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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04489914
Enrollment
25
Registered
2020-07-28
Start date
2020-10-12
Completion date
2021-04-23
Last updated
2021-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transcatheter Aortic Valve Replacement

Brief 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.

Interventions

high-flow oxygen therapy after percutaneous transfemoral aortic valve replacement

Sponsors

Drägerwerk AG & Co. KGaA
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* High-flow oxygen therapy after TAVI

Exclusion criteria

* patients without consent * age \< 18 years

Design outcomes

Primary

MeasureTime frameDescription
Change of Horovitz index24 hoursThe Gradient of paO2/FiO2 will be determined after TAVI via blood gas analysis

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026