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

Not yet recruiting

• Conditions: Right Ventricular Dysfunction; Negative Pressure Ventilation; Right Ventricular Failure

• Registration Number: NCT06572072
• Lead Sponsor: Karlsburg Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-07
• Study First Submitted QC: 2024-08-23
• Last Update Submitted: 2024-08-23
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26
• Study Start: 2024-09-01
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• patients planned for tricuspidal clipping

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
stroke volume index	1 minute	transesophageal ultrasound measurement

Secondary Outcome Measures

Name	Time	Method
RVEF	1 minute	transesophageal ultrasound measurement
strain	1 minute	transesophageal ultrasound measurement
heart frequency	1 minute	hemodynamic measurements
volumes of chambers	1 minute	transesophageal ultrasound measurement
breathing rate	1 minute	ventilatory measurements
pO2 in the blood	1 minute	blood gases
pCO2 in the blood	1 minute	blood gases
PISA	1 minute	transesophageal ultrasound measurement
EROA	1 minute	transesophageal ultrasound measurement
area of regurgitation of tricuspid valve	1 minute	transesophageal ultrasound measurement
arterial blood pressures	1 minute	hemodynamic measurements
cerebral oximetry	1 minute	NIRS
LVEF	1 minute	transesophageal ultrasound measurement
pulmonal blood pressures	1 minute	hemodynamic measurements
VC	1 minute	transesophageal ultrasound measurement
venous blood pressures	1 minute	hemodynamic measurements
tidal volume	1 minute	ventilatory measurements
etCO2	1 minute	ventilatory measurements
minute volume	1 minute	ventilatory measurements
Laktat	1 minute	blood gases

Trial Locations

Locations (1)

Klinikum Karlsburg, Klinik für Anästhesiologie; 🇩🇪 Karlsburg, Mecklenburg Vorpommern, Germany