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Clinical Trials/NCT06572072
NCT06572072
Not yet recruiting
Not Applicable

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

Karlsburg Hospital1 site in 1 country30 target enrollmentStarted: September 1, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Karlsburg Hospital
Enrollment
30
Locations
1
Primary Endpoint
stroke volume index

Overview

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • patients planned for tricuspidal clipping

Exclusion Criteria

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

Outcomes

Primary Outcomes

stroke volume index

Time Frame: 1 minute

transesophageal ultrasound measurement

Secondary Outcomes

  • RVEF(1 minute)
  • strain(1 minute)
  • heart frequency(1 minute)
  • volumes of chambers(1 minute)
  • breathing rate(1 minute)
  • pO2 in the blood(1 minute)
  • pCO2 in the blood(1 minute)
  • PISA(1 minute)
  • EROA(1 minute)
  • area of regurgitation of tricuspid valve(1 minute)
  • arterial blood pressures(1 minute)
  • LVEF(1 minute)
  • pulmonal blood pressures(1 minute)
  • VC(1 minute)
  • venous blood pressures(1 minute)
  • tidal volume(1 minute)
  • etCO2(1 minute)
  • minute volume(1 minute)
  • Laktat(1 minute)
  • cerebral oximetry(1 minute)

Investigators

Sponsor
Karlsburg Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. Matthias Heringlake

Principal Investigator

Karlsburg Hospital

Study Sites (1)

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