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

Completed

• Conditions: Respiratory Distress Syndrome, Adult

• Registration Number: NCT06430619
• Lead Sponsor: Başakşehir Çam & Sakura City Hospital

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.

Study Timeline

• Study Start: 2012-06-01
• Primary Completion: 2024-02-01
• Status Verified: 2024-05
• Study Completion: 2024-05-01
• Study First Submitted: 2024-05-09
• Study First Submitted QC: 2024-05-21
• Last Update Submitted: 2024-05-21
• Study First Posted: 2024-05-28
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oxygenation indices	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 Outcome Measures

Name	Time	Method
arterial blood gas parameters	During 28 days in the intensive care unit	It was aimed to compare the partial oxygen pressure of the patients.
acute physiology and chronic health evaluation-II	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.
Other parameters	During 28 days in the intensive care unit	It was aimed to compare the Charlson comorbidity index of the patients.
Charlson comorbidity index scores	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.

Trial Locations

Locations (1)

Basaksehir Cam Sakura City Hospital; 🇹🇷 Istanbul, Turkey