Comparison of Oxygenation Index and Oxygen Stretch Index

NCT06586411 | Completed DMC

• 1 other identifier: 02021/519
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 7

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.

Conditions

Pediatric Acute Respiratory Distress Syndrome

Keywords

Acute respiratory failure (ARF); Oxygenation index; Transpulmonary pressure; Mechanical power; Oxygen stretch index; Driving pressure; Lung ultrasound

Outcome Measures

Primary Outcomes (1)

• Correlation of Oxygenation Index and Oxygenation Stretch Index in Acute Pediatric Respiratory Distress Syndrome (pARDS) Patiens in the PICU

  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

Study Arms (1)

PARDS

pediatric patients who were diagnosed with PARDS

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Intubated pARDS patients in PICU

You may qualify if:

• pARDS patient
• Intubated patient

You may not qualify if:

• 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%

Sponsors & Collaborators

• Dr. Behcet Uz Children's Hospital: lead
• Hamilton Medical AG: collaborator

Study Sites (7)

Aydin Obstetric and pediatrics Hospital

Aydin, 09020, Turkey (Türkiye)

Location

Erzurum Regional Research and Training Hospital

Erzurum, 25180, Turkey (Türkiye)

Location

Cam Sakura Research and Training Hospital

Istanbul, 34001, Turkey (Türkiye)

Location

Acibadem University, Acibadem Altunizade Hospital

Istanbul, Turkey (Türkiye)

Location

Istanbul Aydin University

Istanbul, Turkey (Türkiye)

Location

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

Izmir, 35200, Turkey (Türkiye)

Location

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

Izmir, Turkey (Türkiye)

Location

Related Publications (12)

• van Schelven P, Koopman AA, Burgerhof JGM, Markhorst DG, Blokpoel RGT, Kneyber MCJ. Driving Pressure Is Associated With Outcome in Pediatric Acute Respiratory Failure. Pediatr Crit Care Med. 2022 Mar 1;23(3):e136-e144. doi: 10.1097/PCC.0000000000002848.

  PMID: 34669679 BACKGROUND

• Emeriaud G, Lopez-Fernandez YM, Iyer NP, Bembea MM, Agulnik A, Barbaro RP, Baudin F, Bhalla A, Brunow de Carvalho W, Carroll CL, Cheifetz IM, Chisti MJ, Cruces P, Curley MAQ, Dahmer MK, Dalton HJ, Erickson SJ, Essouri S, Fernandez A, Flori HR, Grunwell JR, Jouvet P, Killien EY, Kneyber MCJ, Kudchadkar SR, Korang SK, Lee JH, Macrae DJ, Maddux A, Modesto I Alapont V, Morrow BM, Nadkarni VM, Napolitano N, Newth CJL, Pons-Odena M, Quasney MW, Rajapreyar P, Rambaud J, Randolph AG, Rimensberger P, Rowan CM, Sanchez-Pinto LN, Sapru A, Sauthier M, Shein SL, Smith LS, Steffen K, Takeuchi M, Thomas NJ, Tse SM, Valentine S, Ward S, Watson RS, Yehya N, Zimmerman JJ, Khemani RG; Second Pediatric Acute Lung Injury Consensus Conference (PALICC-2) Group on behalf of the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Executive Summary of the Second International Guidelines for the Diagnosis and Management of Pediatric Acute Respiratory Distress Syndrome (PALICC-2). Pediatr Crit Care Med. 2023 Feb 1;24(2):143-168. doi: 10.1097/PCC.0000000000003147. Epub 2023 Jan 20.

  PMID: 36661420 BACKGROUND

• Chen L, Chen GQ, Shore K, Shklar O, Martins C, Devenyi B, Lindsay P, McPhail H, Lanys A, Soliman I, Tuma M, Kim M, Porretta K, Greco P, Every H, Hayes C, Baker A, Friedrich JO, Brochard L. Implementing a bedside assessment of respiratory mechanics in patients with acute respiratory distress syndrome. Crit Care. 2017 Apr 4;21(1):84. doi: 10.1186/s13054-017-1671-8.

  PMID: 28372575 BACKGROUND

• Chen L, Grieco DL, Beloncle F, Chen GQ, Tiribelli N, Madotto F, Fredes S, Lu C, Antonelli M, Mercat A, Slutsky AS, Zhou JX, Brochard L. Partition of respiratory mechanics in patients with acute respiratory distress syndrome and association with outcome: a multicentre clinical study. Intensive Care Med. 2022 Jul;48(7):888-898. doi: 10.1007/s00134-022-06724-y. Epub 2022 Jun 7.

  PMID: 35670818 BACKGROUND

• Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.

  PMID: 25693014 BACKGROUND

• Khemani RG, Smith LS, Zimmerman JJ, Erickson S; Pediatric Acute Lung Injury Consensus Conference Group. Pediatric acute respiratory distress syndrome: definition, incidence, and epidemiology: proceedings from the Pediatric Acute Lung Injury Consensus Conference. Pediatr Crit Care Med. 2015 Jun;16(5 Suppl 1):S23-40. doi: 10.1097/PCC.0000000000000432.

  PMID: 26035358 BACKGROUND

• Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22.

  PMID: 27334266 BACKGROUND

• Chiumello D, Chidini G, Calderini E, Colombo A, Crimella F, Brioni M. Respiratory mechanics and lung stress/strain in children with acute respiratory distress syndrome. Ann Intensive Care. 2016 Dec;6(1):11. doi: 10.1186/s13613-016-0113-0. Epub 2016 Feb 5.

  PMID: 26847436 BACKGROUND

• Vedrenne-Cloquet M, Khirani S, Khemani R, Lesage F, Oualha M, Renolleau S, Chiumello D, Demoule A, Fauroux B. Pleural and transpulmonary pressures to tailor protective ventilation in children. Thorax. 2023 Jan;78(1):97-105. doi: 10.1136/thorax-2021-218538. Epub 2022 Jul 8.

  PMID: 35803726 BACKGROUND

• Khemani RG, Smith L, Lopez-Fernandez YM, Kwok J, Morzov R, Klein MJ, Yehya N, Willson D, Kneyber MCJ, Lillie J, Fernandez A, Newth CJL, Jouvet P, Thomas NJ; Pediatric Acute Respiratory Distress syndrome Incidence and Epidemiology (PARDIE) Investigators; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Paediatric acute respiratory distress syndrome incidence and epidemiology (PARDIE): an international, observational study. Lancet Respir Med. 2019 Feb;7(2):115-128. doi: 10.1016/S2213-2600(18)30344-8. Epub 2018 Oct 22.

  PMID: 30361119 BACKGROUND

• Mojoli F, Torriglia F, Orlando A, Bianchi I, Arisi E, Pozzi M. Technical aspects of bedside respiratory monitoring of transpulmonary pressure. Ann Transl Med. 2018 Oct;6(19):377. doi: 10.21037/atm.2018.08.37.

  PMID: 30460251 BACKGROUND

• Ceylan G, Topal S, Atakul G, Colak M, Soydan E, Sandal O, Sari F, Agin H. Randomized crossover trial to compare driving pressures in a closed-loop and a conventional mechanical ventilation mode in pediatric patients. Pediatr Pulmonol. 2021 Sep;56(9):3035-3043. doi: 10.1002/ppul.25561. Epub 2021 Jul 22.

  PMID: 34293255 BACKGROUND

Study Officials

• Hasan Agin

  Dr. Behcet Uz Children's Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: November 5, 2024
• Primary Completion: August 30, 2025
• Study Completion: October 30, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (7)