About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Transfemoral TAVR elective procedure
Age >18 years
Disqualifiers
Patients under 18 years of age
Refusal to participate
Known allergy to propofol or remifentanil.
Non-femoral surgical access.
Trial design
Parallel
Treatments tested in this trial
Oxygen therapy during sedation provided via high nasal cannulae (60L/min at 60% FiO2)
DeviceIntervention group: Oxygen therapy during sedation provided via high nasal cannulae (60L/min at 60% FiO2)
Oxygen therapy during sedation delivered via nasal cannulae at 5L/min
DeviceControl group: Oxygen therapy during sedation delivered via nasal cannulae at 5L/min
Treatment groups
Trial outcomes
Primary outcomes
Postoperative complications
Reduction in complications at 30 days post-procedure). Classic composite variable that includes: 30-day post-procedure mortality, need for hospital readmission due to acute heart failure, incidence of stroke, and incidence of acute kidney injury.
Win ratio
Win ratio analysis for outcomes: 30-day post-procedure mortality, need for hospital readmission for acute heart failure, incidence of acute stroke, incidence of acute kidney injury, and quality of life (measured by the Kansas Questionnaire)
Secondary outcomes
Number of Desaturation episodes
Pulse oximetry values inferior to 93% for a period of more than 10 seconds.
Desaturation incidence
Probability of presenting at least 1 episode of desaturation
PaO2
Arterial partial pressure oxygen
PaCO2
CO2 arterial partial pressure
Sponsors and contacts
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