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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarlsburg Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients after implantation of a durable left ventricular assist device

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Negative pressure ventilation

    Device

    All participants are ventilated with negative pressure ventilation first

  • positive pressure ventilation

    Device

    All participants are ventilated using positive pressure ventilation after negative pressure ventilation

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: All participants negative pressure ventilation and positive pressure ventilationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

RVSWI

right ventricular stroke work index

Time frame
one minute

Secondary outcomes

Other outcomes

Sponsors and contacts

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Karlsburg Hospital

Lead sponsor

University Hospital Freiburg

Collaborator