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Correlation Between Lung UltraSound Score and Hypoxemia for Interstitial Syndrome in Emergency Department (O2LUSS)

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ClinicalTrials.gov Identifier: NCT04813900
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Dupriez Florence, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.


Condition or disease Intervention/treatment Phase
Interstitial Lung Disease Other: Lung ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 161 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Correlation Between Lung UltraSound Score and Hypoxemia for Interstitial Syndrome in Emergency Department
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Patient suspected to suffer from interstitial syndrome needing an arterial blood gas analysis Other: Lung ultrasound
Lung ultrasound in order to calculate lung ultrasound score




Primary Outcome Measures :
  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 [ Time Frame: 6 months ]
    The primary end point considers the null hypothesis to be a negative linear distribution for LUSS and PaO2/FiO2 values.


Secondary Outcome Measures :
  1. correlation between the LUSS and PaCO2 in patient presenting with IS in the ED [ Time Frame: 6 months ]
    The end point of this secondary outcome considers the null hypothesis to be a positive linear distribution for the LUSS and PaCO2 values.

  2. influence of the presence of unilateral or bilateral pleural effusion on the correlation between LUSS and PaO2/FiO2 [ Time Frame: 6 months ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04813900


Contacts
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Contact: Florence Dupriez, MD +32 476692812 florence.dupriez@uclouvain.be

Locations
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Belgium
Cliniques universitaires saint luc Recruiting
Brussel, Belgium, 1200
Contact: Florence Dupriez, MD         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Publications of Results:

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Responsible Party: Dupriez Florence, Principal investigator, MD Consultant in Emergency Medicine, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT04813900    
Other Study ID Numbers: 2021/10FEV/062
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Emergencies
Hypoxia
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Signs and Symptoms, Respiratory