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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06572072
Enrollment
30
Registered
2024-08-26
Start date
2024-09-01
Completion date
2025-09-01
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Negative Pressure Ventilation, Right Ventricular Dysfunction, Right Ventricular Failure

Brief 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.

Interventions

Substitution of positive pressure ventilation by negative pressure ventilation

Sponsors

Karlsburg Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients planned for tricuspidal clipping

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
stroke volume index1 minutetransesophageal ultrasound measurement

Secondary

MeasureTime frameDescription
RVEF1 minutetransesophageal ultrasound measurement
LVEF1 minutetransesophageal ultrasound measurement
strain1 minutetransesophageal ultrasound measurement
VC1 minutetransesophageal ultrasound measurement
PISA1 minutetransesophageal ultrasound measurement
EROA1 minutetransesophageal ultrasound measurement
area of regurgitation of tricuspid valve1 minutetransesophageal ultrasound measurement
arterial blood pressures1 minutehemodynamic measurements
venous blood pressures1 minutehemodynamic measurements
volumes of chambers1 minutetransesophageal ultrasound measurement
heart frequency1 minutehemodynamic measurements
tidal volume1 minuteventilatory measurements
minute volume1 minuteventilatory measurements
breathing rate1 minuteventilatory measurements
etCO21 minuteventilatory measurements
pO2 in the blood1 minuteblood gases
pCO2 in the blood1 minuteblood gases
Laktat1 minuteblood gases
cerebral oximetry1 minuteNIRS
pulmonal blood pressures1 minutehemodynamic measurements

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026