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

NCT07034599 | Recruiting

• 1 other identifier: KAIKB 2025-2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• RVSWI

  right ventricular stroke work index

  one minute

Study Arms (1)

All participants negative pressure ventilation and positive pressure ventilation

EXPERIMENTAL

Device: Negative pressure ventilation; Device: positive pressure ventilation

Interventions

Negative pressure ventilation DEVICE

All participants are ventilated with negative pressure ventilation first

All participants negative pressure ventilation and positive pressure ventilation

positive pressure ventilation DEVICE

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

All participants negative pressure ventilation and positive pressure ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients after implantation of a durable left ventricular assist device

You may not qualify if:

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

Sponsors & Collaborators

• Karlsburg Hospital: lead
• University Hospital Freiburg: collaborator

Study Sites (1)

Klinikum Karlsburg

Karlsburg, Germany

RECRUITING

MeSH Terms

Conditions

Critical Illness; Heart Failure

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Matthias Heringlake, Prof. Dr. med.

CONTACT

038355 70-2500; Heringlake@drguth.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department for anesthesiology and critical care

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: June 24, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2025-06

Locations

DE (1)