Effects of Negative Pressure Ventilation Onto Hemodynamics and Right Ventricular Funktion in Patients After Implantation of a Left Ventricular Assist Device.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Negative pressure ventilation, positive pressure ventilation.
- Who it may be relevant to
- Registry conditions: Critical Illness, Heart Failure, LVAD. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Negative pressure ventilation
All participants are ventilated with negative pressure ventilation first - Device positive pressure ventilation
All participants are ventilated using positive pressure ventilation after negative pressure ventilation
Primary outcome measures
- RVSWI [Time frame: one minute]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Klinikum Karlsburg — Karlsburg
Identifiers
NCT: NCT07034599 · KAIKB 2025-2