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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06430619
Enrollment
2000
Registered
2024-05-28
Start date
2012-06-01
Completion date
2024-05-01
Last updated
2024-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Adult

Brief 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.

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.

Interventions

None listed

Sponsors

SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
CollaboratorOTHER
Başakşehir Çam & Sakura City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Design outcomes

Primary

MeasureTime frameDescription
Oxygenation indicesDuring 28 days in the intensive care unitIt was aimed to compare the oxygenation indexes of the patients. It will be examined which of these indices is more effective in diagnosing ARDS.

Secondary

MeasureTime frameDescription
Other parametersDuring 28 days in the intensive care unitIt was aimed to compare the sequential organ failure assessment scores of the patients. Score ranges from 0 (best outcome) to 24 (worst outcome) points.
acute physiology and chronic health evaluation-IIDuring 28 days in the intensive care unitIt 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.
Charlson comorbidity index scoresDuring 28 days in the intensive care unitIt 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.
arterial blood gas parametersDuring 28 days in the intensive care unitIt was aimed to compare the pH of the patients.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026