Clinical Trials Directory

Trials / Completed

CompletedNCT06586411

Comparison of Oxygenation Index and Oxygen Stretch Index

Comparison of Oxygenation Index and Oxygen Stretch Index With Mechanical Power, Driving Pressure, Transpulmonary Pressure, and Lung Ultrasound Scores in PARDS Patients

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
Dr. Behcet Uz Children's Hospital · Academic / Other
Sex
All
Age
1 Month – 18 Years
Healthy volunteers
Not accepted

Summary

Pediatric acute respiratory distress syndrome (pARDS) is a heterogeneous clinical syndrome that causes high rates of mortality and morbidity. The Pediatric Acute Lung Injury Consensus Conference (PALICC) guideline recommends using the oxygenation index (OI = mean airway pressure (MAP) × FiO2 /PaO2) for the diagnosis and classification of pediatric ARDS. Driving pressure (DP) is calculated by subtracting PEEP from plateau pressure. It is an important determinant of tidal volume in each breath and indirectly reflects lung stress. It is the best parameter associated with mortality and lung injury in many studies. In the oxygenation index formula; adding driving pressure instead of Pmean may be more useful in evaluating the severity of pARDS. In our study, we will compare the Oxygenation Stress Index with OI in patients with pARDS. We will compare transpulmonary pressure, mechanical power, lung ultrasound score, and other respiratory mechanics, which are parameters indicating lung injury.

Detailed description

Pediatric acute respiratory distress syndrome (pARDS) is a heterogeneous clinical syndrome that causes high rates of mortality and morbidity. The Pediatric Acute Lung Injury Consensus Conference (PALICC) guideline recommends using the oxygenation index (OI = mean airway pressure (MAP) × FiO2 /PaO2) for the diagnosis and classification of pediatric ARDS. In recent years, studies conducted on adult and pediatric populations have emphasized ''driving pressure'' as the most important ventilator parameter associated with mortality. Driving pressure (DP) is calculated by subtracting PEEP from plateau pressure. It is an important determinant of tidal volume in each breath and indirectly reflects lung stress. Lung stress is directly measured with transpulmonary pressure (PL). Mechanical power (MP) is the amount of energy applied to patients per unit time and its relationship with lung injury has been shown in adult and pediatric studies. Another method that shows lung damage is measured noninvasively at the patient's bedside. It has been validated in many adult, pediatric, and neonatal studies. In an adult study, DP was used instead of MAP inspired by the oxygenation index and defined as the Oxygenation stretch index. It was emphasized that it can better predict oxygenation and mortality. OI is not used in the ARDS classification in adults. Adding airway pressure to the oxygenation equation is very important to standardize the severity of the disease. However, its effect on patient outcomes has not been determined as much as mean airway pressure, plateau, and driving pressure. In addition, no target recommendation has been presented in the PALICC guidelines. Plateau pressure is the end-inspiratory pressure and does not have a direct effect on PEEP. Since ventilator management is still heterogeneous in pediatric literature in line with the guidelines, it seems more logical to use driving pressure, which includes both inspiratory pressure and expiratory pressure. Within the framework of this information, adding driving pressure to the formula instead of Pmean (MAP) in the oxygenation index may be useful in evaluating both the severity of pARDS and the effectiveness of respiratory dynamics. In our study, we will compare the Oxygenation Stretch Index with OI in patients with pARDS. We will examine its effects on parameters indicating lung damage, respiratory mechanics and patient outcomes.

Conditions

Timeline

Start date
2024-11-05
Primary completion
2025-08-30
Completion
2025-10-30
First posted
2024-09-19
Last updated
2025-11-25

Locations

7 sites across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06586411. Inclusion in this directory is not an endorsement.