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PneumoniaNCT05710419

Effects of Invasive Mechanical Ventilation on the Right Ventricular Function

An observational study of Pneumonia and Atelectasis, run by University of Giessen at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pneumonia, Atelectasis, ARDS
How many people
30 participants
Where
1 siteGermany
Study dates
4 Nov 2022to 4 Nov 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site, 1 recruiting
  • 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

    Khodr Tello, MD

    Recruiting

Other trials in Germany

About this study

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?
Read more

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)
Read the detailed description

Pressure-volume loop (PV-loop) analysis is the gold standard for the assessment of right ventricular properties and function in clinical research. PV-Loops can be generated in real-time by conductance catheterization, which allows a simultaneous acquisition of pressure and volume changes in high resolution. It is known that invasive mechanical ventilation, primarily through a change in intrathoracic pressure conditions, has a significant impact on the function of the right ventricle. However, the underlying mechanisms have not yet been investigated and understood in detail using the gold standard. Therefore, the aim of this observational study is to investigate the effects of invasive ventilation and ventilatory strategies to improve gas exchange (PEEP, prone position, inhaled NO) on the function of the right ventricle.

The physiology of mechanical ventilation is fundamentally different than spontaneous breathing: While in spontaneous breathing the air fills the lungs driven by a negative intrathoracic pressure, in mechanical ventilation air has to be "pumped" into the lungs, resulting in a positive intrathoracic pressure. These unphysiological intrathoracic pressure conditions lead to complex interactions between the respiratory and cardiovascular system, can stress the right ventricle and cause hemodynamic instability. In addition to the stress of mechanical ventilation per se, there are changes in the pulmonary vasculature in caused by the pulmonary disease itself. A maximum expression of such changes is the acute respiratory failure syndrome (ARDS), which requires a complex ventilation strategy and is associated with a high mortality rate. ARDS is always associated with a dysfunction of the pulmonary vessels (hypoxic vasoconstriction, pulmonary microthrombosis, derecruitment of ventilated areas) leading to increased right ventricular afterload. In contrast to the left ventricle, the right ventricle has only a small contractile reserve and is therefore more sensible to a higher afterload. This is why the right ventricle can be seen as the weakest link of the circulatory system in patients with ARDS. This is also reflected in the fact that the high lethality of ARDS is more associated to circulatory failure and less to hypoxemia. A ventilation strategy that ensures adequate gas exchange and at the same time causes as little additional stress as possible on the right heart would be optimal.

If the patient is eligible for the study according to the inclusion and exclusion criteria, an echocardiographic examination with 3D volumetric measurement of the right-sided heart cavities is performed. The conductance catheter will then be calibrated using this volumetric dataset. First, a conventional right heart catheterization is performed (conventional Swan-Ganz catheter), followed by the placement of the conductance catheter and the recording of a baseline. The "best PEEP" is then titrated by minimizing the "driving pressure" during volume-controlled ventilation as a descending sequence (from high PEEP to low PEEP). PV loops are recorded at each PEEP level. After determining the best PEEP level, the patient will be rotated to prone position. PV loops are recorded immediately after the rotation and within the following 45 minutes. The catheter is then removed. If the admixture of NO in the respiratory gas is indicated for medical reasons, the PV loops are recorded before and after the start of the admixture.

Medical subject headings
Pneumonia, Pulmonary Atelectasis

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 15 minutes at each PEEP-Level

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

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

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

    Measured: 10 minutes after start of NO-Administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2023
  2. Study start4 Nov 2022
  3. Primary completion4 Nov 2024 (estimated)
  4. Study completion4 Nov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05710419
Sponsor's protocol ID
157/22
Status last verified
Jan 2023
First submitted
3 Jan 2023
Last updated
2 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pneumonia and Atelectasis, run by University of Giessen at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Khodr Tello, MD (+49 064198556087, khodr.tello@med.uni-giessen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in right ventricular pressure and volume and derived functional parameters caused by positive endexspiratory pressure (time frame: 15 minutes at each PEEP-Level). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.

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