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

NCT07486167 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: EA 2025/06/10
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lung Mechanics; Lung Volume; Hemodynamic Changes; Congenital Heart Disease; Cardiopulmonary Bypass; Peep Titration in Lung Protective Ventilation; Positive End-expiratory Pressure (PEEP); Mechanical Ventilation; Children; Cardiac Surgery

Keywords

cardiopulmonary interactions; end-expiratory lung volume; electrical impedance tomography; PEEP titration

Outcome Measures

Primary Outcomes (1)

• Cardiac Index (L/min/BSA)

  assessed by using POCUS

  perioperatively

Secondary Outcomes (6)

• lung mechanics

  perioperatively

• right ventricular performance

  perioperatively

• ventilation distribution

  perioperatively

• lung perfurision

  perioperatively

• dead space fraction

  perioperatively

Study Arms (2)

Control

ACTIVE COMPARATOR

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.

Procedure: Standard Care (in control arm)

Treatment

EXPERIMENTAL

This 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.

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

Interventions

Standard Care (in control arm) PROCEDURE

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.

Control

End-expiratory lung volume optimization maneuver with PEEP titration PROCEDURE

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.

Treatment

Eligibility Criteria

• Age: 0 Days - 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.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

German Heart Center of the Charité

Berlin, 13353, Germany

Location

Related Publications (2)

• "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

  BACKGROUND

• 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.

  PMID: 41416857 BACKGROUND

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: Principal Investigator

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: March 17, 2026
• First Posted: March 20, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

DE (1)