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Clinical Trials/NCT07034599
NCT07034599
Recruiting
Not Applicable

Effects of Negative Pressure Ventilation Onto Hemodynamics and Right Ventricular Funktion in Patients After Implantation of a Left Ventricular Assist Device.

Karlsburg Hospital1 site in 1 country30 target enrollmentStarted: October 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Karlsburg Hospital
Enrollment
30
Locations
1
Primary Endpoint
RVSWI

Overview

Brief Summary

All patients undergoing an implantation of a durable left ventricular assist device and monitored by pulmonary artery catheter showing no adverse events after surgery are included in the study and ventilated for 15 minutes using extra thoracic negative pressure ventilation and usual intrathoracic positive pressure ventilation. Hemodynamics changes between both ventilation modes, especially focussing on right ventricular function and measured by a pulmonary artery catheter, are compared.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

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

Inclusion Criteria

  • All patients after implantation of a durable left ventricular assist device

Exclusion Criteria

  • Complication during surgery like bleeding, emergency, inability to fit the cuirass, unavailability of an investigator, unstable condition regarding circulation or ventilation

Arms & Interventions

All participants negative pressure ventilation and positive pressure ventilation

Experimental

Intervention: Negative pressure ventilation (Device)

All participants negative pressure ventilation and positive pressure ventilation

Experimental

Intervention: positive pressure ventilation (Device)

Outcomes

Primary Outcomes

RVSWI

Time Frame: one minute

right ventricular stroke work index

Secondary Outcomes

No secondary outcomes reported

Investigators

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

Prof. Dr. Matthias Heringlake

Head of department for anesthesiology and critical care

Karlsburg Hospital

Study Sites (1)

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