"Correlation Between PaO2/FiO2 and Lung Ultrasound Score in Patients Admitted to an Intensive Care Unit With Interstitial Syndrome"

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05631756
Collaborator
(none)
78
2
1
8
39
4.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Lung Ultrasound
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
"Correlation Between PaO2/FiO2 and Lung Ultrasound Score in Patients Admitted to an Intensive Care Unit With Interstitial Syndrome: A Prospective Physiological Study"
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patient Population

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

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

Outcome Measures

Primary Outcome Measures

  1. Correlation PaO2/FiO2 and LUSS [At inclusion]

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

Secondary Outcome Measures

  1. Evolution [Twenty four and forty eight hours]

    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.

  2. Lung Ultrasound Score and SOFA score [Inclusion,twenty four and forty eight hours]

    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.

  3. Influence SOFA on the correlation between PaO2/FiO2 and LUSS [Inclusion,twenty four and forty eight hours]

    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.

  4. Pleural Effusions [Inclusion, twenty four and forty eight hours]

    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.

  5. Correlation PaO2/FiO2 and the LUSS according to IS diagnosis [Inclusion]

    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

  6. Correlation between the PaO2/FiO2 and the LUSS admission diagnosis [Inclusion]

    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)

  7. Correlation between the PaO2/FiO2 and the LUSS according to the LUSS value [Inclusion]

    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

  8. Correlation between the PaO2/FiO2 and LUSS according to hypoxemia [Inclusion]

    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)

  9. Correlation between the PaO2/FiO2 and LUSS according to the RR at admission [Inclusion]

    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)

  10. Evolution of the correlation between the PaO2/FiO2 and the LUSS according to IS diagnosis [Twenty four and forty eight hours]

    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

  11. Evolution of the correlation between the PaO2/FiO2 and the LUSS according to admission diagnosis [Twenty four and forty eight hours]

    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)

  12. Evolution of the correlation between the PaO2/FiO2 and the LUSS according to LUSS value [Twenty four and forty eight hours]

    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)

  13. Evolution of the correlation between the PaO2/FiO2 and the LUSS according to hypoxemia severity [Twenty four and forty eight hours]

    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)

  14. Evolution of the correlation between the PaO2/FiO2 and the LUSS according RR [Twenty four and forty eight hours]

    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)

  15. Correlation between LUSS and the SOFA score at inclusion according to the diagnosis of the IS [Inclusion,twenty four and forty eight hours]

    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

  16. Correlation between LUSS and the SOFA score at inclusion according to admission diagnosis [Inclusion,twenty four and forty eight hours]

    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

  17. Correlation between LUSS and the SOFA score according to the LUSS value [Inclusion,twenty four and forty eight hours]

    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

  18. Correlation between LUSS and the SOFA score according to hypoxemia severity [Inclusion,twenty four and forty eight hours]

    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

  19. Correlation between LUSS and the SOFA score according to the RR [Inclusion,twenty four and forty eight hours]

    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

  20. Influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS according to IS diagnosis [Inclusion,twenty four and forty eight hours]

    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

  21. Influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS according to admission diagnosis [Inclusion,twenty four and forty eight hours]

    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

  22. Influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS according to LUSS value [Inclusion,twenty four and forty eight hours]

    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

  23. Influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS according to hypoxemia severity [Inclusion,twenty four and forty eight hours]

    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

  24. Influence of the SOFA score on the correlation between PaO2/FiO2 and LUSS according to RR [Inclusion,twenty four and forty eight hours]

    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

  25. Influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS according to IS diagnosis [Inclusion,twenty four and forty eight hours]

    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.

  26. Influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS according to admission diagnosis [Inclusion,twenty four and forty eight hours]

    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.

  27. Influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS according to LUSS value [Inclusion,twenty four and forty eight hours]

    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.

  28. Influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS according to hypoxemia severity [Inclusion,twenty four and forty eight hours]

    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.

  29. Influence of the presence and size of pleural effusions on the correlation between PaO2/FiO2 and LUSS according to RR [Inclusion,twenty four and forty eight hours]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centres Hospitaliers de Jolimont Haine-Saint-Paul Hainaut Belgium 7100
2 Cliniques universitaires saint luc Brussel Belgium 1200

Sponsors and Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT05631756
Other Study ID Numbers:
  • O2LUSSICU
First Posted:
Nov 30, 2022
Last Update Posted:
Nov 30, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 30, 2022