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

NCT ID: NCT07193719

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-05
• Study Completion Date: 2027-12-20

Brief Summary

The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver is beneficial in children undergoing biventricular repair of their congenital heart disease and in children on ECMO.

The main questions it aims to answer are:

1. Does a standardized PEEP-Titration maneuver, to optimize end-expiratory lung volume improve:

• cardiac performance
• lung function

2. Does it make a difference in:

• length of ventilation
• ventilation/perfusion mismatch of the lung
• need for vasopressor support?

Detailed Description

The objective of this study is to define the impact of variable levels of PEEP and on hemodynamics and lung mechanics in children with congenital heart disease (CHD) undergoing surgery and in those needing ECMO.

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.

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.

Children and infants with ARDS requiring ECMO usually have reduced lung volumes. Optimizing lung volumes by performing a LVOM might be beneficial to wean ECMO faster or even prevent its need.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control

This group receives so called standard of care. This includes relatively low levels of PEEP (5cmH2O in case of planned surgery; 10cmH2O when on ECMO for respiratory failure) and no standardized PEEP titration

Group Type: ACTIVE_COMPARATOR

Standard Care (in control arm)

Intervention Type: PROCEDURE

Surgical Patients will receive pressure controlled ventilation with target tidal volume of 6ml/kg and PEEP of 5cmH2O. Driving pressures are limited to 15cmH2O. ECMO patients will receive standard ECMO ventilation (PEEP 10cmH2O and PiP 20cmH2O)

treatment

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".

Group Type: EXPERIMENTAL

End-expiratory lung volume optimization maneuver with PEEP titration

Intervention Type: PROCEDURE

PEEP titration (incremental/decremental) will be performed to optimize lung volume and find levels of PEEP corresponding to the best lung compliance. 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 both arms in case of planned surgery but not in patients on ECMO. Driving pressures will be limited to 15cmH2O. Balance of CO2 will be guaranteed by adjusting respiratory rate.

Interventions

End-expiratory lung volume optimization maneuver with PEEP titration

PEEP titration (incremental/decremental) will be performed to optimize lung volume and find levels of PEEP corresponding to the best lung compliance. 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 both arms in case of planned surgery but not in patients on ECMO. Driving pressures will be limited to 15cmH2O. Balance of CO2 will be guaranteed by adjusting respiratory rate.

Intervention Type: PROCEDURE

Standard Care (in control arm)

Surgical Patients will receive pressure controlled ventilation with target tidal volume of 6ml/kg and PEEP of 5cmH2O. Driving pressures are limited to 15cmH2O. ECMO patients will receive standard ECMO ventilation (PEEP 10cmH2O and PiP 20cmH2O)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• congenital heart disease
• surgery with cardiopulmonary bypass

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

Exclusion Criteria

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

• severe lung hypoplasia or interstitial lung disease

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Jan Clausen

Pediatric Cardiologist/Intensivist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

German Heart Center of the Charité

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Jan C Clausen, MD

Role: CONTACT

jan.clausen@posteo.de

00493045932800

Facility Contacts

Jan C Clausen, MD

Role: primary

jan-christoph.clausen@charite.de

Other Identifiers

EA2/070/25

Identifier Type: -

Identifier Source: org_study_id