High Flow Nasal Oxygenation in Transcatheter Aortic Valve Replacement Procedures. TAVR-Highflow II
NCT ID: NCT07059728
Last Updated: 2025-09-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
452 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-02-01
Study Completion Date
2027-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
High Flow Nasal Oxygen Cannula in Transcatheter Aortic Valve Replacement: Complications and Biomarkers
NCT05958537
Aortic Stenosis
Sedation Complication
COMPLETED
NA
Observational Study on the Application of High-Flow Therapy After Percutaneous Transfemoral Aortic Valve Replacement
NCT04489914
Transcatheter Aortic Valve Replacement
COMPLETED
A Prospective, Multicenter, Observational Study of the Safety and Efficacy of Emergency Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis
NCT07108478
Severe Aortic Valve Stenosis
NOT_YET_RECRUITING
Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients With Prohibitive Surgical Risk.
NCT05886517
Aortic Stenosis
RECRUITING
NA
Sedation or General Anesthesia During TAVR
NCT04347603
Stenoses, Aortic
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Aortic Stenosis Treated With TAVI
Sedation; Aged; Hemodynamics
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HFNO group
Patients recieving high flow nasal oxygenation
Group Type
EXPERIMENTAL
Oxygen therapy during sedation provided via high nasal cannulae (60L/min at 60% FiO2)
Intervention Type
DEVICE
Intervention group: Oxygen therapy during sedation provided via high nasal cannulae (60L/min at 60% FiO2)
Control group
Patients recieving standard of care oxygen theraphy (5L/min via nasal cannulae)
Group Type
ACTIVE_COMPARATOR
Oxygen therapy during sedation delivered via nasal cannulae at 5L/min
Intervention Type
DEVICE
Control group: Oxygen therapy during sedation delivered via nasal cannulae at 5L/min
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
Intervention Type
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
Intervention Type
DEVICE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Transfemoral TAVR elective procedure
* Age \>18 years
* Age \>18 years
Exclusion Criteria
* Patients under 18 years of age
* Refusal to participate
* Known allergy to propofol or remifentanil.
* Non-femoral surgical access.
* Presence of a basal skull fracture or pneumothorax
* Procedure duration \< 45 minutes
* Previously planned general anaesthesia approach due to patient's condition or procedural technical reasons
* Need to convert to general anesthesia for non-respiratory complications within 45 minutes.
* Refusal to participate
* Known allergy to propofol or remifentanil.
* Non-femoral surgical access.
* Presence of a basal skull fracture or pneumothorax
* Procedure duration \< 45 minutes
* Previously planned general anaesthesia approach due to patient's condition or procedural technical reasons
* Need to convert to general anesthesia for non-respiratory complications within 45 minutes.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Clinic of Barcelona
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Spain
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Scheuermann S, Tan A, Govender P, Mckie M, Pack J, Martinez G, Falter F, George S, A Klein A. High-flow nasal oxygen vs. standard oxygen therapy for patients undergoing transcatheter aortic valve replacement with conscious sedation: a randomised controlled trial. Perioper Med (Lond). 2023 Apr 14;12(1):11. doi: 10.1186/s13741-023-00300-8.
Reference Type
BACKGROUND
Turnbull D. High-flow nasal oxygen, procedural sedation, and clinical governance. Minerva Anestesiol. 2022 May;88(5):407-410. doi: 10.23736/S0375-9393.21.16078-X. Epub 2021 Sep 16.
Reference Type
BACKGROUND
Riddell Z, Pressler N, Siau K, Mulder CJJ, Shalmani HM, Downs A, Gait A, Ishaq S. Feasibility of high-flow nasal oxygen therapy and two-stage sedation during endoscopic hypopharyngeal therapy. JGH Open. 2020 May 16;4(4):743-748. doi: 10.1002/jgh3.12348. eCollection 2020 Aug.
Reference Type
BACKGROUND
Riccio CA, Sarmiento S, Minhajuddin A, Nasir D, Fox AA. High-flow versus standard nasal cannula in morbidly obese patients during colonoscopy: A prospective, randomized clinical trial. J Clin Anesth. 2019 May;54:19-24. doi: 10.1016/j.jclinane.2018.10.026. Epub 2018 Nov 2.
Reference Type
BACKGROUND
Kim SH, Bang S, Lee KY, Park SW, Park JY, Lee HS, Oh H, Oh YJ. Comparison of high flow nasal oxygen and conventional nasal cannula during gastrointestinal endoscopic sedation in the prone position: a randomized trial. Can J Anaesth. 2021 Apr;68(4):460-466. doi: 10.1007/s12630-020-01883-2. Epub 2021 Jan 6.
Reference Type
BACKGROUND
Sago T, Harano N, Chogyoji Y, Nunomaki M, Shiiba S, Watanabe S. A nasal high-flow system prevents hypoxia in dental patients under intravenous sedation. J Oral Maxillofac Surg. 2015 Jun;73(6):1058-64. doi: 10.1016/j.joms.2014.12.020. Epub 2014 Dec 30.
Reference Type
BACKGROUND
Lin Y, Zhang X, Li L, Wei M, Zhao B, Wang X, Pan Z, Tian J, Yu W, Su D. High-flow nasal cannula oxygen therapy and hypoxia during gastroscopy with propofol sedation: a randomized multicenter clinical trial. Gastrointest Endosc. 2019 Oct;90(4):591-601. doi: 10.1016/j.gie.2019.06.033. Epub 2019 Jul 3.
Reference Type
BACKGROUND
Teng WN, Ting CK, Wang YT, Hou MC, Chang WK, Tsou MY, Chiang H, Lin CL. High-Flow Nasal Cannula and Mandibular Advancement Bite Block Decrease Hypoxic Events during Sedative Esophagogastroduodenoscopy: A Randomized Clinical Trial. Biomed Res Int. 2019 Jul 16;2019:4206795. doi: 10.1155/2019/4206795. eCollection 2019.
Reference Type
BACKGROUND
Ischaki E, Pantazopoulos I, Zakynthinos S. Nasal high flow therapy: a novel treatment rather than a more expensive oxygen device. Eur Respir Rev. 2017 Aug 9;26(145):170028. doi: 10.1183/16000617.0028-2017. Print 2017 Sep 30.
Reference Type
BACKGROUND
Wen Z, Wang W, Zhang H, Wu C, Ding J, Shen M. Is humidified better than non-humidified low-flow oxygen therapy? A systematic review and meta-analysis. J Adv Nurs. 2017 Nov;73(11):2522-2533. doi: 10.1111/jan.13323. Epub 2017 May 30.
Reference Type
BACKGROUND
Wagstaff TA, Soni N. Performance of six types of oxygen delivery devices at varying respiratory rates. Anaesthesia. 2007 May;62(5):492-503. doi: 10.1111/j.1365-2044.2007.05026.x.
Reference Type
BACKGROUND
Raman V, Raman V, Tobias JD. Dexmedetomidine and Pulmonary Hype- rtension: A Case Report and Review of the Literature. J Med Cases. 2013;4(7):481-484. doi:10.4021/jmc.v4i7.1279
Reference Type
BACKGROUND
Wang CY, Ling LC, Cardosa MS, Wong AK, Wong NW. Hypoxia during upper gastrointestinal endoscopy with and without sedation and the effect of pre-oxygenation on oxygen saturation. Anaesthesia. 2000 Jul;55(7):654-8. doi: 10.1046/j.1365-2044.2000.01520.x.
Reference Type
BACKGROUND
Bell JK, Laasch HU, Wilbraham L, England RE, Morris JA, Martin DF. Bispectral index monitoring for conscious sedation in intervention: better, safer, faster. Clin Radiol. 2004 Dec;59(12):1106-13. doi: 10.1016/j.crad.2004.04.008.
Reference Type
BACKGROUND
Saunders R, Struys MMRF, Pollock RF, Mestek M, Lightdale JR. Patient safety during procedural sedation using capnography monitoring: a systematic review and meta-analysis. BMJ Open. 2017 Jun 30;7(6):e013402. doi: 10.1136/bmjopen-2016-013402.
Reference Type
BACKGROUND
Qadeer MA, Rocio Lopez A, Dumot JA, Vargo JJ. Risk factors for hypoxemia during ambulatory gastrointestinal endoscopy in ASA I-II patients. Dig Dis Sci. 2009 May;54(5):1035-40. doi: 10.1007/s10620-008-0452-2. Epub 2008 Nov 12.
Reference Type
BACKGROUND
van Schaik EPC, Blankman P, Van Klei WA, Knape HJTA, Vaessen PHHB, Braithwaite SA, van Wolfswinkel L, Schellekens WM. Hypoxemia during procedural sedation in adult patients: a retrospective observational study. Can J Anaesth. 2021 Sep;68(9):1349-1357. doi: 10.1007/s12630-021-01992-6. Epub 2021 Apr 20.
Reference Type
BACKGROUND
Wax D. Regulatory issues in office-based surgery and anesthesia. Semi- nars in Anesthesia, Perioperative Medicine and Pain. 2006;25(1):25-31. doi:10.1053/J.SANE.2005.11.005
Reference Type
BACKGROUND
Quattrone MS. Is the physician office the wild, wild west of health care? J Ambul Care Manage. 2000 Apr;23(2):64-73. doi: 10.1097/00004479-200004000-00009.
Reference Type
BACKGROUND
Puijk RS, Ziedses des Plantes V, Nieuwenhuizen S, Ruarus AH, Vroomen LGPH, de Jong MC, Geboers B, Hoedemaker-Boon CJ, Thone-Passchier DH, Gercek CC, de Vries JJJ, van den Tol PMP, Scheffer HJ, Meijerink MR. Propofol Compared to Midazolam Sedation and to General Anesthesia for Percutaneous Microwave Ablation in Patients with Hepatic Malignancies: A Single-Center Comparative Analysis of Three Historical Cohorts. Cardiovasc Intervent Radiol. 2019 Nov;42(11):1597-1608. doi: 10.1007/s00270-019-02273-y. Epub 2019 Jun 26.
Reference Type
BACKGROUND
Horn P, Hellhammer K, Minier M, Stenzel MA, Veulemans V, Rassaf T, Luedike P, Pohl J, Balzer J, Zeus T, Kelm M, Westenfeld R. Deep sedation Vs. general anesthesia in 232 patients undergoing percutaneous mitral valve repair using the MitraClip(R) system. Catheter Cardiovasc Interv. 2017 Dec 1;90(7):1212-1219. doi: 10.1002/ccd.26884. Epub 2017 Jan 23.
Reference Type
BACKGROUND
Raffay V, Fišer Z, Samara E, et al. Challenges in procedural sedation and anal- gesia in the emergency department. Journal of Emergency and Critical Care Medicine. 2020;8:27-27. doi:10.21037/jeccm-19-212
Reference Type
BACKGROUND
Cote GA, Hovis RM, Ansstas MA, Waldbaum L, Azar RR, Early DS, Edmundowicz SA, Mullady DK, Jonnalagadda SS. Incidence of sedation-related complications with propofol use during advanced endoscopic procedures. Clin Gastroenterol Hepatol. 2010 Feb;8(2):137-42. doi: 10.1016/j.cgh.2009.07.008. Epub 2009 Jul 14.
Reference Type
BACKGROUND
Anwaruddin S, Desai ND, Vemulapalli S, Marquis-Gravel G, Li Z, Kosinski A, Reardon MJ. Evaluating Out-of-Hospital 30-Day Mortality After Transfemoral Transcatheter Aortic Valve Replacement: An STS/ACC TVT Analysis. JACC Cardiovasc Interv. 2021 Feb 8;14(3):261-274. doi: 10.1016/j.jcin.2020.10.027.
Reference Type
BACKGROUND
Jakulla RS, Gunta SP, Huded CP. Heart Failure after Aortic Valve Replacement: Incidence, Risk Factors, and Implications. J Clin Med. 2023 Sep 19;12(18):6048. doi: 10.3390/jcm12186048.
Reference Type
BACKGROUND
Shekhar S, Isogai T, Agrawal A, Kaw R, Mahalwar G, Krishnaswamy A, Puri R, Reed G, Mentias A, Kapadia S. Outcomes and Predictors of Stroke After Transcatheter Aortic Valve Replacement in the Cerebral Protection Device Era. J Am Heart Assoc. 2024 Aug 6;13(15):e034298. doi: 10.1161/JAHA.124.034298. Epub 2024 Aug 5.
Reference Type
BACKGROUND
Zaleska-Kociecka M, Dabrowski M, Stepinska J. Acute kidney injury after transcatheter aortic valve replacement in the elderly: outcomes and risk management. Clin Interv Aging. 2019 Jan 21;14:195-201. doi: 10.2147/CIA.S149916. eCollection 2019.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HCB/2025/0514
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Clinical and CPET Parameters That Predict Improvement in Functional Capacity After TAVI
NCT06833762
RECRUITING
Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis
NCT06589063
RECRUITING
The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement
NCT02287662
COMPLETED
NA
Transcatheter Aortic Valve Implantation in Western NORway
NCT04417829
COMPLETED
Observational Study to Collect Data of Patient Which Recieving a TAVI in TAVI Procedure
NCT07215143
NOT_YET_RECRUITING
Near INfrared Spectroscopy in Aortic valvE ReplacemenT
NCT01251328
COMPLETED
NA
HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON CANADA
NCT02159794
WITHDRAWN
NA
Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement
NCT01531374
COMPLETED
NA
VARC-TAVI VALVE IMPLANTATION)
NCT06177392
NOT_YET_RECRUITING
NA
General Anesthesia Versus Loco-Regional Anesthesia for Transcarotid Trancatheter Aortic Valve Replacement
NCT06870734
NOT_YET_RECRUITING
HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON
NCT02157142
COMPLETED
NA
Pressure Gradient vs. Flow Relationships in Patients With Symptomatic Valvular Aortic Stenosis
NCT05580237
COMPLETED
Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation
NCT05758909
ACTIVE_NOT_RECRUITING
The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry
NCT02394184
COMPLETED
HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve
NCT04888247
RECRUITING
NA
Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation
NCT01805739
RECRUITING
Alternative Access Approaches for Transcatheter Aortic Valve Replace (TAVR) in Inoperable Patients With Aortic Stenosis
NCT01787084
COMPLETED
Telematic Intervention for Reversing Frailty Among Older Patients with Aortic Stenosis Undergoing Transcatheter Aortic Valve Intervention. the TELE-FRAIL TAVI Clinical Trial
NCT06742970
NOT_YET_RECRUITING
NA
Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement
NCT04944667
COMPLETED
NA
Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI
NCT02781896
COMPLETED
NA
TAVR Without Predilatation
NCT04350658
UNKNOWN
Validation of Accurate Commissural Alignment During Transcatheter Aortic Valve Implantation
NCT05097183
UNKNOWN
Prospective Evaluation of the Quality of Life of Elderly Patients Undergoing Transfemoral Percutanous Aortic Valve Replacement (TAVI) for the Treatment of Severe Aortic Stenosis.
NCT05539937
RECRUITING
Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis
NCT03633383
UNKNOWN
The TransCatheter Valve and Vessels Trial
NCT03424941
COMPLETED
NA