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High Flow Nasal Oxygenation in Transcatheter Aortic Valve Replacement Procedures. TAVR-Highflow II

NCT07059728 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2025-09-15

No results posted yet for this study

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.

Conditions

  • Aortic Stenosis Treated With TAVI
  • Sedation; Aged; Hemodynamics

Interventions

DEVICE

Oxygen therapy during sedation provided via high nasal cannulae (60L/min at 60% FiO2)

Intervention group: Oxygen therapy during sedation provided via high nasal cannulae (60L/min at 60% FiO2)

DEVICE

Oxygen therapy during sedation delivered via nasal cannulae at 5L/min

Control group: Oxygen therapy during sedation delivered via nasal cannulae at 5L/min

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2026-07-31
Completion
2027-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07059728 on ClinicalTrials.gov