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

NCT ID: NCT05958537

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-07-01

Brief Summary

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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

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Conditions

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Aortic Stenosis Sedation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

High flow nasal oxygen

Intervention Type DEVICE

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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High flow nasal oxygen

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Clínic Barcelona

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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HCB/2022/1095

Identifier Type: -

Identifier Source: org_study_id