Interstitial Lung Disease Clinical Trial
— O2LUSSUOfficial title:
"Correlation Between PaO2/FiO2 and Lung Ultrasound Score in Patients Admitted to an Intensive Care Unit With Interstitial Syndrome: A Prospective Physiological Study"
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.
Status | Recruiting |
Enrollment | 86 |
Est. completion date | December 30, 2024 |
Est. primary completion date | November 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 17 Years and older |
Eligibility | Inclusion Criteria: - consent ->17 years old Exclusion Criteria: - LUSS < 2 Non Inclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques universitaires saint luc | Brussel | |
Belgium | Centres Hospitaliers de Jolimont | Haine-Saint-Paul | Hainaut |
Lead Sponsor | Collaborator |
---|---|
Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
Belgium,
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* Note: There are 34 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Evolution | To assess the evolution of the correlation between the PaO2/FiO2 and the LUSS at inclusion, twenty-four hours, and forty-eight hours after inclusion in patients admitted in an ICU with IS. | Twenty four and forty eight hours | |
Secondary | Lung Ultrasound Score and SOFA score | to assess the presence of a correlation between LUSS and the SOFA score at inclusion, twenty-four et forty-eight hours of inclusion in patient admitted to an ICU with IS. | Inclusion,twenty four and forty eight hours | |
Secondary | Influence SOFA on the correlation between PaO2/FiO2 and LUSS | To determine the influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with IS. | Inclusion,twenty four and forty eight hours | |
Secondary | Pleural Effusions | To to determine the influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with IS. | Inclusion, twenty four and forty eight hours | |
Secondary | Correlation PaO2/FiO2 and the LUSS according to IS diagnosis | To assess the correlation between the PaO2/FiO2 and the LUSS in patients admitted in an ICU with IS According to the aetiologic diagnosis attributed to the IS (pulmonary oedema, bacterial or viral infection, post operative reactionary hypoventilation)
The end point of this secondary outcome considers the null hypothesis to be an improvement of 0,214 of the correlation between PaO2/FiO2 and LUSS |
Inclusion | |
Secondary | Correlation between the PaO2/FiO2 and the LUSS admission diagnosis | To assess the correlation between the PaO2/FiO2 and the LUSS in patients admitted in an ICU with IS according to admission diagnosis (cardiogenic shock, sepsis, infection, post operative) | Inclusion | |
Secondary | Correlation between the PaO2/FiO2 and the LUSS according to the LUSS value | To assess the correlation between the PaO2/FiO2 and the LUSS in patients admitted in an ICU with IS according to LUSS value (between two and six and between seven and thirty-six) The end point of this secondary outcome considers a negative linear distribution for PaO2/FiO2 and LUSS values | Inclusion | |
Secondary | Correlation between the PaO2/FiO2 and LUSS according to hypoxemia | To assess the correlation between the PaO2/FiO2 and the LUSS in patients admitted in an ICU with IS acordiing on hypoxemia severity based on PaO2/FiO2 as defined for ARDS3 (mild hypoxemia with PaO2/FiO2 between three hundred and two hundred, moderate hypoxemia with PaO2/FiO2 between one hundred and two hundred and severe hypoxemia with a PaO2/FiO2 of less than one hundred) | Inclusion | |
Secondary | Correlation between the PaO2/FiO2 and LUSS according to the RR at admission | To assess the correlation between the PaO2/FiO2 and the LUSS in patients admitted in an ICU with IS according to Respiratory Rate (RR) (low RR of less than twelve per minute, normal RR between twelve and twenty and elevated RR of more than twenty) | Inclusion | |
Secondary | Evolution of the correlation between the PaO2/FiO2 and the LUSS according to IS diagnosis | To assess the evolution of the correlation between the PaO2/FiO2 and the LUSS at inclusion, twenty-four hours, and forty-eight hours after inclusion in patients admitted in an ICU with IS According to the aetiologic diagnosis attributed to the IS (pulmonary oedema, bacterial or viral infection, post operative reactionary hypoventilation) a negative linear distribution for PaO2/FiO2 and LUSS values | Twenty four and forty eight hours | |
Secondary | Evolution of the correlation between the PaO2/FiO2 and the LUSS according to admission diagnosis | To assess the evolution of the correlation between the PaO2/FiO2 and the LUSS at inclusion, twenty-four hours, and forty-eight hours after inclusion in patients admitted in an ICU with IS according to admission diagnosis (cardiogenic shock, sepsis, infection, post operative) | Twenty four and forty eight hours | |
Secondary | Evolution of the correlation between the PaO2/FiO2 and the LUSS according to LUSS value | To assess the evolution of the correlation between the PaO2/FiO2 and the LUSS at inclusion, twenty-four hours, and forty-eight hours after inclusion in patients admitted in an ICU with IS according to LUSS value (between two and six and between seven and thirty-six) | Twenty four and forty eight hours | |
Secondary | Evolution of the correlation between the PaO2/FiO2 and the LUSS according to hypoxemia severity | To assess the evolution of the correlation between the PaO2/FiO2 and the LUSS at inclusion, twenty-four hours, and forty-eight hours after inclusion in patients admitted in an ICU with IS acordiing on hypoxemia severity based on PaO2/FiO2 as defined for ARDS3 (mild hypoxemia with PaO2/FiO2 between three hundred and two hundred, moderate hypoxemia with PaO2/FiO2 between one hundred and two hundred and severe hypoxemia with a PaO2/FiO2 of less than one hundred) | Twenty four and forty eight hours | |
Secondary | Evolution of the correlation between the PaO2/FiO2 and the LUSS according RR | To assess the evolution of the correlation between the PaO2/FiO2 and the LUSS at inclusion, twenty-four hours, and forty-eight hours after inclusion in patients admitted in an ICU with IS according to Respiratory Rate (RR) (low RR of less than twelve per minute, normal RR between twelve and twenty and elevated RR of more than twenty) | Twenty four and forty eight hours | |
Secondary | Correlation between LUSS and the SOFA score at inclusion according to the diagnosis of the IS | To assess the presence of a correlation between LUSS and the SOFA score at inclusion, twenty-four et forty-eight hours of inclusion in patient admitted to an ICU with IS According to the aetiologic diagnosis attributed to the IS (pulmonary oedema, bacterial or viral infection, post operative reactionary hypoventilation) The end point of this secondary outcome considers a positive linear correlation between LUSS and SOFA score and a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the SOFA score | Inclusion,twenty four and forty eight hours | |
Secondary | Correlation between LUSS and the SOFA score at inclusion according to admission diagnosis | to assess the presence of a correlation between LUSS and the SOFA score at inclusion, twenty-four et forty-eight hours of inclusion in patient admitted to an ICU with IS according to admission diagnosis (cardiogenic shock, sepsis, infection, post operative) The end point of this secondary outcome considers a positive linear correlation between LUSS and SOFA score and a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the SOFA score | Inclusion,twenty four and forty eight hours | |
Secondary | Correlation between LUSS and the SOFA score according to the LUSS value | to assess the presence of a correlation between LUSS and the SOFA score at inclusion, twenty-four et forty-eight hours of inclusion in patient admitted to an ICU with IS according to LUSS value (between two and six and between seven and thirty-six) The end point of this secondary outcome considers a positive linear correlation between LUSS and SOFA score and a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the SOFA score | Inclusion,twenty four and forty eight hours | |
Secondary | Correlation between LUSS and the SOFA score according to hypoxemia severity | to assess the presence of a correlation between LUSS and the SOFA score at inclusion, twenty-four et forty-eight hours of inclusion in patient admitted to an ICU with IS acordiing on hypoxemia severity based on PaO2/FiO2 as defined for ARDS3 (mild hypoxemia with PaO2/FiO2 between three hundred and two hundred, moderate hypoxemia with PaO2/FiO2 between one hundred and two hundred and severe hypoxemia with a PaO2/FiO2 of less than one hundred) The end point of this secondary outcome considers a positive linear correlation between LUSS and SOFA score and a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the SOFA score | Inclusion,twenty four and forty eight hours | |
Secondary | Correlation between LUSS and the SOFA score according to the RR | to assess the presence of a correlation between LUSS and the SOFA score at inclusion, twenty-four et forty-eight hours of inclusion in patient admitted to an ICU with IS according to Respiratory Rate (RR) (low RR of less than twelve per minute, normal RR between twelve and twenty and elevated RR of more than twenty) The end point of this secondary outcome considers a positive linear correlation between LUSS and SOFA score and a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the SOFA score | Inclusion,twenty four and forty eight hours | |
Secondary | Influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS according to IS diagnosis | To determine the influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with IS According to the aetiologic diagnosis attributed to the IS (pulmonary oedema, bacterial or viral infection, post operative reactionary hypoventilation) The end point of this secondary outcome considers a positive linear correlation between LUSS and SOFA score and a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the SOFA score | Inclusion,twenty four and forty eight hours | |
Secondary | Influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS according to admission diagnosis | To determine the influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with ISaccording to admission diagnosis (cardiogenic shock, sepsis, infection, post operative) The end point of this secondary outcome considers a positive linear correlation between LUSS and SOFA score and a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the SOFA score | Inclusion,twenty four and forty eight hours | |
Secondary | Influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS according to LUSS value | To determine the influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with IS according to LUSS value (between two and six and between seven and thirty-six) The end point of this secondary outcome considers a positive linear correlation between LUSS and SOFA score and a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the SOFA score | Inclusion,twenty four and forty eight hours | |
Secondary | Influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS according to hypoxemia severity | To determine the influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with IS acordiing on hypoxemia severity based on PaO2/FiO2 as defined for ARDS3 (mild hypoxemia with PaO2/FiO2 between three hundred and two hundred, moderate hypoxemia with PaO2/FiO2 between one hundred and two hundred and severe hypoxemia with a PaO2/FiO2 of less than one hundred) The end point of this secondary outcome considers a positive linear correlation between LUSS and SOFA score and a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the SOFA score | Inclusion,twenty four and forty eight hours | |
Secondary | Influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS according to RR | To determine the influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with IS.according to Respiratory Rate (RR) (low RR of less than twelve per minute, normal RR between twelve and twenty and elevated RR of more than twenty) The end point of this secondary outcome considers a positive linear correlation between LUSS and SOFA score and a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the SOFA score | Inclusion,twenty four and forty eight hours | |
Secondary | Influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS according to IS diagnosis | To determine the influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with IS According to the aetiologic diagnosis attributed to the IS (pulmonary oedema, bacterial or viral infection, post operative reactionary hypoventilation) The end point of this secondary outcome considers a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the presence of pleural effusions and pleural effusions' size. | Inclusion,twenty four and forty eight hours | |
Secondary | Influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS according to admission diagnosis | To determine the influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with IS according to admission diagnosis (cardiogenic shock, sepsis, infection, post operative) The end point of this secondary outcome considers a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the presence of pleural effusions and pleural effusions' size. | Inclusion,twenty four and forty eight hours | |
Secondary | Influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS according to LUSS value | To determine the influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with IS according to LUSS value (between two and six and between seven and thirty-six) The end point of this secondary outcome considers a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the presence of pleural effusions and pleural effusions' size. | Inclusion,twenty four and forty eight hours | |
Secondary | Influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS according to hypoxemia severity | To determine the influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with IS acordiing to hypoxemia severity based on PaO2/FiO2 as defined for ARDS3 (mild hypoxemia with PaO2/FiO2 between three hundred and two hundred, moderate hypoxemia with PaO2/FiO2 between one hundred and two hundred and severe hypoxemia with a PaO2/FiO2 of less than one hundred) The end point of this secondary outcome considers a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the presence of pleural effusions and pleural effusions' size. | Inclusion,twenty four and forty eight hours | |
Secondary | Influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS according to RR | To the influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS at inclusion, twenty-four et forty-eight hours of inclusion in patients admitted to an ICU with IS according to Respiratory Rate (RR) (low RR of less than twelve per minute, normal RR between twelve and twenty and elevated RR of more than twenty)
The end point of this secondary outcome considers a negative linear distribution for the correlation between PaO2/FiO2 and LUSS corrected by the presence of pleural effusions and pleural effusions' size. |
Inclusion,twenty four and forty eight hours |
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