NCT04813900

Brief Summary

The primary objective of this study is to assess the presence of a correlation between the Lung ultrasound score (LUSS) and PaO2/FiO2 in patient presenting with interstitial syndrome (IS) in the ED. The primary end point considers the null hypothesis to be a negative linear distribution for LUSS and PaO2/FiO2 values. Secondary objectives and secondary end points One of the secondary objectives is to assess the correlation between the LUSS and PaCO2 in patient presenting with IS in the ED. The end point of this secondary outcome considers the null hypothesis to be a positive linear distribution for the LUSS and PaCO2 values. Another secondary objective is to determine the influence of the presence of unilateral or bilateral pleural effusion on the correlation between LUSS and PaO2/FiO2. The end point of this secondary outcome considers the null hypothesis to be a negative linear distribution for LUSS and PaO2/FiO in those three sub-groups: absence of pleural effusion group, unilateral pleural effusion group and bilateral pleural effusion group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

5 months

First QC Date

March 19, 2021

Last Update Submit

January 17, 2022

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

  • The primary objective of this study is to assess the presence of a correlation between the LUSS and PaO2/FiO2 in patient presenting with IS in the ED

    The primary end point considers the null hypothesis to be a negative linear distribution for LUSS and PaO2/FiO2 values.

    6 months

Secondary Outcomes (2)

  • correlation between the LUSS and PaCO2 in patient presenting with IS in the ED

    6 months

  • influence of the presence of unilateral or bilateral pleural effusion on the correlation between LUSS and PaO2/FiO2

    6 months

Study Arms (1)

Patient suspected to suffer from interstitial syndrome needing an arterial blood gas analysis

EXPERIMENTAL
Other: Lung ultrasound

Interventions

Lung ultrasoundOTHER

Lung ultrasound in order to calculate lung ultrasound score

Patient suspected to suffer from interstitial syndrome needing an arterial blood gas analysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed consent
  • \>17 years old
  • Arterial Blood Gas analysis at admission
  • Lung ultrasound within 10 minutes of ABG sample

You may not qualify if:

  • Patient with pathologies leading to chronic interstitial syndrome
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Lung ultrasound not feasible: pneumonectomy history, severe obesity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires saint luc

Brussels, 1200, Belgium

Location

Related Publications (16)

  • 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: 16984837RESULT

  • 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: 22392031RESULT

  • 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: 29466596RESULT

  • 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: 21925058RESULT

  • 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: 30372119RESULT

  • 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: 9372688RESULT

  • Lichtenstein DA, Meziere GA, Lagoueyte JF, Biderman P, Goldstein I, Gepner A. A-lines and B-lines: lung ultrasound as a bedside tool for predicting pulmonary artery occlusion pressure in the critically ill. Chest. 2009 Oct;136(4):1014-1020. doi: 10.1378/chest.09-0001.

    PMID: 19809049RESULT

  • 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: 19168766RESULT

  • 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: 15888847RESULT

  • 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: 15135701RESULT

  • Bellani G, Rouby JJ, Constantin JM, Pesenti A. Looking closer at acute respiratory distress syndrome: the role of advanced imaging techniques. Curr Opin Crit Care. 2017 Feb;23(1):30-37. doi: 10.1097/MCC.0000000000000380.

    PMID: 27906709RESULT

  • 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: 20221746RESULT

  • 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: 19633538RESULT

  • 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: 20851923RESULT

  • 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: 22584759RESULT

  • 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: 26298866RESULT

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, MD Consultant in Emergency Medicine

Study Record Dates

First Submitted

March 19, 2021

First Posted

March 24, 2021

Study Start

April 1, 2021

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

January 19, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)