Observational Study on the Application of High-Flow Therapy After Percutaneous Transfemoral Aortic Valve Replacement

August 17, 2021 updated by: Drägerwerk AG & Co. KGaA

Observational Study on the Application of High-Flow Therapy in the Postinterventional Follow-up Care of Patients With Percutaneous Interventional Aortic Valve Replacement

Percutaneous catheter-assisted valve replacement in aortic position (TAVI) for patients with high perioperative risk has become a standard method in recent years. In addition to the detection of bleeding and cardiac rhythm complications, follow-up care is mainly focused on the monitoring of respiratory parameters after an operation under intubation anesthesia or deep analgosedation. In addition to normal oxygen therapy, non-invasive ventilation and, in case of weaning failure, renewed tracheal intubation in the first 24 h after TAVI have been considered. High flow oxygen therapy (HFOT) now provides a good opportunity to treat patients with a warmed and humidified air-oxygen mixture and to independently control the oxygen content in the inhaled air and the flow in the pharyngeal area.

The aim of the Study is to investigate the Change in oxygenation after high-flow oxygen therapy as a measure of weaning success in postinterventional patients after TAVI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

25

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

  • Germany
      • Lübeck, Germany, 23538
        • University Schleswig-Holstein

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

University hospital

Description

Inclusion Criteria:

  • High-flow oxygen therapy after TAVI

Exclusion Criteria:

  • patients without consent
  • age < 18 years

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Horovitz index
Time Frame: 24 hours
The Gradient of paO2/FiO2 will be determined after TAVI via blood gas analysis
24 hours

Collaborators and Investigators

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

Sponsor

Drägerwerk AG & Co. KGaA

Investigators

  • Principal Investigator: Tobias Graf, Dr, University Hospital Schleswig-Holstein

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)

October 12, 2020

Primary Completion (Actual)

April 23, 2021

Study Completion (Actual)

April 23, 2021

Study Registration Dates

First Submitted

July 24, 2020

First Submitted That Met QC Criteria

July 24, 2020

First Posted (Actual)

July 28, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • TAVI-STAR

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

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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