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CompletedNCT06430619Updated May 28, 2024

Can Novel Oxygenation Indices Guide the Diagnosis of Acute Respiratory Distress Syndrome

An observational study in Respiratory Distress Syndrome, Adult, sponsored by Başakşehir Çam & Sakura City Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-28.

Sponsored by Başakşehir Çam & Sakura City Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to determine the cut-off values of the new oxygenation indices and further investigate their capabilities in diagnosing ARDS and predicting its severity in ICU. Additionally, the investigators aim to compare these results with conventional oxygenation and saturation indices.

Read the detailed description

Recent studies have shown that mechanical power (MP) values below 17 J/min and driving pressure (DP) values below 15 cmH2O reduce intensive care unit (ICU) mortality. Asar et al. have introduced six new oxygenation indices utilizing MP and DP instead of Pmean (OSI-MPtot, OI-MPtot, OSI-ΔPinsp, OI-ΔPinsp, OSI-MPdyn, OI-MPdyn). They compared the predictive abilities of these new indices for ICU mortality in Covid-ARDS (C-ARDS) patients with conventional oxygenation indices (P/F, SpO2/FiO2, OI, OSI, PaO2/(FiO2xPEEP), and SpO2/FiO2xPEEP). OI-ΔPinsp, OSI-ΔPinsp, and OSI-MPdyn indices exhibited the highest predictive power for ICU mortality. However, cut-off values for the diagnosis and severity determination (mild, moderate, and severe) of ARDS patients have not been investigated.

In this study, our objective is to determine the cut-off values of the new oxygenation indices and further investigate their capabilities in diagnosing ARDS and predicting its severity in ICU. Additionally, the investigators aim to compare these results with conventional oxygenation and saturation indices.

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Conditions studied

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In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 2,000 is above the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Başakşehir Çam & Sakura City Hospital is the lead sponsor of 105 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients admitted to the intensive care unit of Istanbul Bakırköy Dr. Sadi Konuk Training and Research Hospital with a preliminary diagnosis of ARDS/C-ARDS between June 01, 2012, and February 01, 2024

Inclusion criteria

  1. Patients admitted to intensive care units diagnosed with ARDS / C-ARDS according to the Berlin criteria.
  2. Adult patients aged between 18 and 80 years

Exclusion criteria

Exclusion Criteria:

  1. Patients under the age of 18
  2. Pregnant patients
  3. Patients without ARDS
  4. Patients with missing data
  5. Patients transferred to another hospital
  6. Patients discharged from the ICU within 72 hours
  7. Patients receiving extracorporeal membrane oxygenation (ECMO) support.
  8. Patients were on mechanical ventilation for less than 24 hours
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
2,000 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients diagnosed with Acute Respiratory Distress Syndrome (ARDS) according to Berlin criteria

    The oxygenation indexes of the patients will be measured and the effectiveness of these indexes in diagnosing ARDS will be compared.

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What researchers measure

Primary outcomes

  1. Oxygenation indices

    It was aimed to compare the oxygenation indexes of the patients. It will be examined which of these indices is more effective in diagnosing ARDS.

    Time frame: During 28 days in the intensive care unit

Secondary outcomes

  1. Other parameters

    It was aimed to compare the sequential organ failure assessment scores of the patients. Score ranges from 0 (best outcome) to 24 (worst outcome) points.

    Time frame: During 28 days in the intensive care unit

  2. acute physiology and chronic health evaluation-II

    It was aimed to compare the acute physiology and chronic health evaluation-II scores of the patients. Score ranges from 0 (best outcome) to 71 (worst outcome) points.

    Time frame: During 28 days in the intensive care unit

  3. Charlson comorbidity index scores

    It was aimed to compare the Charlson comorbidity index scores of the patients. Based on the Charlson comorbidity index score, the severity of comorbidity was categorized into three grades: mild, with Charlson comorbidity index scores of 1-2; moderate, with Charlson comorbidity index scores of 3-4; and severe, with Charlson comorbidity index scores ≥5.

    Time frame: During 28 days in the intensive care unit

  4. Other parameters

    It was aimed to compare the Charlson comorbidity index of the patients.

    Time frame: During 28 days in the intensive care unit

  5. arterial blood gas parameters

    It was aimed to compare the pH of the patients.

    Time frame: During 28 days in the intensive care unit

  6. arterial blood gas parameters

    It was aimed to compare the base excess of the patients.

    Time frame: During 28 days in the intensive care unit

  7. arterial blood gas parameters

    It was aimed to compare the lactate of the patients.

    Time frame: During 28 days in the intensive care unit

  8. arterial blood gas parameters

    It was aimed to compare the partial oxygen pressure of the patients.

    Time frame: During 28 days in the intensive care unit

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Study locations

1 site
  • Basaksehir Cam Sakura City Hospital
    Istanbul, Turkey
08

References and documents

Publications

  • DesPrez K, McNeil JB, Wang C, Bastarache JA, Shaver CM, Ware LB. Oxygenation Saturation Index Predicts Clinical Outcomes in ARDS. Chest. 2017 Dec;152(6):1151-1158. doi: 10.1016/j.chest.2017.08.002. Epub 2017 Aug 16. Erratum In: Chest. 2018 Mar;153(3):768. doi: 10.1016/j.chest.2018.01.010. PubMed 28823812 ↗
  • Chen WL, Lin WT, Kung SC, Lai CC, Chao CM. The Value of Oxygenation Saturation Index in Predicting the Outcomes of Patients with Acute Respiratory Distress Syndrome. J Clin Med. 2018 Aug 8;7(8):205. doi: 10.3390/jcm7080205. PubMed 30096809 ↗
  • 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. PubMed 25693014 ↗
  • ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669. PubMed 22797452 ↗
  • Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum In: JAMA. 2016 Jul 19;316(3):350. doi: 10.1001/jama.2016.6956. JAMA. 2016 Jul 19;316(3):350. doi: 10.1001/jama.2016.9558. PubMed 26903337 ↗
  • Sayed M, Riano D, Villar J. Novel criteria to classify ARDS severity using a machine learning approach. Crit Care. 2021 Apr 20;25(1):150. doi: 10.1186/s13054-021-03566-w. PubMed 33879214 ↗
  • Serpa Neto A, Deliberato RO, Johnson AEW, Bos LD, Amorim P, Pereira SM, Cazati DC, Cordioli RL, Correa TD, Pollard TJ, Schettino GPP, Timenetsky KT, Celi LA, Pelosi P, Gama de Abreu M, Schultz MJ; PROVE Network Investigators. Mechanical power of ventilation is associated with mortality in critically ill patients: an analysis of patients in two observational cohorts. Intensive Care Med. 2018 Nov;44(11):1914-1922. doi: 10.1007/s00134-018-5375-6. Epub 2018 Oct 5. PubMed 30291378 ↗
  • Asar S, Rahim F, Rahimi P, Acicbe O, Tontu F, Cukurova Z. Novel Oxygenation and Saturation Indices for Mortality Prediction in COVID-19 ARDS Patients: The Impact of Driving Pressure and Mechanical Power. J Intensive Care Med. 2024 Jun;39(6):595-608. doi: 10.1177/08850666231223498. Epub 2024 Jan 5. PubMed 38179691 ↗
  • Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12. PubMed 27620287 ↗
  • Asar S, Acicbe O, Cukurova Z, Hergunsel GO, Canan E, Cakar N. Bedside dynamic calculation of mechanical power: A validation study. J Crit Care. 2020 Apr;56:167-170. doi: 10.1016/j.jcrc.2019.12.027. Epub 2020 Jan 2. PubMed 31931417 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06430619
Lead sponsor
Başakşehir Çam & Sakura City Hospital
Collaborators
SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
Responsible party
Furkan Tontu (Doctor of Anesthesiology and Reanimation, Başakşehir Çam & Sakura City Hospital) — Principal investigator
First posted
May 28, 2024
Start date
Jun 1, 2012
Primary completion
Feb 1, 2024
Completion
May 1, 2024
Last update
May 28, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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