Comparison of Oxygenation Index and Oxygen Stretch Index

NCT ID: NCT06586411

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-05
• Study Completion Date: 2025-10-30

Brief 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

Pediatric Acute Respiratory Distress Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PARDS

pediatric patients who were diagnosed with PARDS

No interventions assigned to this group

Eligibility 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%

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Medical AG

INDUSTRY

Sponsor Role: collaborator

Dr. Behcet Uz Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hasan ağın

Prof.Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hasan Agin

Role: STUDY_CHAIR

Dr. Behcet Uz Children's Hospital

Locations

Aydin Obstetric and pediatrics Hospital

Aydin, , Turkey (Türkiye)

Erzurum Regional Research and Training Hospital

Erzurum, , Turkey (Türkiye)

Cam Sakura Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Acibadem University, Acibadem Altunizade Hospital

Istanbul, , Turkey (Türkiye)

Istanbul Aydin University

Istanbul, , Turkey (Türkiye)

The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital

Izmir, , Turkey (Türkiye)

The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

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Other Identifiers

02021/519

Identifier Type: -

Identifier Source: org_study_id