Skip to main content
OpenTrials
Completed

NCT Number: NCT05958537

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínic Barcelona

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high flow nasal oxygen

Device

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

Primary outcomes

  1. The number of oxygen desaturation episodes

    Time frame: up to 24 hours

    An oxygen desaturation episode is defined as any episode of Sp02 <93% more than 10 seconds

  2. The number of patients with at least 1 desaturation episode

    Time frame: up to 24 hours

    An oxygen desaturation episode is defined as any episode of Sp02 <93% more than 10 seconds

Secondary outcomes

  1. Hypoxia

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

    PO2

  2. Hipercapnia

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

    PaCO2

  3. Trends in plasmatic 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 brain with Enolase neurospecific

  4. Trends in plasmatic Biomarkers of kidney injury

    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

  5. Trends in plasmatic Biomarkers of myocardial injury

    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

  6. Respiratory depression

    Time frame: During the TAVI procedure

    Number of respiratory depression episodes requiring manual ventilation.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Acronym: HIGH-OXY-TAVR

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 24, 2023
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.