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

• Sponsor: Drägerwerk AG & Co. KGaA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04489914
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Actual Duration (Months): 6.3
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transcatheter Aortic Valve Replacement	Device: High-Flow Oxygen Therapy

Study Design

• Study Type: Observational
• Actual Enrollment: 25 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Oct 12, 2020
• Actual Primary Completion Date: Apr 23, 2021
• Actual Study Completion Date: Apr 23, 2021

Outcome Measures

Primary Outcome Measures

1. Change of Horovitz index [24 hours]

   The Gradient of paO2/FiO2 will be determined after TAVI via blood gas analysis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• High-flow oxygen therapy after TAVI

Exclusion Criteria:

• patients without consent

• age < 18 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Schleswig-Holstein	Lübeck		Germany	23538

Sponsors and Collaborators

• Drägerwerk AG & Co. KGaA

Investigators

• Principal Investigator: Tobias Graf, Dr, University Hospital Schleswig-Holstein

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Drägerwerk AG & Co. KGaA
• ClinicalTrials.gov Identifier: NCT04489914
• Other Study ID Numbers: TAVI-STAR
• First Posted: Jul 28, 2020
• Last Update Posted: Aug 18, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 18, 2021