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Completed

NCT Number: NCT06430619

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Basaksehir Cam Sakura City Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Oxygenation indices

    Time frame: During 28 days in the intensive care unit

    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.

Secondary outcomes

  1. Other parameters

    Time frame: During 28 days in the intensive care unit

    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.

  2. acute physiology and chronic health evaluation-II

    Time frame: During 28 days in the intensive care unit

    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.

  3. Charlson comorbidity index scores

    Time frame: During 28 days in the intensive care unit

    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.

  4. Other parameters

    Time frame: During 28 days in the intensive care unit

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

  5. arterial blood gas parameters

    Time frame: During 28 days in the intensive care unit

    It was aimed to compare the pH of the patients.

  6. arterial blood gas parameters

    Time frame: During 28 days in the intensive care unit

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

  7. arterial blood gas parameters

    Time frame: During 28 days in the intensive care unit

    It was aimed to compare the lactate of the patients.

  8. arterial blood gas parameters

    Time frame: During 28 days in the intensive care unit

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

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Collaborators

  • SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Registry information

Official study title

New Criteria for Classifying Acute Respiratory Distress Syndrome Severity Using a Machine Learning Approach: Novel Oxygenation and Saturation Indices

Important dates

Study start
2012
Primary completion
2024
Study completion
2024
First posted
May 28, 2024
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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