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

Transcatheter Aortic Valve Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04489914
• Other study ID #: TAVI-STAR
• Status: Completed
• Start date: October 12, 2020
• Est. completion date: April 23, 2021

Study information

• Verified date: August 2021
• Source: Drägerwerk AG & Co. KGaA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 23, 2021
• Est. primary completion date: April 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• High-flow oxygen therapy after TAVI

Exclusion Criteria:

• patients without consent

• age < 18 years

Related Conditions & MeSH terms

• Transcatheter Aortic Valve Replacement

Intervention

Device:
• High-Flow Oxygen Therapy
high-flow oxygen therapy after percutaneous transfemoral aortic valve replacement

Locations

Country	Name	City	State
Germany	University Schleswig-Holstein	Lübeck

Sponsors (1)

Lead Sponsor	Collaborator
Drägerwerk AG & Co. KGaA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Horovitz index	The Gradient of paO2/FiO2 will be determined after TAVI via blood gas analysis	24 hours