Influence of a Personalized Lung Volume Optimization Maneuver on Lung Aeration and Cardiac Performance in Mechanically Ventilated Children
New lung maneuver tested in children with heart or breathing problems
Plain English Summary
Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children is a Phase 2 clinical trial sponsored by Charite University, Berlin, Germany studying Congenital Heart Disease, Cardiopulmonary Bypass, Cardiac Surgery, Mechanical Ventilation, Positive End-expiratory Pressure (PEEP), Lung Volume, Lung Mechanics, Hemodynamic Changes, Children, ARDS. This study tests a new way to adjust breathing support for children who have serious heart conditions or severe breathing problems. It is for children undergoing heart surgery with a heart-lung machine or those with severe breathing failure. Participation involves adjusting breathing machine settings to find the best lung volume for each child. Standard breathing support is the alternative for the control group. The trial aims to enroll 80 participants.
Official Summary
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
Who Can Participate
Here is what you need to know about eligibility for this trial. Children with congenital heart disease needing surgery with a heart-lung machine can join. Children with severe breathing failure needing a breathing machine or ECMO can join. Children cannot join if they have certain heart conditions (single ventricle), are very premature, have chronic lung disease, or have a significant air leak in their breathing tube. Parents must provide informed consent for their child to participate. This trial is studying Congenital Heart Disease, Cardiopulmonary Bypass, Cardiac Surgery, Mechanical Ventilation, Positive End-expiratory Pressure (PEEP), Lung Volume, Lung Mechanics, Hemodynamic Changes, Children, ARDS, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how well the heart pumps blood and how long children need breathing support, aiming to show that the new maneuver improves these critical functions. The specific primary outcome measures are: CHD study: Cardiac Index (L/min/BSA) 2. ECMO study: shortening of ECMO duration (Hours) (perioperatively/periprocedurally). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial aims to improve breathing and heart function in critically ill children, addressing a gap in optimizing lung support during complex medical procedures. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Congenital Heart Disease, Cardiopulmonary Bypass, Cardiac Surgery, Mechanical Ventilation, Positive End-expiratory Pressure (PEEP), Lung Volume, Lung Mechanics, Hemodynamic Changes, Children, ARDS, where improved treatment options are needed.
Investor Insight
This trial focuses on a niche but critical area of pediatric critical care, with potential to improve outcomes for vulnerable patients and reduce healthcare resource utilization. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if this study is right for your child and what the potential benefits and risks are. Participation involves your child receiving a specific breathing adjustment maneuver, while others receive standard care. Day-to-day involvement will depend on your child's condition and treatment, but will focus on monitoring breathing and heart function. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: SINGLE
- Enrollment: 80 participants
Interventions
- PROCEDURE: End-expiratory lung volume optimization maneuver with PEEP titration — CHD study: PEEP titration (incremental/decremental) will be performed to optimize lung volume and find levels of PEEP corresponding to the best lung compliance at the end of surgery. 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 cases and controls. Driving pressures will be limited to 15cmH2O. Balance of CO2 will be guaranteed by adjusting respiratory rate. ECMo study: PEEP/CDP t
- PROCEDURE: Standard Care (in control arm) — CHD study: 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. ECMO study: patients will receive standard ECMO ventilation (PEEP 10cmH2O and PiP 20cmH2O) without performing LVOM
Primary Outcomes
- CHD study: Cardiac Index (L/min/BSA) 2. ECMO study: shortening of ECMO duration (Hours) (perioperatively/periprocedurally)
Secondary Outcomes
- lung mechanics (perioperatively/periprocedurally)
- right ventricular performance (perioperatively/periprocedurally)
- Ventilation distribution (perioperatively/periprocedurally)
- Lung perfusion (perioperatively/periprocedurally)
- dead space (perioperatively/periprocedurally)
Full Eligibility Criteria
CHD study: 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. ECMO study Inclusion Criteria * patients with respiratory failure on ECMO or at risk for ECMO * invasive ventilation Exclusion Criteria: \- severe lung hypoplasia or interstitial lung disease
Trial Locations
- German Heart Center of the Charité, Berlin, Germany
Frequently Asked Questions
What is clinical trial NCT07193719?
NCT07193719 is a Phase 2 INTERVENTIONAL study titled "Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children." It is currently recruiting and is sponsored by Charite University, Berlin, Germany. The trial targets enrollment of 80 participants.
What conditions does NCT07193719 study?
This trial investigates treatments for Congenital Heart Disease, Cardiopulmonary Bypass, Cardiac Surgery, Mechanical Ventilation, Positive End-expiratory Pressure (PEEP), Lung Volume, Lung Mechanics, Hemodynamic Changes, Children, ARDS. The primary condition under study is Congenital Heart Disease.
What treatments are being tested in NCT07193719?
The interventions being studied include: End-expiratory lung volume optimization maneuver with PEEP titration (PROCEDURE), Standard Care (in control arm) (PROCEDURE). CHD study: PEEP titration (incremental/decremental) will be performed to optimize lung volume and find levels of PEEP corresponding to the best lung compliance at the end of surgery. 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 cases and controls. Driving pressures will be limited to 15cmH2O. Balance of CO2 will be guaranteed by adjusting respiratory rate. ECMo study: PEEP/CDP t
What does Phase 2 mean for NCT07193719?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT07193719?
This trial is currently "Recruiting." It started on 2025-12-05. The estimated completion date is 2027-12-20.
Who is sponsoring NCT07193719?
NCT07193719 is sponsored by Charite University, Berlin, Germany. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07193719?
The trial aims to enroll 80 participants. The trial is currently recruiting and accepting new participants.
How is NCT07193719 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT07193719?
The primary outcome measures are: CHD study: Cardiac Index (L/min/BSA) 2. ECMO study: shortening of ECMO duration (Hours) (perioperatively/periprocedurally). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07193719 being conducted?
This trial is being conducted at 1 site, including Berlin (Germany).
Where can I find official information about NCT07193719?
The official record for NCT07193719 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07193719. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07193719 testing in simple terms?
This study tests a new way to adjust breathing support for children who have serious heart conditions or severe breathing problems. It is for children undergoing heart surgery with a heart-lung machine or those with severe breathing failure.
Why is this trial significant?
This trial aims to improve breathing and heart function in critically ill children, addressing a gap in optimizing lung support during complex medical procedures.
What are the potential risks of participating in NCT07193719?
Potential risks include discomfort from breathing tube adjustments and possible temporary worsening of breathing or heart function. Side effects are generally related to the underlying condition and the breathing support, and will be closely monitored. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07193719?
Ask your doctor if this study is right for your child and what the potential benefits and risks are. Participation involves your child receiving a specific breathing adjustment maneuver, while others receive standard care. Day-to-day involvement will depend on your child's condition and treatment, but will focus on monitoring breathing and heart function. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07193719 signal from an investment perspective?
This trial focuses on a niche but critical area of pediatric critical care, with potential to improve outcomes for vulnerable patients and reduce healthcare resource utilization. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participation involves adjusting breathing machine settings to find the best lung volume for each child. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.