Negative-pressure versus positive-pressure breathing after LVAD implantation
Effects of Negative Pressure Ventilation Onto Hemodynamics and Right Ventricular Funktion in Patients After Implantation of a Left Ventricular Assist Device.
NA · Karlsburg Hospital · NCT07034599
The team will try a 15-minute period of extra-thoracic negative pressure ventilation versus standard positive-pressure ventilation in people right after durable LVAD implantation to see which better supports right ventricular function and hemodynamics.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karlsburg Hospital (other) |
| Locations | 1 site (Karlsburg) |
| Trial ID | NCT07034599 on ClinicalTrials.gov |
What this trial studies
Stable patients who have just received a durable left ventricular assist device and are monitored with a pulmonary artery catheter undergo two ventilation modes: 15 minutes of extra-thoracic negative pressure ventilation and usual intrathoracic positive-pressure ventilation. Hemodynamic parameters including right ventricular function, pulmonary artery pressures, and cardiac output are recorded via the pulmonary artery catheter and compared between the two modes. Patients with intraoperative complications, unstable circulation or ventilation, inability to fit the cuirass, or unavailable investigators are excluded. The protocol aims to determine immediate hemodynamic effects of changing intrathoracic pressure support in the early postoperative period.
Who should consider this trial
Good fit: Ideal candidates are adults who are hemodynamically stable after durable LVAD implantation, monitored with a pulmonary artery catheter, and able to tolerate the extra-thoracic cuirass device.
Not a fit: Patients who experienced surgical complications, remain hemodynamically or ventilator-unstable, cannot fit the cuirass, or are not LVAD recipients are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the approach could identify a ventilation method that reduces right ventricular strain and improves early hemodynamic stability after LVAD implantation.
How similar studies have performed: Negative pressure ventilation has been shown in prior small or historical studies to alter intrathoracic pressures and affect right-heart loading, but its specific application immediately after LVAD implantation is limited and relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Karlsburg
- Klinikum Karlsburg — Karlsburg, Germany (RECRUITING)
Study contacts
- Study coordinator: Matthias Heringlake, Prof. Dr. med.
- Email: Heringlake@drguth.de
- Phone: 038355 70-2500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Critical Illness, Heart Failure, LVAD