Clinical trial NCT06586411: Comparison of Oxygenation Index and Oxygen Stretch Index
Official title: Comparison of Oxygenation Index and Oxygen Stretch Index With Mechanical Power, Driving Pressure, Transpulmonary Pressure, and Lung Ultrasound Scores in PARDS Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric Acute Respiratory Distress Syndrome
Keywords: Acute respiratory failure (ARF)
Oxygenation index
Transpulmonary pressure
Mechanical power
Oxygen stretch index
Driving pressure
Lung ultrasound
Lead sponsor: Dr. Behcet Uz Children's Hospital
Sponsor class: OTHER
Collaborators: name: Hamilton Medical AG
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intubated pARDS patients in PICU

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.

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%

Primary outcomes:
measure: Correlation of Oxygenation Index and Oxygenation Stretch Index in Acute Pediatric Respiratory Distress Syndrome (pARDS) Patiens in the PICU
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Aydin Obstetric and pediatrics Hospital
city: Erzurum
country: Turkey
facility: Erzurum Regional Research and Training Hospital
city: Istanbul
country: Turkey
facility: Cam Sakura Research and Training Hospital
city: Istanbul
country: Turkey
facility: Acibadem University, Acibadem Altunizade Hospital
city: Istanbul
country: Turkey
facility: Istanbul Aydin University
city: Izmir
country: Turkey
facility: The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital
city: İzmir
country: Turkey
facility: The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital
Study officials:
affiliation: Dr. Behcet Uz Children's Hospital
name: Hasan Agin
role: STUDY_CHAIR
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