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

Not Applicable

Completed

• Conditions: Sedation Complication; Aortic Stenosis
• Interventions: Device: High flow nasal oxygen

• Registration Number: NCT05958537
• Lead Sponsor: Hospital Clinic of Barcelona

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-29
• Study First Submitted QC: 2023-07-20
• Study First Posted: 2023-07-24
• Study Start: 2023-11-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	High flow nasal oxygen	In the intervention group, 50 L/min with 0.6 FiO2 will be administered through a high-flow nasal cannula.

Primary Outcome Measures

Name	Time	Method
The number of oxygen desaturation episodes	up to 24 hours	An oxygen desaturation episode is defined as any episode of Sp02 \<93% more than 10 seconds
The number of patients with at least 1 desaturation episode	up to 24 hours	An oxygen desaturation episode is defined as any episode of Sp02 \<93% more than 10 seconds

Secondary Outcome Measures

Name	Time	Method
Hypoxia	At placing the arterial catheter moment (baseline), and 45 minutes after the start of sedation	PO2
Trends in plasmatic Biomarkers of myocardial injury	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
Hipercapnia	At placing the arterial catheter moment (baseline), and 45 minutes after the start of sedation	PaCO2
Trends in plasmatic enolase neurospecific	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
Respiratory depression	During the TAVI procedure	Number of respiratory depression episodes requiring manual ventilation.
Trends in plasmatic Biomarkers of kidney injury	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

Trial Locations

Locations (1)

Hospital Clínic Barcelona; 🇪🇸 Barcelona, Spain