An interventional study of High flow nasal oxygen in Aortic Stenosis and Sedation Complication, sponsored by Hospital Clinic of Barcelona. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by Hospital Clinic of Barcelona · Not applicable, Interventional, and Treatment
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.
1,006 studies on the registry are indexed under Aortic Valve Stenosis; 284 are open to participants now.
This study's enrollment of 132 is close to the median of 120 across 537 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Hospital Clinic of Barcelona is the lead sponsor of 326 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
In the intervention group, 50 L/min with 0.6 FiO2 will be administered through a high-flow nasal cannula.
Device: High flow nasal oxygen
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
Use of High-flow nasal oxygen at 60% 50 L/min.
The number of oxygen desaturation episodes
An oxygen desaturation episode is defined as any episode of Sp02 \<93% more than 10 seconds
Time frame: up to 24 hours
The number of patients with at least 1 desaturation episode
An oxygen desaturation episode is defined as any episode of Sp02 \<93% more than 10 seconds
Time frame: up to 24 hours
Hypoxia
PO2
Time frame: At placing the arterial catheter moment (baseline), and 45 minutes after the start of sedation
Hipercapnia
PaCO2
Time frame: At placing the arterial catheter moment (baseline), and 45 minutes after the start of sedation
Trends in plasmatic enolase neurospecific
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.
Trends in plasmatic Biomarkers of kidney injury
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.
Trends in plasmatic Biomarkers of myocardial injury
Study of plasmatic biomarkers of ischaemic damage in myocardium with troponin and pro-BNP
Time frame: the day before the procedure (baseline), 45 minutes, and 8 hours after the start of sedation.
Respiratory depression
Number of respiratory depression episodes requiring manual ventilation.
Time frame: During the TAVI procedure
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2023 to primary completion in Jul 2024, 8 months.
Of 174 non-industry interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 79. This study's 8 months is below that.
Counting every sponsor, half of 277 studies reached it within 33 months; a quarter within 19 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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