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Congenital Heart DiseasePhase 1/2ILOCO-CHDNCT07486167

Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair

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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The aim of this randomized interventional multi-center clinical trial is to determine whether a standardized lung volume optimization maneuver (LVOM), including PEEP titration, improves outcomes in children undergoing biventricular repair for congenital heart disease (CHD) with cardiopulmonary bypass. Read more about this study

Who is it for?
Ages 0 days to 18 years
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
1 Jan 2027to 30 Jun 2029
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 days 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jan C Clausen, MD contact

004970712984751

jan.clausen@posteo.de

Germany1 site

  • University Hospital Tübingen, PICU

    Tübingen, 72076

Other trials in Germany

About this study

Official title: Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Function in Children With Congenital Heart Disease

The aim of this randomized interventional multi-center clinical trial is to determine whether a standardized lung volume optimization maneuver (LVOM), including PEEP titration, improves outcomes in children undergoing biventricular repair for congenital heart disease (CHD) with cardiopulmonary bypass.

The primary hypothesis is that optimizing end-expiratory lung volume through a standardized PEEP titration maneuver improves cardiac performance and lung function.

Secondary objectives are to evaluate whether this strategy reduces duration of mechanical ventilation, improves hemodynamics and ventilation-perfusion matching, and decreases the need for vasopressor support.

Read the detailed description

Cardiopulmonary bypass is associated with interruption of ventilation, leading to atelectasis, reduced end-expiratory lung volume, and increased pulmonary vascular resistance (PVR), which may impair right ventricular (RV) performance and overall cardiac output.

This study investigates whether a structured LVOM strategy can mitigate these effects by improving lung mechanics and cardiopulmonary interactions.

Specific Aims

Aim 1:

To quantify changes in hemodynamics and lung mechanics induced by LVOM under standardized postoperative (closed-chest) conditions.

Aim 2:

To compare individualized PEEP titration versus standard ventilation in terms of effects on hemodynamics and lung mechanics, while maintaining consistent tidal volume targets across groups.

Hypotheses

LVOM will improve lung mechanics and hemodynamic parameters. No significant between-group differences are expected prior to intervention. After PEEP titration, the intervention group will demonstrate superior cardiopulmonary function at moderate PEEP levels, reflecting the U-shaped relationship between lung volume and pulmonary vascular resistance (PVR).

Scientific Rationale

Cardiopulmonary bypass commonly results in atelectasis and loss of end-expiratory lung volume, contributing to increased PVR and RV afterload, with subsequent reduction in cardiac output.

Adult studies suggest that lung volume optimization through PEEP titration after CPB can improve cardiac index and RV performance. However, prospective pediatric data evaluating the interaction between ventilatory strategy, lung mechanics, and hemodynamics remain limited.

Given the central role of the right ventricle in coupling pulmonary and systemic circulation, optimizing lung volume may reduce RV afterload and improve overall cardiac performance.

Importantly, pulmonary vascular resistance follows a U-shaped relationship with lung volume, with increased resistance at both low (atelectasis) and high (overdistension) lung volumes. Individualized PEEP titration may therefore identify an optimal range that minimizes PVR while preserving hemodynamic stability.

This study addresses a critical gap by systematically evaluating cardiopulmonary interactions under contemporary ventilation strategies in pediatric cardiac surgery.

Being tested
End-expiratory lung volume optimization maneuver with PEEP titration, Standard Care (in control arm)
Keywords
cardiopulmonary interactions, end-expiratory lung volume, electrical impedance tomography, PEEP titration
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

    PEEP titration (incremental/decremental) will be performed at the end of surgery to optimize lung volume and find levels of PEEP corresponding to the "best" lung compliance and "best" compromise of overdistension and collapse and "best" homogenization of tidal volume distribution assessed with EIT. PEEP levels will be applied based on individual response of patients' lung mechanics and EIT measures. 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.

  • Standard Care (in control arm)Procedure or surgery

    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.

Study groups in NCT07486167
Study groupRoleWhat they receive
ControlActive comparatorThis 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.
Receives: Procedure: Standard Care (in control arm)
TreatmentExperimentalThis group receives an individual lung volume optimization maneuver with PEEP titration. PEEP titration is performed while monitoring lung mechanics and EIT indices of overdistension and collapse and regional tidal volume distribution to optimize end-expiratory lung volume and find final "best PEEP". If possible lung perfusion will be assessed with EIT to evaluate V/Q-matching.
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.

  1. Cardiac Index (L/min/BSA)

    assessed by using POCUS

    Measured: perioperatively

Secondary outcomes (6)

  1. lung mechanics

    lung compliance (ml/cmH2O/kg)

    Measured: perioperatively

  2. right ventricular performance

    TAPSE PAAT Strain

    Measured: perioperatively

  3. ventilation distribution

    EIT

    Measured: perioperatively

  4. lung perfurision

    EIT

    Measured: perioperatively

  5. dead space fraction

    pulmonary dead-space fraction (Vd/Vt)

    Measured: perioperatively

  6. avDO2

    difference in arteriovenous oxygen content

    Measured: perioperatively

Timeline

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

  1. First posted20 Mar 2026
  2. Study start1 Jan 2027 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07486167
Sponsor's protocol ID
EA2_070_25
Acronym
ILOCO-CHD
Status last verified
Oct 2026
First submitted
17 Mar 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • "Electrical impedance tomography during open heart surgery and on the cardiac icu is feasible to monitor ventilation in children with congenital heart disease" J.-C. Clausen, M. Emeis, M. Kleine-Brueggeney, M.-Y. Cho, M. Kneyber and O. Miera Intensive Care Medicine - Paediatric and Neonatal 2024 Vol. 2 Issue 1 Pages 19 DOI: 10.1007/s44253-024-00043-4

  • Clausen JC, Emeis M, Hollander R, Miera O, Kleine-Brueggeney M, Blokpoel RGT, Garfias-Veitl T, Asendorf T, Vadiunec VV, Photiadis J, Berger F, Kneyber MCJ. Effect of Positive End-Expiratory Pressure on Cardiac Index and Right Ventricular Performance in Ventilated Children Post-Cardiac Surgery. Pediatr Crit Care Med. 2026 Feb 1;27(2):176-186. doi: 10.1097/PCC.0000000000003880. Epub 2025 Dec 19.

    PubMed 41416857

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 6 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: opening soon, 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?

Cardiac Index (L/min/BSA) (time frame: perioperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07486167, which also lists 2 linked publications.

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.

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