Comparison of Oxygenation Index and Oxygen Stretch Index

November 22, 2025 updated by: Hasan ağın, Dr. Behcet Uz Children's Hospital

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Aydin, Turkey (Türkiye), 09020
        • Aydin Obstetric and pediatrics Hospital
      • Erzurum, Turkey (Türkiye), 25180
        • Erzurum Regional Research and Training Hospital
      • Istanbul, Turkey (Türkiye), 34001
        • Cam Sakura Research and Training Hospital
      • Istanbul, Turkey (Türkiye)
        • Acibadem University, Acibadem Altunizade Hospital
      • Istanbul, Turkey (Türkiye)
        • Istanbul Aydin University
      • Izmir, Turkey (Türkiye)
        • The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital
      • Izmir, Turkey (Türkiye), 35200
        • The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Intubated pARDS patients in PICU

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
PARDS
pediatric patients who were diagnosed with PARDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of Oxygenation Index and Oxygenation Stretch Index in Acute Pediatric Respiratory Distress Syndrome (pARDS) Patiens in the PICU
Time Frame: 2 hours
By comparing the oxygenation stress index with the oxygenation index; it will be investigated whether it is a better parameter indicating lung damage. For this purpose, Oxygenation index and oxygenation stretch index will be correlated with mechanical power. Oxygenation index and oxygenation stretch index will be correlated with lung ultrasound score. Oxygenation index and oxygenation stretch index will be correlated with driving pressure. Oxygenation index and oxygenation stretch index will be correlated with transpulmonary pressure. Oxygenation index and oxygenation stretch index will be correlated with transpulmonary driving pressure.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Behcet Uz Children's Hospital

Collaborators

Hamilton Medical AG

Investigators

  • Study Chair: Hasan Agin, Dr. Behcet Uz Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2024

Primary Completion (Actual)

August 30, 2025

Study Completion (Actual)

October 30, 2025

Study Registration Dates

First Submitted

September 4, 2024

First Submitted That Met QC Criteria

September 4, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 22, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02021/519

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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