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

NCT ID: NCT07034599

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-12-01

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.

Conditions

Critical Illness; Heart Failure; LVAD

Study Design

• Allocation Method: NA
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

All participants negative pressure ventilation and positive pressure ventilation

Group Type: EXPERIMENTAL

Negative pressure ventilation

Intervention Type: DEVICE

All participants are ventilated with negative pressure ventilation first

positive pressure ventilation

Intervention Type: DEVICE

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

Interventions

Negative pressure ventilation

All participants are ventilated with negative pressure ventilation first

Intervention Type: DEVICE

positive pressure ventilation

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karlsburg Hospital

OTHER

Sponsor Role: lead

University Hospital Freiburg

OTHER

Sponsor Role: collaborator

Responsible Party

Prof. Dr. Matthias Heringlake

Head of department for anesthesiology and critical care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Matthias Heringlake, Prof. Dr. med.

Role: CONTACT

Heringlake@drguth.de

038355 70-2500

Other Identifiers

KAIKB 2025-2

Identifier Type: -

Identifier Source: org_study_id