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.
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
- 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
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.
- Conditions
- Pneumonia, Atelectasis, ARDS
- Medical subject headings
- Pneumonia, Pulmonary Atelectasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in right ventricular pressure and volume and derived functional parameters caused by positive endexspiratory pressure
Measured: 15 minutes at each PEEP-Level
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
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.
- First posted2 Feb 2023
- Study start4 Nov 2022
- Primary completion4 Nov 2024 (estimated)
- Study completion4 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Invasive Mechanical Ventilation on the Right Ventricular Function
- ClinicalTrials.gov ID
- NCT05710419
- Acronym / sponsor ID
- 157/22
- Conditions
- Pneumonia, Atelectasis, ARDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 4 Nov 2024 (estimated)
- Study completion
- 4 Nov 2024 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- No written consent
- contraindications for right heart catheterization or conductance catheterization
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in right ventricular pressure and volume and derived functional parameters caused by positive endexspiratory pressure
Time frame: 15 minutes at each PEEP-Level
Changes in right ventricular pressure and volume and derived functional parameters caused by prone positioning
Time frame: 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
Time frame: 10 minutes after start of NO-Administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.