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

NCT ID: NCT06572072

Last Updated: 2024-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-09-01

Brief Summary

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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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Detailed Description

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Conditions

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Negative Pressure Ventilation Right Ventricular Dysfunction Right Ventricular Failure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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Negative Pressure Ventilation

Substitution of positive pressure ventilation by negative pressure ventilation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients planned for tricuspidal clipping

Exclusion Criteria

* ventilatory of hemodynamic instability
* fitting of cuirass not possible
* unavailability of examiner
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karlsburg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Matthias Heringlake

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Klinikum Karlsburg, Klinik für Anästhesiologie

Karlsburg, Mecklenburg-Vorpommern, Germany

Site Status

Countries

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Germany

Other Identifiers

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KAIKB-2024_1

Identifier Type: -

Identifier Source: org_study_id

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