NCT04489914

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

October 12, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2021

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

July 24, 2020

Last Update Submit

August 17, 2021

Conditions

Transcatheter Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

  • Change of Horovitz index

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

    24 hours

Interventions

High-Flow Oxygen TherapyDEVICE

high-flow oxygen therapy after percutaneous transfemoral aortic valve replacement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

University hospital

You may qualify if:

  • High-flow oxygen therapy after TAVI

You may not qualify if:

  • patients without consent
  • age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Schleswig-Holstein

Lübeck, 23538, Germany

Location

Study Officials

  • Tobias Graf, Dr

    University Hospital Schleswig-Holstein

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2020

First Posted

July 28, 2020

Study Start

October 12, 2020

Primary Completion

April 23, 2021

Study Completion

April 23, 2021

Last Updated

August 18, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)