Effects of Invasive Mechanical Ventilation on the Right Ventricular Function

NCT05710419 | Unknown

• 1 other identifier: 157/22
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the influence of mechanical ventilation on the right ventricular (RV) function. The primary focus is on methods which are routinely used to improve gas exchange in ventilated patients (positive end expiratory pressure \[PEEP\], inhalation of NO, prone positioning). The main questions it aims to answer are:

• Effects of prone positioning, PEEP and inhalation of NO on RV-function
• Are there determinants (clinical, laboratory, demographic, echocardiographic) for the right ventricular response to the above? RV-Function will be assessed with right ventricular pressure-volume loops recorded with a conductance catheter at
• each PEEP-Level during titration of the best PEEP
• before and every 5 minutes (for max. 45 minutes) after rotation to prone position
• before and under continuous inhalation of NO (if required based on clinical grounds)

Conditions

Pneumonia; Atelectasis; ARDS

Outcome Measures

Primary Outcomes (3)

• Changes in right ventricular pressure and volume and derived functional parameters caused by positive endexspiratory pressure

  15 minutes at each PEEP-Level

• Changes in right ventricular pressure and volume and derived functional parameters caused by prone positioning

  1, 5, 10, 15, 20, 25, 35 and 45 minutes after rotation

• Changes in right ventricular pressure and volume and derived functional parameters caused inhalation of NO

  10 minutes after start of NO-Administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study poulation consists of patients which require invasive ventilation as a result of a pulmonary disease and have a clinical need for prone positioning.

You may qualify if:

• Age \> 18 years
• Invasive mechanical ventilation and clinical indication for prone positioning (e.g. ARDS)
• No contraindications for right heart catheterization or conductance catheterization
• The written consent of the patient or his legal guardian

You may not qualify if:

• No written consent
• contraindications for right heart catheterization or conductance catheterization
• Pregnancy or breastfeeding

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

Department of Internal Medicine, Justus Liebig University Giessen, Universities of Giessen and Marburg Lung Center (UGMLC), German Center for Lung Research (DZL)

Giessen, Hesse, 35392, Germany

RECRUITING

MeSH Terms

Conditions

Pneumonia; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Khodr Tello, MD

CONTACT

+49 064198556087; khodr.tello@med.uni-giessen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: February 2, 2023
• Study Start: November 4, 2022
• Primary Completion: November 4, 2024
• Study Completion: November 4, 2024
• Last Updated: February 2, 2023

Record last verified: 2023-01

Locations

DE (1)