High Flow Nasal Oxygen Cannula in Transcatheter Aortic Valve Replacement: Complications and Biomarkers

Aortic Stenosis Clinical Trial

— TAVR-Highflow  

Official title:

Use of High Flow Nasal Oxygen Cannula in Transcatheter Aortic Valve Replacement Procedures. Impact on Respiratory Complications and Biomarkers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05958537
• Other study ID #: HCB/2022/1095
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: June 2023
• Source: Hospital Clinic of Barcelona
• Contact: Marc Trilla, MsC
• Phone: +34 93 227 54 00
• Email: mtrilla[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: September 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients >18 years of age undergoing transfemoral TAVR procedure under local anaesthesia and sedation consenting to participate in the study

Exclusion Criteria:

• <18 years and/or refusal to give informed consent for participation General anaesthesia required to perform complex cases of TAVR

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Sedation Complication

Intervention

Device:
• High flow nasal oxygen
Use of High-flow nasal oxygen at 60% 50 L/min.

Locations

Country	Name	City	State
Spain	Hospital Clínic Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of oxygen desaturation episodes.	An oxygen desaturation episode is defined as any episode of Sp02 <93% more than 10 seconds	up to 24 hours
Secondary	Hypoxia	PO2	At placing the arterial catheter moment (baseline), and 45 minutes after the start of sedation
Secondary	Hipercapnia	PaCO2	At placing the arterial catheter moment (baseline), and 45 minutes after the start of sedation
Secondary	Trends in plasmatic enolase neurospecific	Study of plasmatic biomarkers of ischaemic damage in brain with Enolase neurospecific	the day before the procedure (baseline), 45 minutes, and 8 hours after the start of sedation.
Secondary	Trends in plasmatic Biomarkers of kidney injury	Study of plasmatic biomarkers of ischaemic damage in kidney with creatinine	the day before the procedure (baseline), 45 minutes, and 8 hours after the start of sedation.
Secondary	Trends in plasmatic Biomarkers of myocardial injury	Study of plasmatic biomarkers of ischaemic damage in myocardium with troponin and pro-BNP	the day before the procedure (baseline), 45 minutes, and 8 hours after the start of sedation.
Secondary	Respiratory depression	Number of respiratory depression episodes requiring manual ventilation.	During the TAVI procedure