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NCT06088966 Clinical Trial

Evaluation of Hemodynamic and Ventilatory Effects of Negative Pressure Ventilation

Cardiac Output, Low Clinical Trial

Official title:
Evaluation of Hemodynamic and Ventilatory Effects of Negative Pressure Ventilation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06088966
Other study ID # KAIKB-2023-2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2023
Est. completion date April 1, 2024

Study information
Verified date October 2023
Source Karlsburg Hospital
Contact Matthias Heringlake, Prof. Dr.
Phone 004938355700
Email anaesthesie.karlsburg@klinikumkarlsburg.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Investigation of the effects of negative pressure ventilation after cardiac surgery in adults onto performance of the left and right heart and the lungs.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date April 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - patients with pulmonary artery catheter after cardiac surgery Exclusion Criteria: - minimally invasive surgery - unstable conditions - bleeding - unability to fit cuirass

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Klinikum Karlsburg, Klinik für Anästhesiologie Karlsburg Mecklenburg Vorpommern

Sponsors (1)
Lead Sponsor Collaborator
Karlsburg Hospital

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Stroke Volume Index in ml/m2 1 hour
Secondary Heart rate in beats/min 1 hour
Secondary blood pressure in mm/Hg 1 hour
Secondary arterial oxygen saturation in % 1 hour
Secondary mixed venous oxygen saturation in % measured via pulmonary catheter 1 hour
Secondary right ventricular ejection fraction in % measured via pulmonary catheter 1 hour
Secondary end diastolic volume index in ml/m2 measured via pulmonary catheter 1 hour
Secondary Cardiac index in l/min/m2 measured via pulmonary catheter 1 hour
Secondary tricuspid annular plane systolic excursion in mm measured via transesophageal echocardiography 1 hour
Secondary right ventricular fractional area change in % measured via transesophageal echocardiography 1 hour
Secondary Vena contract of tricuspid valve in mm measured via transesophageal echocardiography 1 hour
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