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Not yet recruitingNCT06572072Updated Aug 26, 2024

Effects of Negative Pressure Ventilation on Right Ventricular Function in Cardiological Patients

An observational study in Negative Pressure Ventilation, Right Ventricular Dysfunction and Right Ventricular Failure, sponsored by Karlsburg Hospital. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-26.

Sponsored by Karlsburg Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

Patients receives induction of general anesthesia for interventional tricuspidal clipping and standard monitoring for this procedure including arterial and central venous line and transesophageal ultrasound. A cuirass for extrathoracal negative pressure ventilation is placed onto the chest but not switched on. During usual positive pressure ventilation a ventilatory, a hemodynamic and a 3D full volume ultrasounddataset of the right and left ventricle is recorded and severity of tricuspidal regurgitation examined. Afterwards negative pressure ventilation is started and positive pressure ventilation reduced as far as possible without reduction of tidal volumes. The same dataset of ventilation, hemodynamics and ultrasound is collected again during negative pressure ventilation. Afterwards the cuirass gets removed, study finished and everything proceeds as during standard procedure.

02

Conditions studied

  • Negative Pressure Ventilation
  • Right Ventricular Dysfunction
  • Right Ventricular Failure
03

In context

Ventricular Dysfunction, Right

90 studies on the registry are indexed under Ventricular Dysfunction, Right; 28 are open to participants now.

This study's planned enrollment of 30 is below the median of 100 across 51 observational studies indexed under Ventricular Dysfunction, Right.

Browse Ventricular Dysfunction, Right 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
Sampling method
Non-probability sample

Study population

All patients for tricuspidal clipping without an exclusion criterium

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients planned for tricuspidal clipping

Exclusion criteria

Exclusion Criteria:

  • ventilatory of hemodynamic instability
  • fitting of cuirass not possible
  • unavailability of examiner
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
30 participants (estimated)
Patient registry
No

Interventions

  • DeviceNegative Pressure Ventilation

    Substitution of positive pressure ventilation by negative pressure ventilation

06

What researchers measure

Primary outcomes

  1. stroke volume index

    transesophageal ultrasound measurement

    Time frame: 1 minute

Secondary outcomes

  1. RVEF

    transesophageal ultrasound measurement

    Time frame: 1 minute

  2. LVEF

    transesophageal ultrasound measurement

    Time frame: 1 minute

  3. volumes of chambers

    transesophageal ultrasound measurement

    Time frame: 1 minute

  4. strain

    transesophageal ultrasound measurement

    Time frame: 1 minute

  5. VC

    transesophageal ultrasound measurement

    Time frame: 1 minute

  6. PISA

    transesophageal ultrasound measurement

    Time frame: 1 minute

  7. EROA

    transesophageal ultrasound measurement

    Time frame: 1 minute

  8. area of regurgitation of tricuspid valve

    transesophageal ultrasound measurement

    Time frame: 1 minute

  9. arterial blood pressures

    hemodynamic measurements

    Time frame: 1 minute

  10. venous blood pressures

    hemodynamic measurements

    Time frame: 1 minute

  11. pulmonal blood pressures

    hemodynamic measurements

    Time frame: 1 minute

  12. heart frequency

    hemodynamic measurements

    Time frame: 1 minute

  13. tidal volume

    ventilatory measurements

    Time frame: 1 minute

  14. minute volume

    ventilatory measurements

    Time frame: 1 minute

  15. breathing rate

    ventilatory measurements

    Time frame: 1 minute

  16. etCO2

    ventilatory measurements

    Time frame: 1 minute

  17. pO2 in the blood

    blood gases

    Time frame: 1 minute

  18. pCO2 in the blood

    blood gases

    Time frame: 1 minute

  19. Laktat

    blood gases

    Time frame: 1 minute

  20. cerebral oximetry

    NIRS

    Time frame: 1 minute

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

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 Aug 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06572072
Lead sponsor
Karlsburg Hospital
Responsible party
Prof. Dr. Matthias Heringlake (Principal Investigator, Karlsburg Hospital) — Principal investigator
First posted
Aug 26, 2024
Start date
Sep 1, 2024 (estimated)
Primary completion
Sep 1, 2025 (estimated)
Completion
Sep 1, 2025 (estimated)
Last update
Aug 26, 2024

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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