Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07059728 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Jul 2026 → Jul 2028
See other at-risk trials from Hospital Clinic of Barcelona

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Jul 2026 to Jul 2028 Show 9 more changesShow less
    • Start date: Feb 1, 2025 to Jan 1, 2027
    • Trial status changed: Recruiting → Not Yet Recruiting
    • Study completion pushed from Jul 2027 to Dec 2028
    • Interventions: Oxygen therapy during sedation delivered via nasal cannulae at 5L/min (Device), Oxygen therapy during sedation provided via high nasal… to Oxygen therapy during sedation delivered via nasal cannulae at 5L/min (Device), Oxygen therapy during sedation provided via high nasal…
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 3 of 12 entries
    • Study description revised
    • Site details revised
    • Publications: details revised at 27 of 27 entries
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2025 to Feb 1, 2025
    • Site details revised
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07059728
Lead Sponsor Hospital Clinic of Barcelona
Conditions
(from sponsor)
Aortic Stenosis Treated With TAVI, Sedation; Aged; Hemodynamics
Related terms Aortic Valve Stenosis
Enrollment 452 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov