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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Clinic of Barcelona

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

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

    Device

    Intervention 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

    Device

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

Treatment groups

452 Participants
are divided into 2 treatment groups
Group A: HFNO groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to 30 days after intervention
2

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)

Time frame
From enrollment to 30 days after the intervention ends

Secondary outcomes

1

Number of Desaturation episodes

Pulse oximetry values inferior to 93% for a period of more than 10 seconds.

Time frame
From enrollment until end of TAVR procedure
2

Desaturation incidence

Probability of presenting at least 1 episode of desaturation

Time frame
From enrollment until the end of TAVR procedure
3

PaO2

Arterial partial pressure oxygen

Time frame
At enrollment and at 45 minutes after enrollment
4

PaCO2

CO2 arterial partial pressure

Time frame
At enrollment and at 45 minutes after enrollment.

Other outcomes

Sponsors and contacts

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