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

NCT05958537 | Completed

• 1 other identifier: HCB/2022/1095
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis; Sedation Complication

Outcome Measures

Primary Outcomes (2)

• 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

• 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

  up to 24 hours

Secondary Outcomes (6)

• Hypoxia

  At placing the arterial catheter moment (baseline), and 45 minutes after the start of sedation

• Hipercapnia

  At placing the arterial catheter moment (baseline), and 45 minutes after the start of sedation

• Trends in plasmatic enolase neurospecific

  the day before the procedure (baseline), 45 minutes, and 8 hours after the start of sedation.

• Trends in plasmatic Biomarkers of kidney injury

  the day before the procedure (baseline), 45 minutes, and 8 hours after the start of sedation.

• Trends in plasmatic Biomarkers of myocardial injury

  the day before the procedure (baseline), 45 minutes, and 8 hours after the start of sedation.

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

High flow nasal oxygen DEVICE

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic Barcelona

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 24, 2023
• Study Start: November 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: December 19, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)