An interventional study of Oxygen therapy during sedation provided via high nasal cannulae (60L/min at 60% FiO2) and Oxygen therapy during sedation delivered via nasal cannulae at 5L/min in Aortic Stenosis Treated With TAVI and Sedation; Aged; Hemodynamics, sponsored by Hospital Clinic of Barcelona. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Hospital Clinic of Barcelona · Not applicable, Interventional, and Supportive care
Among 82 studies in Aortic Valve Stenosis with a site in Spain — 24 open to participants now, 31 under way, 1 of them phase 3. Aortic Valve Stenosis · Spain.
Among the 82 studies in Aortic Valve Stenosis with a site in Spain, this one is the 13th largest by planned enrollment of the 36 interventional ones that give a count, is the only one that started in 2027, is one of 25 with no phase, reaches primary completion later than 23 of the 30 other live ones, and was the 78th registered.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 452 is above the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →24 of the 82 studies in Aortic Valve Stenosis with a site in Spain are open now.
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 209 Aortic Valve Stenosis studies recruiting now, 163 (78%) set no upper age limit and 9 (4%) stop at 75 or younger; 25 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →82 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 2 · Phase 3 3 · Phase 4 7
First in 2006; this study’s year is marked. 1 started in 2027.
Median enrollment 208 across the 36 interventional studies, 373 across the 46 observational. Of the 42 that completed or were terminated, 9 (21%) have results posted.
36 of 82 have an industry lead sponsor. The 10 most frequent:
Hospital Clinic of Barcelona is the lead sponsor of 327 studies on the registry; 55 are open to participants now.
Hospital Clinic of Barcelona has 4 studies filed under Aortic Valve Stenosis — fewer than ten, so there is no comparison to draw.
5 of the studies in Aortic Valve Stenosis with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05758909Fundación EPICEvaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation | 2026-12-01 |
| NCT06833762Hospital Clinic of BarcelonaClinical and CPET Parameters That Predict Improvement in Functional Capacity After TAVI | 2027-06 |
| NCT05283356Fundacin Biomedica Galicia SurSingle Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation | 2027-06-30 |
| NCT06008080Abbott Medical DevicesPost-Market Clinical Follow Up Study With Navitor Valve | 2027-07 |
| NCT06049654Fundación EPICComparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication | 2027-11-01 |
Among the 82 studies in Aortic Valve Stenosis with a site in Spain, from their registry updates:
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.
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. These technological advances have enabled a minimally invasive anesthetic approach that avoids mechanical ventilation, central line insertion, and urinary catheterization in most patients undergoing TAVR.
However, patients selected for this procedure often have a profile associated with multiple comorbidities such as pulmonary disease, ischemic coronary artery disease, and atherosclerosis of the carotid and renal arteries, which predispose them to certain complications.
Acute kidney injury (4%-35%), ischemic stroke (1%-3%), acute heart failure (7%-24%), and hypoxemia with hypercapnia are the most common perioperative complications. The overall 30-day mortality rate is 2.2%.
Because they are considered high-risk (both due to the procedure and the type of patient undergoing this procedure) and due to their duration, TAVI procedures were initially performed under general anesthesia. With improved procedure times and improved anesthetic techniques, the trend is to attempt to perform these procedures under deep sedation. As in many settings, sedation for diagnostic and/or therapeutic procedures can be achieved with a variety of medications, the goal of which is sedation to enable procedural success. The development and advancement of procedures as an alternative to surgery and/or more invasive diagnostic and therapeutic procedures means that the use of less invasive techniques is becoming increasingly common. Depending on the procedure, sedation may be required. However, despite the less invasive nature of these tests, deep sedation is frequently required for these procedures.
Deep sedation techniques have developed alongside technological advances that enable the provision of complex diagnostic and therapeutic procedures, often performed in settings outside the operating room. These settings include procedure rooms, radiology departments, outpatient departments, emergency rooms, surgical facilities, interventional cardiology departments, and so on. Deep sedation is used to support and enable the performance of these procedures. Enthusiasm for providing sedation for these procedures in a non-OR setting was tempered by an increase in mortality in non-OR areas, even leading one author to describe this as the "Wild West" of surgical and anesthetic practice. This required both professionals and regulatory authorities have developed increased oversight to improve the quality of care for out-of-the-operative procedures.
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 patients at risk due to obesity, sleep apnea, elevated ASA classification, age >60 years, and combined cardiorespiratory disease. The reported incidence of hypoxia ranges from 10% to 70%, depending on the definition of hypoxia used. The risk of hypoxia further increases with the duration of the procedure.
The risk of periprocedural hypoxia can be reduced by monitoring respiratory and sedation parameters. However, even the most effective monitoring and standards of care may not be sufficient to reverse the respiratory compromise caused by deep sedation. Deep sedation affects the respiratory system through effects on normal cardiorespiratory physiology. These changes include a drop in respiratory rate, tidal volume, and changes in cardiorespiratory dynamics, and these effects are further affected by patient positioning. Subjects with cardiorespiratory diseases, such as pulmonary hypertension and chronic respiratory diseases, are particularly at risk for a critical decline in function.
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.
High-flow nasal oxygen therapy (HFNO), which is also unique in that it is humidified, was developed to provide flow rates of up to 70 L/min through specially adapted nasal cannulae and reliably delivers oxygen concentrations between 21% and 100%. Many operators are finding that combining deep planes of sedation with HFNC reduces the risk of periprocedural hypoxia. HFNC reduces the work of breathing, physiological dead space and provides an element of positive end-expiratory airway pressure.
HFNO has the potential to reduce procedural hypoxic events, procedural interruptions, and increase therapeutic success. However, although not all trials have concluded that HFNO improves safety compared to standard nasal oxygen therapy, the experience of most operators is positive.
The additional cost of HFNO may be a limiting factor for its use during procedural sedation, but it may be justified in high-risk procedures and patients with risk factors (already discussed), as it improves safety and quality of care. Deep sedation now allows complex diagnostic and therapeutic procedures to be performed outside the operating room in high-risk patients, but it is not without risk, and tools must be developed to mitigate the possibility of such risk.
For all the reasons stated above, TAVI constitutes a risky procedure, presenting a profile of patients undergoing this procedure that can also be considered high risk. The use of HFNC could be justified in this context and could improve the outcomes and safety of these procedures.
The use of HFNC during sedation for TAVI could increase oxygen content and minimize hypercapnia, which frequently occur. This may have two potential benefits: one in terms of facilitating patient tolerance to anesthetic sedation; and the other in optimizing oxygen delivery to organs such as the brain, kidneys, and myocardium. Currently, the profile of patients typically proposed for TAVI is those with aortic disease and significant morbidity and/or older age, who have been ruled out for conventional surgery. These patients are more likely to develop periprocedural complications, being specially sensitive to them.
In a recent study conducted in the United Kingdom, the use of HFNO with a FiO2 of 30% was associated with an 18% reduction in desaturation episodes; however, a decrease in hypoxemia measured by arterial oxygen levels could not be observed.
In a recent randomized clinical trial conducted at the Hospital Clínic in Barcelona (currently under review), the use of HFNO with a FiO2 of 60% was associated with a 31% reduction in desaturation episodes, higher arterial oxygen levels, and improved postoperative renal function, both analytically (measured by creatinine and glomerular filtration rate) and clinically (a 10% reduction in the incidence of renal failure according to VARC criteria).
However, several questions remain to be determined. First, a potential impact (both clinical and analytical) on preventing damage to other target organs (brain and heart). Second, the identification of patient subgroups at higher risk of desaturation and hypoxemia during deep sedation and who, consequently, may benefit more from HFNC treatment. Finally, there is still no data to assess the clinical impact of HFNC on clinical variables such as mortality, hospital stay, and reduction of postoperative complications (stroke, delirium, heart failure, etc.).
The justification for the study would be the use of HFNC, a therapy already available in healthcare centers but not widely used for these procedures. The risks of its use are comparable to those of conventional nasal oxygen therapy. Potential benefits would include a reduction in respiratory complications, a potential improvement in organ-specific biomarker levels, and a potential reduction in clinical cardiological, neurological, and renal complications, as well as an improvement in hospital stay and periprocedural mortality.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients recieving high flow nasal oxygenation
Device: Oxygen therapy during sedation provided via high nasal cannulae (60L/min at 60% FiO2)
Patients recieving standard of care oxygen theraphy (5L/min via nasal cannulae)
Device: Oxygen therapy during sedation delivered via nasal cannulae at 5L/min
Intervention group: Oxygen therapy during sedation provided via high nasal cannulae (60L/min at 60% FiO2)
Control group: Oxygen therapy during sedation delivered via nasal cannulae at 5L/min
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
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
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
Desaturation incidence
Probability of presenting at least 1 episode of desaturation
Time frame: From enrollment until the end of TAVR procedure
PaO2
Arterial partial pressure oxygen
Time frame: At enrollment and at 45 minutes after enrollment
PaCO2
CO2 arterial partial pressure
Time frame: At enrollment and at 45 minutes after enrollment.
Neuronal Specific Enolase
Serological Neuronal Specific Enolase levels.
Time frame: At enrollment and at 8 hours after enrollment.
Creatinine
Creatinine serological levels
Time frame: At enrollment and at 8 hours after enrollment.
Troponin
Ultra-sensitive Troponin serological levels
Time frame: At enrollment and at 8 hours after enrollment.
NT-proBNP
NT-proBNP serological levels
Time frame: At enrollment and at 8 hours after enrollment.
Number of patients presenting with respiratory depression
Any desaturation episode that leads to patient's manual ventilation from responsible anesthesiologyst in order to mantain patients well being.
Time frame: From enrollment until the end of TAVR procedure
Vasopressors
Drugs used to mantain mean blood pressure levels above 65mmHg. Drug used and dose administered.
Time frame: From enrollment until the end of TAVR procedure.
Propofol and remifentanil
Drugs used to induce and mantain hypnosis. Total amount of propofol and remifentanil administered during the procedure
Time frame: From enrollment until the end of TAVR procedure
Procedural duration
Time of duration of sedation
Time frame: Procedure (Time from start of sedation to when sedation drugs are stopped)
Start is estimated for Jan 2027; primary completion for Jul 2028, 18 months later.
Of 177 non-industry interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 79. This study's planned 18 months is below that.
Counting every sponsor, half of 288 studies reached it within 33 months; a quarter within 18 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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