Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07193719 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: ILOCO
StatusRecruiting
PhasePhase 1/2
Started2025-12-05
View on ClinicalTrials.gov ↗

Amendment history

2026-04-05
Study Identification, Study Status v5
Study title-174 characters
Influence of Personalized Lung Volume Optimization Maneuver inon VentilatedLung ChildrenFunction onand Cardiac Output and Lung CompliancePerformance in Children With Congenital Heart Disease Undergoing Surgical Repair and on Prevention of Need for ECMO or Shortening of ECMO Duration in Children With Severe Respiratory Failure
2026-02-19
Study Status, Conditions v4
Re-verified, no change to tracked fields
2026-01-30
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v3
Eligibility criteria+6 characters
GroupCHD 1 study: Inclusion Criteria congenital heart disease surgery with car [...] heal tube leak > 15% lack of informed consent from parents. GroupECMO 2study Inclusion Criteria patients with respiratory failure on ECM [...]
Primary endpoints1 entry, revised
CHD study: Cardiac Index (L/min/BSA) 2. ECMO study: shortening of ECMO duration (Hours)
Study description+1,121 characters
1) The objective of thisthe CHD study is to define the impact of variablea levelsLVOM ofafter PEEPcardiac andsurgery with CPB 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: Evalua [...] ithout PEEP titration to optimize end-expiratory lung volume while maintaining same tidal volume targets in cases and controls. Hypotheses: Hemodynamics and lung mechanics will be signif [...] on respiratory mechanics and cardiopulmonary interactions. Children2) The objective of the ECMO stud [...] [...]
Study title+55 characters
[...] ith Congenital Heart Disease Undergoing Surgical Repair and on Prevention of Need for ECMO or Shortening of ECMO Duration in Children RequiringWith ECMO forSevere Respiratory Failure
2026-01-21
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2026-01-05→confirmed 2025-12-05
Eligibility criteria+192 characters
Group 1 Inclusion Criteria congenital heart disease surgery with car [...] cheal tube leak > 15% lack of informed consent from parents. Group 2 Inclusion Criteria patients with respiratory failure on ECMO or at risk for ECMO invasive ventilation Exclusion Criteria: - severe lung hypoplasia or interstitial lung disease
Study description+29 characters
[...] of PEEP and on hemodynamics and lung mechanics in children undergoing biventricular repair of theirwith 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 atduring threeand differentafter timea pointsLVOM: In while maintaining consistent ventilation with 6ml/kg, in infants with biventricular physiology who undergo surgical repaircases of theirchildren CHD: beforeundergoing cardiopulmonary bypass (CPB) after CPB at the end ofcardiac surgery All all measurements will be perform [...] [...]
Study sitesdetails revised at 1 of 1 site
Study title+49 characters
Influence of Lung Volume Optimization AfterManeuver Cardiopulmonaryin BypassVentilated Children on Cardiac Output and Lung Compliance in Children Undergoing Biventricular Repair of TheirWith Congenital Heart Disease Undergoing Surgical Repair and in Children Requiring ECMO for Respiratory Failure
2025-09-30
Study Status, Contacts/Locations v1
Study sites0→1
2025-09-17
Original filing
The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver (LVOM) is beneficial in 1. study) children undergoing biventricular repair of their congenital heart disease (CHD) with cardiopulmonary bypass and 2. study) in children with severe respiratory failure at risk for or need for ECMO. The main questions it aims to answer are: Main hypotheses of CHD study: 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? 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
Trial Details
NCT Number NCT07193719
Lead Sponsor Charite University, Berlin, Germany
Conditions Congenital Heart Disease, Cardiopulmonary Bypass, Cardiac Surgery, Mechanical Ventilation, Positive End-expiratory Pressure (PEEP), Lung Volume, Lung Mechanics, Hemodynamic Changes +3 more
Enrollment 80 participants
Start Date 2025-12-05
Primary Completion 2027-05-31 (estimated)
Study Completion 2027-12-20 (estimated)
Updated on ClinicalTrials.gov 2026-04-09