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

NCT ID: NCT04489914

Last Updated: 2021-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-12

Study Completion Date

2021-04-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Transcatheter Aortic Valve Replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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High-Flow Oxygen Therapy

high-flow oxygen therapy after percutaneous transfemoral aortic valve replacement

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* High-flow oxygen therapy after TAVI

Exclusion Criteria

* patients without consent
* age \< 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Drägerwerk AG & Co. KGaA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tobias Graf, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital Schleswig-Holstein

Locations

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University Schleswig-Holstein

Lübeck, , Germany

Site Status

Countries

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Germany

Other Identifiers

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TAVI-STAR

Identifier Type: -

Identifier Source: org_study_id

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