Hospital Clínic Barcelona
Barcelona, 08036, Spain
NCT Number: NCT05958537
Background Transcatheter aortic valve replacement is a risky procedure, performed in patients that can also be considered at risk of developing complications. The use of HFNO could be justified in this context and could improve the results and safety of these procedures. The use of HFNO during sedation for TAVR could increase oxygen content and minimise hypercapnia, which occurs frequently. This may have 2 potential benefits: one in terms of facilitating the patient's tolerance to anaesthetic sedation; and the other to optimise oxygen delivery to organs such as the brain, kidneys, and myocardium.
Primary aim The number of oxygen desaturation episodes. An oxygen desaturation episode is defined as any episode of Sp02 <93% for more than 10 seconds.
Method A single-center prospective randomised controlled clinical trial with 132 individuals comparing the use of High Flow Nasal oxygen (intervention group) with the conventional standard of care oxygenation with nasal cannula standard oxygenation (control group) of patients undergoing sedation for transfemoral TAVR. The randomisation process will be carried out with a 1:1 assignment, using the RedCap Clínic tool for this purpose. Both groups will be treated at the same centre and by the same interventional cardiology and anaesthesia team. Sedation regime will be based on Target controlled infusion (TCI) with propofol and remifentanil. Local anaesthesia will be infiltrated by interventional cardiologist prior obtaining femoral vascular access. 50 L/min with 0.6% FiO2 will be administered through a high-flow nasal cannula in the intervention group. In the control group, oxygen therapy will also be administered in all cases, using the usual procedure: oxygen therapy through a conventional nasal cannula and at a flow of 5 L/min.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Barcelona, 08036, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of High-flow nasal oxygen at 60% 50 L/min.
Time frame: up to 24 hours
An oxygen desaturation episode is defined as any episode of Sp02 <93% more than 10 seconds
Time frame: up to 24 hours
An oxygen desaturation episode is defined as any episode of Sp02 <93% more than 10 seconds
Time frame: At placing the arterial catheter moment (baseline), and 45 minutes after the start of sedation
PO2
Time frame: At placing the arterial catheter moment (baseline), and 45 minutes after the start of sedation
PaCO2
Time frame: the day before the procedure (baseline), 45 minutes, and 8 hours after the start of sedation.
Study of plasmatic biomarkers of ischaemic damage in brain with Enolase neurospecific
Time frame: the day before the procedure (baseline), 45 minutes, and 8 hours after the start of sedation.
Study of plasmatic biomarkers of ischaemic damage in kidney with creatinine
Time frame: the day before the procedure (baseline), 45 minutes, and 8 hours after the start of sedation.
Study of plasmatic biomarkers of ischaemic damage in myocardium with troponin and pro-BNP
Time frame: During the TAVI procedure
Number of respiratory depression episodes requiring manual ventilation.
Hospital Clinic of Barcelona
Other
Use of High Flow Nasal Oxygen Cannula in Transcatheter Aortic Valve Replacement Procedures. Impact on Respiratory Complications and Biomarkers
Acronym: HIGH-OXY-TAVR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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