Influence of Lung Volume Optimization After Cardiopulmonary Bypass on Cardiac Output and Lung Compliance in Children Undergoing Biventricular Repair of Their Congenital Heart Disease

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07193719
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver after cardiac surgery with cardiopulmonary bypass (CPB) is beneficial in children undergoing biventricular repair of their congenital heart disease.

The main questions it aims to answer are:

1. Does a standardized PEEP-Titration maneuver, to optimize end-expiratory lung volume after cardiac surgery with CPB, 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 undergoing biventricular repair of their congenital heart disease (CHD).

The Specific Aims of this work are:

Specific Aim 1:

Evaluate hemodynamics and lung mechanics at three different time points while maintaining consistent ventilation with 6ml/kg, in infants with biventricular physiology who undergo surgical repair of their CHD:

1. before cardiopulmonary bypass (CPB)

2. after CPB

3. at the end of 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 after CPB 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 CPB. 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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-11
• Study First Submitted QC: 2025-09-17
• Study First Posted: 2025-09-26
• Last Update Submitted: 2025-09-30
• Last Update Posted: 2025-10-01
• Study Start: 2026-01-05
• Primary Completion: 2027-05-31
• Study Completion: 2027-12-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cardiac Index	perioperatively/periprocedurally	assessed by using POCUS

Secondary Outcome Measures

Name	Time	Method
lung mechanics	perioperatively/periprocedurally	lung compliance (ml/cmH2O/kg)
right ventricular performance	perioperatively/periprocedurally	TAPSE PAAT Strain
Ventilation distribution	perioperatively/periprocedurally	EIT
Lung perfusion	perioperatively/periprocedurally	assessed with EIT (electrical impedance tomography)
dead space	perioperatively/periprocedurally	pulmonary dead-space fraction (Vd/Vt)
avDO2	perioperatively/periprocedurally	difference in arteriovenous oxygen content

Trial Locations

Locations (1)

German Heart Center of the Charité; 🇩🇪 Berlin, Germany