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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04489914
Other study ID # TAVI-STAR
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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