NCT06572072

Brief Summary

Patients receives induction of general anesthesia for interventional tricuspidal clipping and standard monitoring for this procedure including arterial and central venous line and transesophageal ultrasound. A cuirass for extrathoracal negative pressure ventilation is placed onto the chest but not switched on. During usual positive pressure ventilation a ventilatory, a hemodynamic and a 3D full volume ultrasounddataset of the right and left ventricle is recorded and severity of tricuspidal regurgitation examined. Afterwards negative pressure ventilation is started and positive pressure ventilation reduced as far as possible without reduction of tidal volumes. The same dataset of ventilation, hemodynamics and ultrasound is collected again during negative pressure ventilation. Afterwards the cuirass gets removed, study finished and everything proceeds as during standard procedure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

August 7, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

August 7, 2024

Last Update Submit

August 23, 2024

Conditions

Negative Pressure VentilationRight Ventricular DysfunctionRight Ventricular Failure

Outcome Measures

Primary Outcomes (1)

  • stroke volume index

    transesophageal ultrasound measurement

    1 minute

Secondary Outcomes (20)

  • RVEF

    1 minute

  • LVEF

    1 minute

  • volumes of chambers

    1 minute

  • strain

    1 minute

  • VC

    1 minute

  • +15 more secondary outcomes

Interventions

Negative Pressure VentilationDEVICE

Substitution of positive pressure ventilation by negative pressure ventilation

Eligibility Criteria

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

All patients for tricuspidal clipping without an exclusion criterium

You may qualify if:

  • patients planned for tricuspidal clipping

You may not qualify if:

  • ventilatory of hemodynamic instability
  • fitting of cuirass not possible
  • unavailability of examiner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Karlsburg, Klinik für Anästhesiologie

Karlsburg, Mecklenburg-Vorpommern, 17495, Germany

Location

MeSH Terms

Conditions

Ventricular Dysfunction, RightHeart Failure

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 7, 2024

First Posted

August 26, 2024

Study Start

September 1, 2024

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

August 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)