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

Respiratory Distress Syndrome, Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06430619
• Other study ID #: 2024-40
• Status: Completed
• Start date: June 1, 2012
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2024
• Source: Basaksehir Çam & Sakura City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: May 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Locations

Country	Name	City	State
Turkey	Basaksehir Cam Sakura City Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Basaksehir Çam & Sakura City Hospital	SBÜ Dr. Sadi Konuk Egitim ve Arastirma Hastanesi

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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, — View Citation

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. — View Citation

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. — View Citation

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: — View Citation

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. — View Citation

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 ventilati — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During 28 days in the intensive care unit
Secondary	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.	During 28 days in the intensive care unit
Secondary	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.	During 28 days in the intensive care unit
Secondary	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.	During 28 days in the intensive care unit
Secondary	Other parameters	It was aimed to compare the Charlson comorbidity index of the patients.	During 28 days in the intensive care unit
Secondary	arterial blood gas parameters	It was aimed to compare the pH of the patients.	During 28 days in the intensive care unit
Secondary	arterial blood gas parameters	It was aimed to compare the base excess of the patients.	During 28 days in the intensive care unit
Secondary	arterial blood gas parameters	It was aimed to compare the lactate of the patients.	During 28 days in the intensive care unit
Secondary	arterial blood gas parameters	It was aimed to compare the partial oxygen pressure of the patients.	During 28 days in the intensive care unit