Congenital Heart DiseasePhase 1/2ILOCONCT07193719
Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children
A Phase 1/2 study testing End-expiratory lung volume optimization maneuver with PEEP titration in people with Congenital Heart Disease and Cardiopulmonary Bypass, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver (LVOM) is beneficial in 1. study) children undergoing biventricular repair of their congenital heart disease (CHD) with cardiopulmonary bypass and 2. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Congenital Heart Disease, Cardiopulmonary Bypass, Cardiac Surgery
- What is being tested?
- End-expiratory lung volume optimization maneuver with PEEP titration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 5 Dec 2025to 20 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- congenital heart disease
- surgery with cardiopulmonary bypass
Who cannot join
- single ventricle physiology
- ECMO/VAD
- <36weeks of gestational age
- chronic lung disease
- Endotracheal tube leak > 15%
- lack of informed consent from parents.
Show all 10Show fewer
- ECMO study Inclusion Criteria
- patients with respiratory failure on ECMO or at risk for ECMO
- invasive ventilation
- severe lung hypoplasia or interstitial lung disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Unviersity of Tuebingen, PICU
Tübingen, 72076
Jan C Clausen, MD, jan.clausen@posteo.de
About this study
Official title: Influence of a Personalized Lung Volume Optimization Maneuver on Lung Aeration and Cardiac Performance in Mechanically Ventilated Children
The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver (LVOM) is beneficial in
- study) children undergoing biventricular repair of their congenital heart disease (CHD) with cardiopulmonary bypass and
- study) in children with severe respiratory failure at risk for or need for ECMO.
Read more
The main questions it aims to answer are:
Main hypotheses of CHD study: Does a standardized PEEP-Titration maneuver, to optimize end-expiratory lung volume improve:
- cardiac performance
- lung function
Does it make a difference in:
- length of ventilation
- ventilation/perfusion mismatch of the lung
- need for vasopressor support?
Main hypotheses of ECMO study:
Does a LVOM in children/infants with severe respiratory failure /ARDS
- improve lung compliance and gas exchange
- facilitate lung protective ventilation according to PALICC-2 guidelines
- improve lung aeration and V/Q-matching assessed with EIT
Does it make a difference in
- need for ECMO
- duration of ECMO runs
- hemodynamics stability
Read the detailed description
- The objective of the CHD study is to define the impact of a LVOM after cardiac surgery with CPB on hemodynamics and lung mechanics in children with congenital heart disease (CHD) undergoing surgery.
The Specific Aims of this work are:
Specific Aim 1:
Evaluate hemodynamics and lung mechanics during and after a LVOM:
In cases of children undergoing cardiac surgery all measurements will be performed with closed chest conditions.
Specific Aim 2:
Evaluate a potential benefit of lung volume optimization by performing PEEP titration on hemodynamics and lung mechanics compared to standard care without PEEP titration to optimize end-expiratory lung volume while maintaining same tidal volume targets in cases and controls.
Hypotheses:
- Hemodynamics and lung mechanics will be significantly different before and after LVOM. We expect that there will be little difference between intervention and control group before performing PEEP titration in the interventional group.
- Once the PEEP titration has been performed in the interventional group, we hypothesize that patients who received the intervention will have improved hemodynamics and lung mechanics with modest PEEP while receiving the same tidal volume than the control group (U-shaped curves).
Rationale: Surgery with cardiopulmonary bypass typically involves an interruption of mechanical ventilation while CPB is running. This is oftentimes associated with atelectasis formation and impaired gas exchange due to reduced end-expiratory lung volume. While there have been few studies in adults that have shown that optimization of lung volume by performing PEEP titration after CPB can significantly improve Cardiac Index and right ventricular function, there have been only very few prospective pediatric studies which assessed the impact of different PEEP settings on hemodynamics, and lung mechanics after cardiac surgery in children. Because these patients are generally among the most fragile postoperative patients, it is critical to understand if specific ventilator strategies can help mitigate any negative hemodynamic consequences after surgery. The purpose of this study is to understand the critical cardiopulmonary interactions that occur with changes in lung volumes, and to determine optimal approaches to mechanical ventilation under these different circumstances.
Cardiopulmonary interactions differ based on the underlying cardiac anatomy and physiology. Most studies of cardiopulmonary interactions following surgery for congenital heart disease have examined the difference between positive and negative pressure ventilation. This work consistently showed improvement in cardiac output and pulmonary blood flow with negative pressure ventilation, while positive pressure ventilation was associated with decreased cardiac output. However, these studies have been conducted in the 1990's and positive pressure ventilation has changed significantly in the meantime.
Similarly, while patients with left ventricular dysfunction generally benefit from positive pressure ventilation, there is little data regarding the hemodynamic effects of positive pressure ventilation on right ventricular performance.
Modulating pulmonary vascular resistance by optimizing lung volumes might be a promising approach to improve both lung mechanics and hemodynamics. Studies in this population have focused more on the effects of FiO2 and hyperventilation than on respiratory mechanics and cardiopulmonary interactions.
- The objective of the ECMO study is to evaluate if a LVOM in children and infants with ARDS at risk or need for ECMO has an impact on ECMO prevention or shortening of ECMO duration.
Specific aims:
- assess the effect of LVOM on lung aeration and perfusion assessed with EIT
- assess the effect of LVOM on hemodynamics with (primarily VV-ECMO) and without ECMO
- evaluate if LVOM can prevent the need for ECMO
- evaluate if LVOM can shorten ECMO duration
Rationale:
Children with NARDS or PARDS usually have reduced lung volumes. Typically ECMO is initiated when oxygenation index approaches 40 with further deterioration of hypercarbia, hemodynamics and worsening hypoxemia. Current treatment strategies include reducing ventilatory support on ECMO ("rest settings") which is typically followed by a "whiteout" of the lungs reflecting lung collapse and fluid infiltration. Usually within 10 days of ECMO support invasive ventilation is gradually increased to re-open the lung and allow for ECMO weaning. Optimizing lung volumes by performing a LVOM early on in the disease process might be beneficial to wean ECMO faster or even prevent its need by avoiding massive lung collapse during rest settings in patients that have high potential for lung recruitability.
- Conditions
- Congenital Heart Disease, Cardiopulmonary Bypass, Cardiac Surgery, Mechanical Ventilation, Positive End-expiratory Pressure (PEEP), Lung Volume
- Being tested
- End-expiratory lung volume optimization maneuver with PEEP titration, Standard Care (in control arm)
- Keywords
- cardiopulmonary interactions, end-expiratory lung volume, PEEP titration, ARDS, ECMO, cardiopulmonary bypass
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End-expiratory lung volume optimization maneuver with PEEP titrationProcedure or surgery
CHD study: PEEP titration (incremental/decremental) will be performed to optimize lung volume and find levels of PEEP corresponding to the best lung compliance at the end of surgery. Typically PEEP levels between 10-20cmH2O will be applied based on individual response of patients' lung mechanics. Tidal volume will be kept constant at 6ml/kg in cases and controls. Driving pressures will be limited to 15cmH2O. Balance of CO2 will be guaranteed by adjusting respiratory rate.
ECMo study: PEEP/CDP titration (incremental/decremental) will be performed to optimize lung volume and find levels of PEEP/CDP corresponding to the best lung compliance, best match of overdistension and collapse and homogenization of tidal volume distribution (EIT) .
Standard Care (in control arm)Procedure or surgery
CHD study: Patients will receive pressure controlled ventilation with target tidal volume of 6ml/kg and PEEP of 5cmH2O. Driving pressures are limited to 15cmH2O. No LVOM will be applied.
ECMO study: patients will receive standard ECMO ventilation (PEEP 10cmH2O and PiP 20cmH2O) without performing LVOM
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | CHD study: This group receives so called standard of care. This includes relatively low levels of PEEP (5cmH2O in case of planned surgery) and no standardized PEEP titration
ECMO study: This group receives so called standard of care. This includes PEEP of 10cmH2O, peak inspiratory pressures of 20cmH2O and no standardized PEEP titration Receives: Procedure: Standard Care (in control arm) |
| treatment | Experimental | CHD study: This group receives an individual lung volume optimization maneuver with PEEP titration. PEEP titration is performed while monitoring lung mechanics to optimize end-expiratory lung volume and find final "best PEEP".
ECMO study: This group receives an individual lung volume optimization maneuver with PEEP titration during conventional or CDP titration with high frequency oscillatory ventilation. PEEP/CDP titration is performed while monitoring lung mechanics and EIT indices to optimize end-expiratory lung volume and find final "best PEEP/CDP". Receives: Procedure: End-expiratory lung volume optimization maneuver with PEEP titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
CHD study: Cardiac Index (L/min/BSA) 2. ECMO study: shortening of ECMO duration (Hours)
CHD study: assessed by using POCUS ECMO study: time course (Hours)
Measured: perioperatively/periprocedurally
Secondary outcomes (6)
lung mechanics
lung compliance (ml/cmH2O/kg)
Measured: perioperatively/periprocedurally
right ventricular performance
TAPSE PAAT Strain
Measured: perioperatively/periprocedurally
Ventilation distribution
EIT
Measured: perioperatively/periprocedurally
Lung perfusion
assessed with EIT (electrical impedance tomography)
Measured: perioperatively/periprocedurally
dead space
pulmonary dead-space fraction (Vd/Vt)
Measured: perioperatively/periprocedurally
avDO2
difference in arteriovenous oxygen content
Measured: perioperatively/periprocedurally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start5 Dec 2025
- Primary completion31 May 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The type of intervention is one of clinical management (ventilatory management) and does not include a specific drug or biological
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Clausen, MD, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193719
- Sponsor's protocol ID
- EA2/070/25
- Acronym
- ILOCO
- Status last verified
- Oct 2026
- First submitted
- 11 Sep 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Personalized Lung Volume Optimization Maneuver on Lung Aeration and Cardiac Performance in Mechanically Ventilated Children
- ClinicalTrials.gov ID
- NCT07193719
- Acronym / sponsor ID
- ILOCO / EA2/070/25
- Conditions
- Congenital Heart Disease, Cardiopulmonary Bypass, Cardiac Surgery, Mechanical Ventilation, Positive End-expiratory Pressure (PEEP), Lung Volume
- Keywords
- cardiopulmonary interactions, end-expiratory lung volume, PEEP titration, ARDS, ECMO, cardiopulmonary bypass
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 26 Sep 2025 (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 randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver (LVOM) is beneficial in
- study) children undergoing biventricular repair of their congenital heart disease (CHD) with cardiopulmonary bypass and
- study) in children with severe respiratory failure at risk for or need for ECMO.
The main questions it aims to answer are:
Main hypotheses of CHD study: Does a standardized PEEP-Titration maneuver, to optimize end-expiratory lung volume improve:
- cardiac performance
- lung function
Does it make a difference in:
- length of ventilation
- ventilation/perfusion mismatch of the lung
- need for vasopressor support?
Main hypotheses of ECMO study:
Does a LVOM in children/infants with severe respiratory failure /ARDS
- improve lung compliance and gas exchange
- facilitate lung protective ventilation according to PALICC-2 guidelines
- improve lung aeration and V/Q-matching assessed with EIT
Does it make a difference in
- need for ECMO
- duration of ECMO runs
- hemodynamics stability
Detailed description
- The objective of the CHD study is to define the impact of a LVOM after cardiac surgery with CPB on hemodynamics and lung mechanics in children with congenital heart disease (CHD) undergoing surgery.
The Specific Aims of this work are:
Specific Aim 1:
Evaluate hemodynamics and lung mechanics during and after a LVOM:
In cases of children undergoing cardiac surgery all measurements will be performed with closed chest conditions.
Specific Aim 2:
Evaluate a potential benefit of lung volume optimization by performing PEEP titration on hemodynamics and lung mechanics compared to standard care without PEEP titration to optimize end-expiratory lung volume while maintaining same tidal volume targets in cases and controls.
Hypotheses:
- Hemodynamics and lung mechanics will be significantly different before and after LVOM. We expect that there will be little difference between intervention and control group before performing PEEP titration in the interventional group.
- Once the PEEP titration has been performed in the interventional group, we hypothesize that patients who received the intervention will have improved hemodynamics and lung mechanics with modest PEEP while receiving the same tidal volume than the control group (U-shaped curves).
Rationale: Surgery with cardiopulmonary bypass typically involves an interruption of mechanical ventilation while CPB is running. This is oftentimes associated with atelectasis formation and impaired gas exchange due to reduced end-expiratory lung volume. While there have been few studies in adults that have shown that optimization of lung volume by performing PEEP titration after CPB can significantly improve Cardiac Index and right ventricular function, there have been only very few prospective pediatric studies which assessed the impact of different PEEP settings on hemodynamics, and lung mechanics after cardiac surgery in children. Because these patients are generally among the most fragile postoperative patients, it is critical to understand if specific ventilator strategies can help mitigate any negative hemodynamic consequences after surgery. The purpose of this study is to understand the critical cardiopulmonary interactions that occur with changes in lung volumes, and to determine optimal approaches to mechanical ventilation under these different circumstances.
Cardiopulmonary interactions differ based on the underlying cardiac anatomy and physiology. Most studies of cardiopulmonary interactions following surgery for congenital heart disease have examined the difference between positive and negative pressure ventilation. This work consistently showed improvement in cardiac output and pulmonary blood flow with negative pressure ventilation, while positive pressure ventilation was associated with decreased cardiac output. However, these studies have been conducted in the 1990's and positive pressure ventilation has changed significantly in the meantime.
Similarly, while patients with left ventricular dysfunction generally benefit from positive pressure ventilation, there is little data regarding the hemodynamic effects of positive pressure ventilation on right ventricular performance.
Modulating pulmonary vascular resistance by optimizing lung volumes might be a promising approach to improve both lung mechanics and hemodynamics. Studies in this population have focused more on the effects of FiO2 and hyperventilation than on respiratory mechanics and cardiopulmonary interactions.
- The objective of the ECMO study is to evaluate if a LVOM in children and infants with ARDS at risk or need for ECMO has an impact on ECMO prevention or shortening of ECMO duration.
Specific aims:
- assess the effect of LVOM on lung aeration and perfusion assessed with EIT
- assess the effect of LVOM on hemodynamics with (primarily VV-ECMO) and without ECMO
- evaluate if LVOM can prevent the need for ECMO
- evaluate if LVOM can shorten ECMO duration
Rationale:
Children with NARDS or PARDS usually have reduced lung volumes. Typically ECMO is initiated when oxygenation index approaches 40 with further deterioration of hypercarbia, hemodynamics and worsening hypoxemia. Current treatment strategies include reducing ventilatory support on ECMO ("rest settings") which is typically followed by a "whiteout" of the lungs reflecting lung collapse and fluid infiltration. Usually within 10 days of ECMO support invasive ventilation is gradually increased to re-open the lung and allow for ECMO weaning. Optimizing lung volumes by performing a LVOM early on in the disease process might be beneficial to wean ECMO faster or even prevent its need by avoiding massive lung collapse during rest settings in patients that have high potential for lung recruitability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The type of intervention is one of clinical management (ventilatory management) and does not include a specific drug or biological
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Procedure: Standard Care (in control arm)CHD study: This group receives so called standard of care. This includes relatively low levels of PEEP (5cmH2O in case of planned surgery) and no standardized PEEP titration ECMO study: This group receives so called standard of care. This includes PEEP of 10cmH2O, peak inspiratory pressures of 20cmH2O and no standardized PEEP titration |
| treatment | Experimental | Procedure: End-expiratory lung volume optimization maneuver with PEEP titrationCHD study: This group receives an individual lung volume optimization maneuver with PEEP titration. PEEP titration is performed while monitoring lung mechanics to optimize end-expiratory lung volume and find final "best PEEP". ECMO study: This group receives an individual lung volume optimization maneuver with PEEP titration during conventional or CDP titration with high frequency oscillatory ventilation. PEEP/CDP titration is performed while monitoring lung mechanics and EIT indices to optimize end-expiratory lung volume and find final "best PEEP/CDP". |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- congenital heart disease
- surgery with cardiopulmonary bypass
Key exclusion criteria (10 listed)
- single ventricle physiology
- ECMO/VAD
- <36weeks of gestational age
- chronic lung disease
- Endotracheal tube leak > 15%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| End-expiratory lung volume optimization maneuver with PEEP titrationCHD study: PEEP titration (incremental/decremental) will be performed to optimize lung volume and find levels of PEEP corresponding to the best lung compliance at the end of surgery. Typically PEEP levels between 10-20cmH2O will be applied based on individual response of patients' lung mechanics. Tidal volume will be kept constant at 6ml/kg in cases and controls. Driving pressures will be limited to 15cmH2O. Balance of CO2 will be guaranteed by adjusting respiratory rate. ECMo study: PEEP/CDP titration (incremental/decremental) will be performed to optimize lung volume and find levels of PEEP/CDP corresponding to the best lung compliance, best match of overdistension and collapse and homogenization of tidal volume distribution (EIT) . | Procedure or surgery | treatment |
| Standard Care (in control arm)CHD study: Patients will receive pressure controlled ventilation with target tidal volume of 6ml/kg and PEEP of 5cmH2O. Driving pressures are limited to 15cmH2O. No LVOM will be applied. ECMO study: patients will receive standard ECMO ventilation (PEEP 10cmH2O and PiP 20cmH2O) without performing LVOM | Procedure or surgery | control |
Primary outcome
CHD study: Cardiac Index (L/min/BSA) 2. ECMO study: shortening of ECMO duration (Hours)
Time frame: perioperatively/periprocedurally
CHD study: assessed by using POCUS ECMO study: time course (Hours)
6 secondary outcomes
lung mechanics
Time frame: perioperatively/periprocedurally
right ventricular performance
Time frame: perioperatively/periprocedurally
Ventilation distribution
Time frame: perioperatively/periprocedurally
Lung perfusion
Time frame: perioperatively/periprocedurally
dead space
Time frame: perioperatively/periprocedurally
avDO2
Time frame: perioperatively/periprocedurally
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing End-expiratory lung volume optimization maneuver with PEEP titration in people with Congenital Heart Disease and Cardiopulmonary Bypass, run by Charite University, Berlin, Germany 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 2 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan C Clausen, MD (004970712984751, jan.clausen@posteo.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CHD study: Cardiac Index (L/min/BSA) 2. ECMO study: shortening of ECMO duration (Hours) (time frame: perioperatively/periprocedurally). 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 15 Oct 2026.