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

NCT ID: NCT06430619

Last Updated: 2024-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-01

Study Completion Date

2024-05-01

Brief Summary

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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

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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

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Respiratory Distress Syndrome, Adult

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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

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

No interventions assigned to this group

Eligibility Criteria

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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 Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

OTHER

Sponsor Role collaborator

Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Furkan Tontu

Doctor of Anesthesiology and Reanimation

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Basaksehir Cam Sakura City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 28823812 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30096809 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25693014 (View on PubMed)

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.

Reference Type RESULT
PMID: 22797452 (View on PubMed)

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.

Reference Type RESULT
PMID: 26903337 (View on PubMed)

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.

Reference Type RESULT
PMID: 33879214 (View on PubMed)

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.

Reference Type RESULT
PMID: 30291378 (View on PubMed)

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 Jun;39(6):595-608. doi: 10.1177/08850666231223498. Epub 2024 Jan 5.

Reference Type RESULT
PMID: 38179691 (View on PubMed)

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.

Reference Type RESULT
PMID: 27620287 (View on PubMed)

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.

Reference Type RESULT
PMID: 31931417 (View on PubMed)

Other Identifiers

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2024-40

Identifier Type: -

Identifier Source: org_study_id

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