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

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: Transcatheter Aortic Valve Replacement
• Intervention / Treatment: Device: High-Flow Oxygen Therapy

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Drägerwerk AG & Co. KGaA
• Investigators: Principal Investigator: Tobias Graf, Dr, University Hospital Schleswig-Holstein

Study record dates

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