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RecruitingNCT07193719ILOCOUpdated Apr 9, 2026

Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children

A Phase 1/2 interventional study of End-expiratory lung volume optimization maneuver with PEEP titration and Standard Care (in control arm) in Congenital Heart Disease, Cardiopulmonary Bypass and Cardiac Surgery, sponsored by Charite University, Berlin, Germany. Recruiting at 1 site in Germany. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-04-09.

Sponsored by Charite University, Berlin, Germany · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
0 Years to 18 Years
Sex
All
01

Study 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. 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
Read the detailed description

1) 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:

  1. 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.
  2. 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.

2) 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.

02

Conditions studied

  • Congenital Heart Disease
  • Cardiopulmonary Bypass
  • Cardiac Surgery
  • Mechanical Ventilation
  • Positive End-expiratory Pressure (PEEP)
  • Lung Volume
  • Lung Mechanics
  • Hemodynamic Changes
  • Children
  • ARDS
  • ECMO

Keywords

  • cardiopulmonary interactions
  • end-expiratory lung volume
  • PEEP titration
  • ARDS
  • ECMO
  • cardiopulmonary bypass
03

In context

Heart Defects, Congenital

1,007 studies on the registry are indexed under Heart Defects, Congenital; 257 are open to participants now.

This study's planned enrollment of 80 is above the median of 60 across 524 interventional studies indexed under Heart Defects, Congenital.

Browse Heart Defects, Congenital studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

CHD study:

Inclusion Criteria

  • congenital heart disease
  • surgery with cardiopulmonary bypass

Exclusion Criteria:

  • single ventricle physiology
  • ECMO/VAD
  • \<36weeks of gestational age
  • chronic lung disease
  • Endotracheal tube leak > 15%
  • lack of informed consent from parents.

ECMO study Inclusion Criteria

  • patients with respiratory failure on ECMO or at risk for ECMO
  • invasive ventilation

Exclusion Criteria:

- severe lung hypoplasia or interstitial lung disease

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    control

    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

    Procedure: Standard Care (in control arm)

  • Experimental
    treatment

    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".

    Procedure: End-expiratory lung volume optimization maneuver with PEEP titration

Interventions

  • ProcedureEnd-expiratory lung volume optimization maneuver with PEEP titration

    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) .

  • ProcedureStandard 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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: perioperatively/periprocedurally

Secondary outcomes

  1. lung mechanics

    lung compliance (ml/cmH2O/kg)

    Time frame: perioperatively/periprocedurally

  2. right ventricular performance

    TAPSE PAAT Strain

    Time frame: perioperatively/periprocedurally

  3. Ventilation distribution

    EIT

    Time frame: perioperatively/periprocedurally

  4. Lung perfusion

    assessed with EIT (electrical impedance tomography)

    Time frame: perioperatively/periprocedurally

  5. dead space

    pulmonary dead-space fraction (Vd/Vt)

    Time frame: perioperatively/periprocedurally

  6. avDO2

    difference in arteriovenous oxygen content

    Time frame: perioperatively/periprocedurally

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07193719
Lead sponsor
Charite University, Berlin, Germany
Responsible party
Jan Clausen (Pediatric Cardiologist/Intensivist, Charite University, Berlin, Germany) — Principal investigator
First posted
Sep 26, 2025
Start date
Dec 5, 2025
Primary completion
May 31, 2027 (estimated)
Completion
Dec 20, 2027 (estimated)
Last update
Apr 9, 2026

Study contacts

Jan C Clausen, MD
Contact
jan.clausen@posteo.de
00493045932800

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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