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Not yet recruiting NCT06572072

Effects of Negative Pressure Ventilation on Right Ventricular Function in Cardiological Patients

— Observational Negative Pressure Ventilation Right Ventricular Dysfunction Right Ventricular Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Negative Pressure Ventilation.
Who it may be relevant to
Registry conditions: Negative Pressure Ventilation, Right Ventricular Dysfunction, Right Ventricular Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of Negative Pressure Ventilation on Right Ventricular Function in Cardiological Patients With Reduced Right Ventricular Function.

Overview

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.

Interventions

  • Device Negative Pressure Ventilation
    Substitution of positive pressure ventilation by negative pressure ventilation

Primary outcome measures

  • stroke volume index [Time frame: 1 minute]
Secondary outcome measures (12)
  • RVEF [Time frame: 1 minute]
  • LVEF [Time frame: 1 minute]
  • volumes of chambers [Time frame: 1 minute]
  • strain [Time frame: 1 minute]
  • VC [Time frame: 1 minute]
  • PISA [Time frame: 1 minute]
  • EROA [Time frame: 1 minute]
  • area of regurgitation of tricuspid valve [Time frame: 1 minute]
  • arterial blood pressures [Time frame: 1 minute]
  • venous blood pressures [Time frame: 1 minute]
  • pulmonal blood pressures [Time frame: 1 minute]
  • heart frequency [Time frame: 1 minute]

Eligibility criteria

Inclusion criteria

  • patients planned for tricuspidal clipping

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Germany · 1 center
  • Klinikum Karlsburg, Klinik für Anästhesiologie — Karlsburg

Identifiers

NCT: NCT06572072 · KAIKB-2024_1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗