed on the index finger of the right hand. Oxygen saturation will be recorded as a numerical value between 0-100. Values below 90 will be evaluated as hypoxia and intervention will be made. Values below 90 will be evaluated as hypoxia and appropriate intervention will be made. A drop in SpO₂ below 90% lasting longer than 10 seconds will be recorded as hypoxia.

  12 hours

Secondary Outcomes (5)

• Number of Participants with Hypotension (MAP < 65 mmHg

  12 hours

• Number of Participants with Hypoxemia (PaO2 < 60 mmHg)

  12 hours

• Number of Participants with Hypercapnia or Hypocapnia (PaCO2 > 45 or < 35 mmHg)

  12 hours

• Mean and Abnormal EtCO2 Levels During Sedation (EtCO2 < 30 or > 50 mmHg)

  12 hours

• Number of Participants Experiencing Intraoperative Complications (Intubation, Resuscitation, or Bronchospasm)

  12 hours

Study Arms (2)

SUPERNOVA MASK

ACTIVE COMPARATOR

Device: SUPERNOVA

NASAL MASK

ACTIVE COMPARATOR

Device: NASAL MASK

Interventions

SUPERNOVA DEVICE

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.

SUPERNOVA MASK

NASAL MASK DEVICE

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

NASAL MASK

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of prolonged intubation
• History of tracheostomy
• Patients who are planned to undergo endotracheal intubation during the procedure
• Patients undergoing TAVI under local anesthesia

Sponsors & Collaborators

• Ankara Bilkent Sehir Hastanesi: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Pedro, M. and Cataldo, S. (2020) Validation of Novel Completely Sealed Nasal Positive Airway Pressure Device: SuperNO 2 VA™ EtCO 2 Measurement and Pressure Test Performance. Open Journal of Anesthesiology, 10, 337-348. doi: 10.4236/ojanes.2020.1010030 .

  BACKGROUND

• Kalner A, Kuchler F, Kavallari E, Muller M, Seufferlein T, Walter BM. Efficiency and safety of nasal positive airway pressure systems during endoscopic procedures in high-risk patients: Endo-Breath study. Endosc Int Open. 2024 May 29;12(5):E704-E714. doi: 10.1055/a-2306-9144. eCollection 2024 May.

  PMID: 38812697 BACKGROUND

• Luzzi C, Orlov D, Foley K, Horlick E, Osten M, Cusimano RJ, Djaiani G. Choice of anesthesia technique is associated with earlier hospital discharge and reduced costs after transcatheter transfemoral aortic valve implantation. J Thorac Dis. 2024 Mar 29;16(3):1836-1842. doi: 10.21037/jtd-23-1739. Epub 2024 Mar 27.

  PMID: 38617787 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Aortic Valve Stenosis; Hypoxia

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Muhammed T Daşgın

CONTACT

+90 541 2098225; m.talhadasgin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation Doctor, Principal Investigator

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 5, 2025
• Study Start: May 15, 2025
• Primary Completion: January 25, 2026
• Study Completion: February 25, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)