Skip to main content
OpenTrials
Completed

NCT Number: NCT04489914

Observational Study on the Application of High-Flow Therapy After Percutaneous Transfemoral 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Schleswig-Holstein

Lübeck, 23538, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • High-flow oxygen therapy after TAVI

Exclusion criteria

  • patients without consent
  • age < 18 years

Treatment and study plan

High-Flow Oxygen Therapy

Device

high-flow oxygen therapy after percutaneous transfemoral aortic valve replacement

Primary outcomes

  1. Change of Horovitz index

    Time frame: 24 hours

    The Gradient of paO2/FiO2 will be determined after TAVI via blood gas analysis

Sponsors and collaborators

Lead sponsor

Drägerwerk AG & Co. KGaA

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 28, 2020
Registry last updated
Aug 18, 2021

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.