Personalized ventilation strategies for children with respiratory distress
REcruitment MAneuvers and Mechanical Ventilation Guided by EIT in Pediatric Acute Respiratory Distress Syndrome (pARDS)
This study tests a new way to help children with breathing problems by using special technology to personalize their ventilation settings for better oxygen delivery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 13 (estimated) |
| Ages | 1 Month to 5 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06067152 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of electrical impedance tomography (EIT) to guide mechanical ventilation strategies in children diagnosed with pediatric Acute Respiratory Distress Syndrome (pARDS). The approach involves stepwise recruitment maneuvers tailored to individual lung morphology, aiming to optimize oxygenation and ventilation. By assessing the unique characteristics of each patient's lung condition, the study seeks to implement a more personalized and effective ventilation strategy. Participants will undergo EIT measurements and adjustments to their ventilation settings based on real-time data.
Who should consider this trial
Good fit: Ideal candidates are intubated and mechanically ventilated children aged 1 month to 5 years who meet the criteria for pARDS.
Not a fit: Patients with previous barotrauma, signs of intracranial hypertension, or certain congenital heart diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved oxygenation and outcomes for children suffering from pARDS.
How similar studies have performed: Previous studies in adult populations have shown success with similar personalized ventilation approaches, suggesting potential applicability in pediatric cases.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Intubated and mechanically ventilated children, ageing 1 months-5 years and meeting the PALICC definition for pediatric Acute Respiratory Distress Syndrome (pARDS) * Informed Consent signed Exclusion Criteria: Patients with one or more of the following characteristics: * Previous barotrauma (pneumothorax, pneumomediastinum or subcutaneous emphysema) * Signs of intracranial hypertension * Cyanotic congenital cardiac disease * Dorso-lumbar pathologies or other bone pathologies associated with restrictive lung disease (such as scoliosis, kyphosis) * Implantable devices not compatible with EIT (such as pace-makers and implantable cardioverter defibrillator) * Controindication to positioning the esophageal catheter (surgery, esophageal stenosis)
Where this trial is running
Milan
- Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico Milano — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Giovanna Chidini, MD — Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Study coordinator: Giovanna Chidini, MD
- Email: giovanna.chidini@policlinico.mi.it
- Phone: 0255032242
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.