## Protocol Section
### Identification Module
**NCT ID:** NCT06430619

**Brief Title:** Can Novel Oxygenation Indices Guide the Diagnosis of Acute Respiratory Distress Syndrome

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

#### Organization Study ID Info
**ID:** 2024-40
#### Organization
**Class:** OTHER_GOV
**Full Name:** Başakşehir Çam & Sakura City Hospital
### Status Module
#### Completion Date
**Date:** 2024-05-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-02-01

**Type:** ACTUAL

#### Start Date
**Date:** 2012-06-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Başakşehir Çam & Sakura City Hospital

#### Responsible Party

**Investigator Affiliation:** Başakşehir Çam & Sakura City Hospital

**Investigator Full Name:** Furkan Tontu

**Investigator Title:** Doctor of Anesthesiology and Reanimation

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Respiratory Distress Syndrome, Adult

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 2000

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The oxygenation indexes of the patients will be measured and the effectiveness of these indexes in diagnosing ARDS will be compared.

**Label:** Patients diagnosed with Acute Respiratory Distress Syndrome (ARDS) according to Berlin criteria

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Oxygenation indices

**Time Frame:** During 28 days in the intensive care unit

#### Secondary Outcomes

**Description:** 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.

**Measure:** Other parameters

**Time Frame:** During 28 days in the intensive care unit

**Description:** 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.

**Measure:** acute physiology and chronic health evaluation-II

**Time Frame:** During 28 days in the intensive care unit

**Description:** 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.

**Measure:** Charlson comorbidity index scores

**Time Frame:** During 28 days in the intensive care unit

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

**Measure:** Other parameters

**Time Frame:** During 28 days in the intensive care unit

**Description:** It was aimed to compare the pH of the patients.

**Measure:** arterial blood gas parameters

**Time Frame:** During 28 days in the intensive care unit

**Description:** It was aimed to compare the base excess of the patients.

**Measure:** arterial blood gas parameters

**Time Frame:** During 28 days in the intensive care unit

**Description:** It was aimed to compare the lactate of the patients.

**Measure:** arterial blood gas parameters

**Time Frame:** During 28 days in the intensive care unit

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

**Measure:** arterial blood gas parameters

**Time Frame:** During 28 days in the intensive care unit

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients admitted to the intensive care unit of Istanbul Bakırköy Dr. Sadi Konuk Training and Research Hospital with a preliminary diagnosis of ARDS/C-ARDS between June 01, 2012, and February 01, 2024

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Istanbul

**Country:** Turkey

**Facility:** Basaksehir Cam Sakura City Hospital

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 28823812

**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.

**PMID:** 30096809

**Citation:** 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.

**PMID:** 25693014

**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.

**PMID:** 22797452

**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, 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.

**PMID:** 26903337

**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.

**PMID:** 33879214

**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 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.

**PMID:** 30291378

**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. doi: 10.1177/08850666231223498. Online ahead of print.

**PMID:** 38179691

**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: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.

**PMID:** 27620287

**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.

**PMID:** 31931417

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000012120

- Term: Respiration Disorders

- ID: D000007235

- Term: Infant, Premature, Diseases

- ID: D000007232

- Term: Infant, Newborn, Diseases

- ID: D000055370

- Term: Lung Injury

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M14965

- Name: Respiratory Distress Syndrome

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: M14964

- Name: Respiratory Distress Syndrome, Newborn

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: M28144

- Name: Acute Lung Injury

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome, Adult

- ID: M28143

- Name: Lung Injury

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M25869

- Name: Premature Birth

- Relevance: LOW

- As Found: Unknown

- ID: M10279

- Name: Infant, Premature, Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10276

- Name: Infant, Newborn, Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4927

- Name: Respiratory Distress Syndrome, Infant

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: T192

- Name: Acute Respiratory Distress Syndrome

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012128

- Term: Respiratory Distress Syndrome

- ID: D000012127

- Term: Respiratory Distress Syndrome, Newborn

- ID: D000055371

- Term: Acute Lung Injury

- ID: D000013577

- Term: Syndrome

### Misc Info Module

- Version Holder: 2024-05-31
