- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06430619
Can Novel Oxygenation Indices Guide the Diagnosis of Acute Respiratory Distress Syndrome
New Criteria for Classifying Acute Respiratory Distress Syndrome Severity Using a Machine Learning Approach: Novel Oxygenation and Saturation Indices
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Basaksehir Cam Sakura City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients admitted to intensive care units diagnosed with ARDS / C-ARDS according to the Berlin criteria.
- Adult patients aged between 18 and 80 years
Exclusion Criteria:
- Patients under the age of 18
- Pregnant patients
- Patients without ARDS
- Patients with missing data
- Patients transferred to another hospital
- Patients discharged from the ICU within 72 hours
- Patients receiving extracorporeal membrane oxygenation (ECMO) support.
- Patients were on mechanical ventilation for less than 24 hours
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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 is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Oxygenation indices
Time Frame: During 28 days in the intensive care unit
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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.
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During 28 days in the intensive care unit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Other parameters
Time Frame: During 28 days in the intensive care unit
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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. |
During 28 days in the intensive care unit
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acute physiology and chronic health evaluation-II
Time Frame: During 28 days in the intensive care unit
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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. |
During 28 days in the intensive care unit
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Charlson comorbidity index scores
Time Frame: During 28 days in the intensive care unit
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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.
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During 28 days in the intensive care unit
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Other parameters
Time Frame: During 28 days in the intensive care unit
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It was aimed to compare the Charlson comorbidity index of the patients.
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During 28 days in the intensive care unit
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arterial blood gas parameters
Time Frame: During 28 days in the intensive care unit
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It was aimed to compare the pH of the patients.
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During 28 days in the intensive care unit
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arterial blood gas parameters
Time Frame: During 28 days in the intensive care unit
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It was aimed to compare the base excess of the patients.
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During 28 days in the intensive care unit
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arterial blood gas parameters
Time Frame: During 28 days in the intensive care unit
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It was aimed to compare the lactate of the patients.
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During 28 days in the intensive care unit
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arterial blood gas parameters
Time Frame: During 28 days in the intensive care unit
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It was aimed to compare the partial oxygen pressure of the patients.
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During 28 days in the intensive care unit
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Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- 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. JAMA. 2016 Jul 19;316(3):350.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 Jan 5:8850666231223498. doi: 10.1177/08850666231223498. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-40
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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