Comparing two methods for assessing lung function in children with respiratory distress
Comparison of Oxygenation Index and Oxygen Stretch Index With Mechanical Power, Driving Pressure, Transpulmonary Pressure, and Lung Ultrasound Scores in PARDS Patients
Dr. Behcet Uz Children's Hospital · NCT06586411
This study is trying to see if a new way of measuring lung function can help doctors better understand and treat children with serious breathing problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 1 Month to 18 Years |
| Sex | All |
| Sponsor | Dr. Behcet Uz Children's Hospital (other) |
| Locations | 7 sites (Aydın and 6 other locations) |
| Trial ID | NCT06586411 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the Oxygenation Index (OI) and the Oxygen Stretch Index in pediatric patients diagnosed with Acute Respiratory Distress Syndrome (pARDS). It will evaluate various parameters such as transpulmonary pressure, mechanical power, and lung ultrasound scores to assess lung injury severity. The study seeks to determine if using driving pressure in the oxygenation index formula provides a better evaluation of pARDS compared to traditional methods. By analyzing these metrics, the study hopes to improve the understanding and management of respiratory failure in children.
Who should consider this trial
Good fit: Ideal candidates for this study are intubated pediatric patients diagnosed with pARDS.
Not a fit: Patients with perinatal lung disease, cardiac failure, or those whose respiratory mechanics cannot be measured will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and treatment strategies for pediatric patients suffering from acute respiratory distress syndrome.
How similar studies have performed: Other studies have shown success in using similar approaches to assess lung injury in both adult and pediatric populations, indicating potential for this method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * pARDS patient * Intubated patient Exclusion Criteria: * Perinatal lung disease * Cardiac failure and fluid overload * Patients whose respiratory mechanics cannot be measured * Age under 1 month or above 18 years old * ETT leakage \> 18%
Where this trial is running
Aydın and 6 other locations
- Aydin Obstetric and pediatrics Hospital — Aydın, Turkey (RECRUITING)
- Erzurum Regional Research and Training Hospital — Erzurum, Turkey (RECRUITING)
- Cam Sakura Research and Training Hospital — Istanbul, Turkey (RECRUITING)
- Acibadem University, Acibadem Altunizade Hospital — Istanbul, Turkey (RECRUITING)
- Istanbul Aydin University — Istanbul, Turkey (COMPLETED)
- The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital — Izmir, Turkey (RECRUITING)
- The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital — İzmir, Turkey (RECRUITING)
Study contacts
- Study coordinator: Hasan Agin
- Email: Hasanagin@gmail.com
- Phone: +905362013162
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.
Conditions: Pediatric Acute Respiratory Distress Syndrome, Acute respiratory failure, Oxygenation index, Transpulmonary pressure, Mechanical power, Oxygen stretch index, Driving pressure, Lung ultrasound