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

Karlsburg Hospital

Status: Not yet enrolling

Conditions: LVAD; Critical Illness; Heart Failure

Treatments: Device: Negative pressure ventilation; Device: positive pressure ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT07034599

KAIKB 2025-2

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 1 patient group

All participants negative pressure ventilation and positive pressure ventilation

Experimental group

Treatment:

Device: positive pressure ventilation

Device: Negative pressure ventilation