Language: BG BG
← Back to results
Not yet recruiting Phase 1/2 NCT07486167

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

Phase 1/2 – combined early trial
Conditions: Congenital Heart Disease Cardiopulmonary Bypass Mechanical Ventilation Peep Titration in Lung Protective Ventilation Positive End-expiratory Pressure (PEEP) Lung Volume Lung Mechanics Children Hemodynamic Changes Cardiac Surgery

Sponsor: Charite University, Berlin, Germany

trial.available_in: БГ
Overview
The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver (LVOM) is beneficial in children undergoing biventricular repair of their congenital heart disease (CHD) with cardiopulmonary bypass. Main hypotheses: 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?
Description
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. The investigators 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, the investigators 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
Who can participate
Inclusion Criteria: * 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.
Interventions
End-expiratory lung volume optimization maneuver with PEEP titration
PROCEDURE
Standard Care (in control arm)
PROCEDURE
Locations 1
Germany (1)
German Heart Center of the Charité
Berlin
Technical details
Status
Not yet recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
0 Days
Maximum age
18 Years
Healthy volunteers
No
Start date
01.09.2026
Completion date
31.12.2028
Registry ID
NCT07486167
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.