Correlation Between PaO2/FiO2 and Lung Ultrasound Score in the Intensive Care Unit

NCT05631756 | Completed

• 1 other identifier: 2022/24NOV/444
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this physiological interventional prospective study is to evaluate the improvement of the previously demonstrated correlation between PaO2/ FiO2 and Lung Ultrasound score (LUSS) in patients admitted in the ICU with an intesrtitial syndrom (IS) on the ultrasound of all aetiologies at inclusion and at twenty four and forty eight hours. The main question it aims to answer is if the LUSS is a valid tool to evaluate the severity of the IS Participants will initially have an arterial blood gas to evaluate the PaO2/FiO2 and in the ten minutes a lung ultrasound to evaluate the LUSS. This will be repeated at twenty four and forty eight hours.

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

• Correlation PaO2/FiO2 and LUSS

  To assess the correlation between the PaO2/FiO2 and the LUSS in patients admitted in an ICU with IS.

  At inclusion

Secondary Outcomes (29)

• Evolution

  Twenty four and forty eight hours

• Lung Ultrasound Score and SOFA score

  Inclusion,twenty four and forty eight hours

• Influence SOFA on the correlation between PaO2/FiO2 and LUSS

  Inclusion,twenty four and forty eight hours

• Pleural Effusions

  Inclusion, twenty four and forty eight hours

• Correlation PaO2/FiO2 and the LUSS according to IS diagnosis

  Inclusion

Study Arms (1)

Patient Population

EXPERIMENTAL

All patients included in the study, meaning patients in the ICU presenting an interstitial syndrom no matter the aetiology

Other: Lung Ultrasound

Interventions

Lung Ultrasound OTHER

Evaluation of the Lung Ultrasound Score in patients presenting an interstitial syndrom on the lung ultrasound and to compare it with PaO2/FiO2

Patient Population

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- consent
• \>17 years old

You may not qualify if:

• LUSS \< 2
• Patient with pathologies leading to chronic IS
• Chronic Obstructive Pulmonary Disease (COPD) or active asthma
• Patients under veino-veinous or veino-arterial " Extracorporeal Membrane Oxygenation " (ECMO)
• Severe trauma patients
• Less than twenty-four hours post operative patients
• LUS not feasible: prone position, pneumonectomy history, severe obesity

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (2)

Cliniques universitaires saint luc

Brussels, Brussels Capital, 1200, Belgium

Location

Centres Hospitaliers de Jolimont

Haine-Saint-Paul, Hainaut, 7100, Belgium

Location

Related Publications (34)

• Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. doi: 10.1016/j.ajem.2006.02.013.

  PMID: 16984837 BACKGROUND

• Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.

  PMID: 22392031 BACKGROUND

• 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 BACKGROUND

• Lichtenstein D, Meziere G, Biderman P, Gepner A, Barre O. The comet-tail artifact. An ultrasound sign of alveolar-interstitial syndrome. Am J Respir Crit Care Med. 1997 Nov;156(5):1640-6. doi: 10.1164/ajrccm.156.5.96-07096.

  PMID: 9372688 BACKGROUND

• Mojoli F, Bouhemad B, Mongodi S, Lichtenstein D. Lung Ultrasound for Critically Ill Patients. Am J Respir Crit Care Med. 2019 Mar 15;199(6):701-714. doi: 10.1164/rccm.201802-0236CI.

  PMID: 30372119 BACKGROUND

• Zieleskiewicz L, Cornesse A, Hammad E, Haddam M, Brun C, Vigne C, Meyssignac B, Remacle A, Chaumoitre K, Antonini F, Martin C, Leone M. Implementation of lung ultrasound in polyvalent intensive care unit: Impact on irradiation and medical cost. Anaesth Crit Care Pain Med. 2015 Feb;34(1):41-4. doi: 10.1016/j.accpm.2015.01.002. Epub 2015 Mar 5.

  PMID: 25829314 BACKGROUND

• Brogi E, Bignami E, Sidoti A, Shawar M, Gargani L, Vetrugno L, Volpicelli G, Forfori F. Could the use of bedside lung ultrasound reduce the number of chest x-rays in the intensive care unit? Cardiovasc Ultrasound. 2017 Sep 13;15(1):23. doi: 10.1186/s12947-017-0113-8.

  PMID: 28903756 BACKGROUND

• Lichtenstein D, Goldstein I, Mourgeon E, Cluzel P, Grenier P, Rouby JJ. Comparative diagnostic performances of auscultation, chest radiography, and lung ultrasonography in acute respiratory distress syndrome. Anesthesiology. 2004 Jan;100(1):9-15. doi: 10.1097/00000542-200401000-00006.

  PMID: 14695718 BACKGROUND

• Agricola E, Bove T, Oppizzi M, Marino G, Zangrillo A, Margonato A, Picano E. "Ultrasound comet-tail images": a marker of pulmonary edema: a comparative study with wedge pressure and extravascular lung water. Chest. 2005 May;127(5):1690-5. doi: 10.1378/chest.127.5.1690.

  PMID: 15888847 BACKGROUND

• Soldati G, Copetti R, Sher S. Sonographic interstitial syndrome: the sound of lung water. J Ultrasound Med. 2009 Feb;28(2):163-74. doi: 10.7863/jum.2009.28.2.163.

  PMID: 19168766 BACKGROUND

• Jambrik Z, Monti S, Coppola V, Agricola E, Mottola G, Miniati M, Picano E. Usefulness of ultrasound lung comets as a nonradiologic sign of extravascular lung water. Am J Cardiol. 2004 May 15;93(10):1265-70. doi: 10.1016/j.amjcard.2004.02.012.

  PMID: 15135701 BACKGROUND

• Ziskin MC, Thickman DI, Goldenberg NJ, Lapayowker MS, Becker JM. The comet tail artifact. J Ultrasound Med. 1982 Jan-Feb;1(1):1-7. doi: 10.7863/jum.1982.1.1.1.

  PMID: 6152918 BACKGROUND

• Yue Lee FC, Jenssen C, Dietrich CF. A common misunderstanding in lung ultrasound: the comet tail artefact. Med Ultrason. 2018 Aug 30;20(3):379-384. doi: 10.11152/mu-1573.

  PMID: 30167593 BACKGROUND

• Minana G, Nunez J, Banuls P, Sanchis J, Nunez E, Robles R, Mascarell B, Palau P, Chorro FJ, Llacer A. Prognostic implications of arterial blood gases in acute decompensated heart failure. Eur J Intern Med. 2011 Oct;22(5):489-94. doi: 10.1016/j.ejim.2011.01.014. Epub 2011 Feb 25.

  PMID: 21925058 BACKGROUND

• Gupta B, Jain G, Chandrakar S, Gupta N, Agarwal A. Arterial Blood Gas as a Predictor of Mortality in COVID Pneumonia Patients Initiated on Noninvasive Mechanical Ventilation: A Retrospective Analysis. Indian J Crit Care Med. 2021 Aug;25(8):866-871. doi: 10.5005/jp-journals-10071-23917.

  PMID: 34733025 BACKGROUND

• Fan E, Brodie D, Slutsky AS. Acute Respiratory Distress Syndrome: Advances in Diagnosis and Treatment. JAMA. 2018 Feb 20;319(7):698-710. doi: 10.1001/jama.2017.21907.

  PMID: 29466596 BACKGROUND

• Via G, Lichtenstein D, Mojoli F, Rodi G, Neri L, Storti E, Klersy C, Iotti G, Braschi A. Whole lung lavage: a unique model for ultrasound assessment of lung aeration changes. Intensive Care Med. 2010 Jun;36(6):999-1007. doi: 10.1007/s00134-010-1834-4. Epub 2010 Mar 11.

  PMID: 20221746 BACKGROUND

• Zhao Z, Jiang L, Xi X, Jiang Q, Zhu B, Wang M, Xing J, Zhang D. Prognostic value of extravascular lung water assessed with lung ultrasound score by chest sonography in patients with acute respiratory distress syndrome. BMC Pulm Med. 2015 Aug 23;15:98. doi: 10.1186/s12890-015-0091-2.

  PMID: 26298866 BACKGROUND

• Bouhemad B, Liu ZH, Arbelot C, Zhang M, Ferarri F, Le-Guen M, Girard M, Lu Q, Rouby JJ. Ultrasound assessment of antibiotic-induced pulmonary reaeration in ventilator-associated pneumonia. Crit Care Med. 2010 Jan;38(1):84-92. doi: 10.1097/CCM.0b013e3181b08cdb.

  PMID: 19633538 BACKGROUND

• Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. doi: 10.1164/rccm.201003-0369OC. Epub 2010 Sep 17.

  PMID: 20851923 BACKGROUND

• Soummer A, Perbet S, Brisson H, Arbelot C, Constantin JM, Lu Q, Rouby JJ; Lung Ultrasound Study Group. Ultrasound assessment of lung aeration loss during a successful weaning trial predicts postextubation distress*. Crit Care Med. 2012 Jul;40(7):2064-72. doi: 10.1097/CCM.0b013e31824e68ae.

  PMID: 22584759 BACKGROUND

• Pisani L, Vercesi V, van Tongeren PSI, Lagrand WK, Leopold SJ, Huson MAM, Henwood PC, Walden A, Smit MR, Riviello ED, Pelosi P, Dondorp AM, Schultz MJ; Lung Ultrasound Consortium. The diagnostic accuracy for ARDS of global versus regional lung ultrasound scores - a post hoc analysis of an observational study in invasively ventilated ICU patients. Intensive Care Med Exp. 2019 Jul 25;7(Suppl 1):44. doi: 10.1186/s40635-019-0241-6.

  PMID: 31346914 BACKGROUND

• Song G, Qiao W, Wang X, Yu X. Association of Lung Ultrasound Score with Mortality and Severity of COVID-19: A Meta-Analysis and Trial Sequential Analysis. Int J Infect Dis. 2021 Jul;108:603-609. doi: 10.1016/j.ijid.2021.06.026. Epub 2021 Jun 17.

  PMID: 34146693 BACKGROUND

• Peach RJ, Day WA, Ellingsen PJ, McGiven AR. Ultrastructural localization of Tamm-Horsfall protein in human kidney using immunogold electron microscopy. Histochem J. 1988 Mar;20(3):156-64. doi: 10.1007/BF01746679.

  PMID: 3410739 BACKGROUND

• Todur P; Souvik Chaudhuri FNB Critical Care; Vedaghosh Amara FNB Critical Care; Srikant N, Prakash P. Correlation of Oxygenation and Radiographic Assessment of Lung Edema (RALE) Score to Lung Ultrasound Score (LUS) in Acute Respiratory Distress Syndrome (ARDS) Patients in the Intensive Care Unit. Can J Respir Ther. 2021 May 19;57:53-59. doi: 10.29390/cjrt-2020-063. eCollection 2021.

  PMID: 34041358 BACKGROUND

• Li L, Yao Y, Liu S. The Value of Pulmonary Bedside Ultrasound System in the Evaluation of Severity and Prognosis of Acute Lung Injury. Comput Math Methods Med. 2022 Jan 27;2022:6471437. doi: 10.1155/2022/6471437. eCollection 2022.

  PMID: 35126630 BACKGROUND

• Vasseur E, Moureau G, Fasseaux A, Peyskens L, Gendebien F, Thys F, Dupriez F. Correlation between hypoxaemia and lung ultrasound score in patients presenting to an emergency department with interstitial syndrome: a prospective physiological study. Crit Care Resusc. 2023 Oct 18;24(3):233-241. doi: 10.51893/2022.3.OA2. eCollection 2022 Sep 5.

  PMID: 38046212 BACKGROUND

• Lambden S, Laterre PF, Levy MM, Francois B. The SOFA score-development, utility and challenges of accurate assessment in clinical trials. Crit Care. 2019 Nov 27;23(1):374. doi: 10.1186/s13054-019-2663-7.

  PMID: 31775846 BACKGROUND

• Li L, Yang Q, Li L, Guan J, Liu Z, Han J, Chao Y, Wang Z, Yu X. [The value of lung ultrasound score on evaluating clinical severity and prognosis in patients with acute respiratory distress syndrome]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2015 Jul;27(7):579-84. doi: 10.3760/cma.j.issn.2095-4352.2015.07.008. Chinese.

  PMID: 26138420 BACKGROUND

• Brogi E, Gargani L, Bignami E, Barbariol F, Marra A, Forfori F, Vetrugno L. Thoracic ultrasound for pleural effusion in the intensive care unit: a narrative review from diagnosis to treatment. Crit Care. 2017 Dec 28;21(1):325. doi: 10.1186/s13054-017-1897-5.

  PMID: 29282107 BACKGROUND

• Vignon P, Chastagner C, Berkane V, Chardac E, Francois B, Normand S, Bonnivard M, Clavel M, Pichon N, Preux PM, Maubon A, Gastinne H. Quantitative assessment of pleural effusion in critically ill patients by means of ultrasonography. Crit Care Med. 2005 Aug;33(8):1757-63. doi: 10.1097/01.ccm.0000171532.02639.08.

  PMID: 16096453 BACKGROUND

• Roch A, Bojan M, Michelet P, Romain F, Bregeon F, Papazian L, Auffray JP. Usefulness of ultrasonography in predicting pleural effusions > 500 mL in patients receiving mechanical ventilation. Chest. 2005 Jan;127(1):224-32. doi: 10.1378/chest.127.1.224.

  PMID: 15653988 BACKGROUND

• Balik M, Plasil P, Waldauf P, Pazout J, Fric M, Otahal M, Pachl J. Ultrasound estimation of volume of pleural fluid in mechanically ventilated patients. Intensive Care Med. 2006 Feb;32(2):318. doi: 10.1007/s00134-005-0024-2. Epub 2006 Jan 24.

  PMID: 16432674 BACKGROUND

• Remerand F, Dellamonica J, Mao Z, Ferrari F, Bouhemad B, Jianxin Y, Arbelot C, Lu Q, Ichai C, Rouby JJ. Multiplane ultrasound approach to quantify pleural effusion at the bedside. Intensive Care Med. 2010 Apr;36(4):656-64. doi: 10.1007/s00134-010-1769-9. Epub 2010 Feb 6.

  PMID: 20140421 BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Eleonore Vasseur, MD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: November 30, 2022
• Study Start: January 26, 2023
• Primary Completion: May 13, 2025
• Study Completion: May 13, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)