High Flow Nasal Oxygen Cannula in Transcatheter Aortic Valve Replacement: Complications and Biomarkers (HIGH-OXY-TAVR)

December 16, 2024 updated by: Hospital Clinic of Barcelona

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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
Use of High-flow nasal oxygen at 60% 50 L/min.
No Intervention: Control
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 24 hours
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
up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypoxia
Time Frame: At placing the arterial catheter moment (baseline), and 45 minutes after the start of sedation
PO2
At placing the arterial catheter moment (baseline), and 45 minutes after the start of sedation
Hipercapnia
Time Frame: At placing the arterial catheter moment (baseline), and 45 minutes after the start of sedation
PaCO2
At placing the arterial catheter moment (baseline), and 45 minutes after the start of sedation
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
the day before the procedure (baseline), 45 minutes, and 8 hours after the start of sedation.
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
the day before the procedure (baseline), 45 minutes, and 8 hours after the start of sedation.
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
the day before the procedure (baseline), 45 minutes, and 8 hours after the start of sedation.
Respiratory depression
Time Frame: During the TAVI procedure
Number of respiratory depression episodes requiring manual ventilation.
During the TAVI procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

July 1, 2024

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

June 29, 2023

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Actual)

July 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 16, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB/2022/1095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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