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NCT Number: NCT06572072

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Karlsburg, Klinik für Anästhesiologie

Karlsburg, Mecklenburg-Vorpommern, 17495, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients planned for tricuspidal clipping

Exclusion criteria

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

Treatment and study plan

Negative Pressure Ventilation

Device

Substitution of positive pressure ventilation by negative pressure ventilation

Primary outcomes

  1. stroke volume index

    Time frame: 1 minute

    transesophageal ultrasound measurement

Secondary outcomes

  1. RVEF

    Time frame: 1 minute

    transesophageal ultrasound measurement

  2. LVEF

    Time frame: 1 minute

    transesophageal ultrasound measurement

  3. volumes of chambers

    Time frame: 1 minute

    transesophageal ultrasound measurement

  4. strain

    Time frame: 1 minute

    transesophageal ultrasound measurement

  5. VC

    Time frame: 1 minute

    transesophageal ultrasound measurement

  6. PISA

    Time frame: 1 minute

    transesophageal ultrasound measurement

  7. EROA

    Time frame: 1 minute

    transesophageal ultrasound measurement

  8. area of regurgitation of tricuspid valve

    Time frame: 1 minute

    transesophageal ultrasound measurement

  9. arterial blood pressures

    Time frame: 1 minute

    hemodynamic measurements

  10. venous blood pressures

    Time frame: 1 minute

    hemodynamic measurements

  11. pulmonal blood pressures

    Time frame: 1 minute

    hemodynamic measurements

  12. heart frequency

    Time frame: 1 minute

    hemodynamic measurements

  13. tidal volume

    Time frame: 1 minute

    ventilatory measurements

  14. minute volume

    Time frame: 1 minute

    ventilatory measurements

  15. breathing rate

    Time frame: 1 minute

    ventilatory measurements

  16. etCO2

    Time frame: 1 minute

    ventilatory measurements

  17. pO2 in the blood

    Time frame: 1 minute

    blood gases

  18. pCO2 in the blood

    Time frame: 1 minute

    blood gases

  19. Laktat

    Time frame: 1 minute

    blood gases

  20. cerebral oximetry

    Time frame: 1 minute

    NIRS

Sponsors and collaborators

Lead sponsor

Karlsburg Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2024
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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