CClinicalTrials.gg
RecruitingNCT07034599NPV LVADUpdated Feb 18, 2026

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

An interventional study of Negative pressure ventilation and positive pressure ventilation in Critical Illness, Heart Failure and LVAD, sponsored by Karlsburg Hospital. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-18.

Sponsored by Karlsburg Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Critical Illness
  • Heart Failure
  • LVAD
03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's planned enrollment of 30 is below the median of 90 across 979 interventional studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Karlsburg Hospital is the lead sponsor of 4 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Complication during surgery like bleeding, emergency, inability to fit the cuirass, unavailability of an investigator, unstable condition regarding circulation or ventilation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    All participants negative pressure ventilation and positive pressure ventilation

    Device: Negative pressure ventilation · Device: positive pressure ventilation

Interventions

  • DeviceNegative pressure ventilation

    All participants are ventilated with negative pressure ventilation first

  • Devicepositive pressure ventilation

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

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What researchers measure

Primary outcomes

  1. RVSWI

    right ventricular stroke work index

    Time frame: one minute

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07034599
Lead sponsor
Karlsburg Hospital
Collaborators
University Hospital Freiburg
Responsible party
Prof. Dr. Matthias Heringlake (Head of department for anesthesiology and critical care, Karlsburg Hospital) — Principal investigator
First posted
Jun 24, 2025
Start date
Oct 1, 2025
Primary completion
Oct 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Feb 18, 2026

Study contacts

Matthias Heringlake, Prof. Dr. med.
Contact
Heringlake@drguth.de
038355 70-2500

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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