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

August 23, 2024 updated by: Prof. Dr. Matthias Heringlake, Karlsburg Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Mecklenburg Vorpommern
      • Karlsburg, Mecklenburg Vorpommern, Germany, 17495
        • Klinikum Karlsburg, Klinik für Anästhesiologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients for tricuspidal clipping without an exclusion criterium

Description

Inclusion Criteria:

  • patients planned for tricuspidal clipping

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stroke volume index
Time Frame: 1 minute
transesophageal ultrasound measurement
1 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RVEF
Time Frame: 1 minute
transesophageal ultrasound measurement
1 minute
LVEF
Time Frame: 1 minute
transesophageal ultrasound measurement
1 minute
volumes of chambers
Time Frame: 1 minute
transesophageal ultrasound measurement
1 minute
strain
Time Frame: 1 minute
transesophageal ultrasound measurement
1 minute
VC
Time Frame: 1 minute
transesophageal ultrasound measurement
1 minute
PISA
Time Frame: 1 minute
transesophageal ultrasound measurement
1 minute
EROA
Time Frame: 1 minute
transesophageal ultrasound measurement
1 minute
area of regurgitation of tricuspid valve
Time Frame: 1 minute
transesophageal ultrasound measurement
1 minute
arterial blood pressures
Time Frame: 1 minute
hemodynamic measurements
1 minute
venous blood pressures
Time Frame: 1 minute
hemodynamic measurements
1 minute
pulmonal blood pressures
Time Frame: 1 minute
hemodynamic measurements
1 minute
heart frequency
Time Frame: 1 minute
hemodynamic measurements
1 minute
tidal volume
Time Frame: 1 minute
ventilatory measurements
1 minute
minute volume
Time Frame: 1 minute
ventilatory measurements
1 minute
breathing rate
Time Frame: 1 minute
ventilatory measurements
1 minute
etCO2
Time Frame: 1 minute
ventilatory measurements
1 minute
pO2 in the blood
Time Frame: 1 minute
blood gases
1 minute
pCO2 in the blood
Time Frame: 1 minute
blood gases
1 minute
Laktat
Time Frame: 1 minute
blood gases
1 minute
cerebral oximetry
Time Frame: 1 minute
NIRS
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karlsburg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 23, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAIKB-2024_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Right Ventricular Dysfunction

Clinical Trials on Negative Pressure Ventilation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe