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

NCT07193719 | Recruiting Phase 1

• 1 other identifier: EA2/070/25
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver (LVOM) is beneficial in

• 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

Conditions

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

Outcome Measures

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)

  perioperatively/periprocedurally

Secondary Outcomes (6)

• lung mechanics

  perioperatively/periprocedurally

• right ventricular performance

  perioperatively/periprocedurally

• Ventilation distribution

  perioperatively/periprocedurally

• Lung perfusion

  perioperatively/periprocedurally

• dead space

  perioperatively/periprocedurally

Study Arms (2)

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

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".

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

Interventions

End-expiratory lung volume optimization maneuver with PEEP titration PROCEDURE

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) .

treatment

Standard Care (in control arm) PROCEDURE

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

control

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• congenital heart disease
• surgery with cardiopulmonary bypass

You may not qualify if:

• single ventricle physiology
• ECMO/VAD
• \<36weeks of gestational age
• chronic lung disease
• Endotracheal tube leak \> 15%
• lack of informed consent from parents.
• patients with respiratory failure on ECMO or at risk for ECMO
• invasive ventilation
• \- severe lung hypoplasia or interstitial lung disease

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

German Heart Center of the Charité

Berlin, 13353, Germany

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Jan C Clausen, MD

CONTACT

00493045932800; jan.clausen@posteo.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statisticians
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Cardiologist/Intensivist

Model Details: The type of intervention is one of clinical management (ventilatory management) and does not include a specific drug or biological

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 26, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

DE (1)