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NCT Number: NCT06650137

Evaluation of the Relevance of Diaphragmatic Stroke Ultrasound for the Etiological Diagnosis of Acute Respiratory Distress in an Emergency Department.

The goal of this Prospective interventional multicenter diagnostic study is to investigate the use of diaphragmatic ultrasound (DE) as a diagnostic tool in an adult emergency department for patients in acute respiratory distress.

The main question it aims to answer is to evaluate the relevance of measuring the Sum of Plateau Times (SPT) by Clinical Ultrasound in Emergency Medicine (CHEM) for the diagnosis of pneumopathy during acute respiratory distress (ARD) in the Emergency Department.

Secondary objectives include the study of other diaphragmatic ultrasound parameters, inspiratory plateau time (IPT) and expiratory plateau time (EPT), and the diagnostic relevance of PTS for the diagnosis of decompensation of Chronic obstructive pulmonary disease (BPCO) and acute cardiogenic pulmonary edema (APO).

Each eligible patient will have a right diaphragmatic ultrasound performed by a trained physician, then clinicobiological data will be collected later from medical records, and the etiological diagnosis will be established by a committee of 2 experts in the management of respiratory distress.

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Key information

Conditions

Pneumonia Acute Respiratory Distress Syndrome (ARDS) Diaphragm; Movement Diaphragmatic Ultrasound Disease Attributes Emergencies Emergency Medical Services Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Nîmes, Nîmes, Gard, France

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About this study

Diaphragmatic ultrasound (DE) has never been studied as a diagnostic tool in the emergency department. The sensitivity and specificity of pleural ultrasound for the diagnosis of pneumopathy is superior to that of chest radiography, with evidence of interstitial syndrome or unilateral pleural effusion, but it is not specific for infectious pneumopathy. Proving that diaphragmatic ultrasonography can be used to diagnose pneumopathy in respiratory distress, thanks to a specific index known as the Sum of Plateau Times (STP), will save time in patient management.

The secondary criteria of this study could be used in future studies, if they prove relevant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18 years of age or older;
  • Patient with ARD defined by respiratory rate (RR) strictly superior to 25 and/or signs of struggle which are: thoraco-abdominal rocking, active abdominal breathing, recruitment of extra-diaphragmatic respiratory muscles AND
  • peripheral saturation (SpO2) strictly inferior to 90% and/or hypercapnic acidosis (pH strictly inferior to 7.35 and pCO2 strictly superior to 45mmHg) on arterial blood gases;
  • Spontaneous ventilation.
  • Patients presenting a clinical severity score of Grade 1 with signs of struggle, as well as those with Grade 2 and Grade 3. A clinical severity score will be used as follows: Grade 1: Minimal polypnoea with respiratory rate (RR) between 20 and 25 ; Grade 2: Moderate polypnoea with respiratory rate (RR) between 25 and 35; Grade 3: Major polypnoea with respiratory rate (RR) between 35 to 50.

Exclusion criteria

  • Adult protected by law (guardianship, curatorship, legal protection)
  • Refusal of consent after information
  • Patient on non-invasive ventilation ;
  • Patient on mechanical ventilation;
  • Respiratory rate superior to 50/min
  • Patient currently being treated for infectious pneumopathy with antibiotics;
  • Pregnant or breast-feeding women;
  • Patients with any known history of diaphragmatic pathologies.
  • Illiterate or unable to understand the purpose and methodology of the study.
  • Patient not affiliated to a social security scheme or not benefiting from such a scheme.
  • Person deprived of liberty (by judicial or administrative decision, or forced hospitalization)
  • Person participating in another study with an exclusion period still in progress,

Treatment and study plan

Diaphragmatic Ultrasound

Diagnostic Test

The examination is performed with a phased array probe, also known as a cardiac probe. The technique used will be that described and validated in anterior studies: the patient is in the Fowler position: half-seated, at an angle of around 45 degrees. The patient is ventilating spontaneously, and no participation is required. The probe is positioned in the sub-costal region between the mid-clavicular and anterior axillary line on the right, and between the anterior and middle axillary line in the sub- or intercostal region on the left. The liver is used as an acoustic window for the right hemi-diaphragm. The probe is oriented medially, cranially and dorsally.

The operator switches to time-motion (TM) mode when an angle of over 70° is achieved between the upper part of the diaphragm and the analysis axis in the most cephalic part of the diaphragm. The image is frozen when 6 respiratory cycles have been measured.

Primary outcomes

  1. Assess the relevance of Sum of plateau times (STP) measurement by diaphragmatic ultrasound for the diagnosis of pneumopathy during acute respiratory distress (ARD) in an emergency department. (Specificity)

    Time frame: Baseline

    STP (in seconds) is a sum of inspiratory plateau time (IPT) and expiratory plateau time (TPE) measured in seconds.

    TPE is defined as the time between the end of diaphragmatic descent and the start of its ascent, measured by recording Diaphragmatic curves (DC).

    TPI is defined as the time between the end of diaphragmatic ascent and the start of its descent.

    These measurements will be carried out after the ultrasound on the diaphragmatic movements recorded.

    The diagnosis will be established on the basis of medical records by two independent experts.

    intrinsic diagnostic performance will be analyzed by specificity in percentage.

    specificity corresponds to the probability of STP of giving a negative diagnosis of pneumopathy among participants without pneumopathy according to expert review of medical records (gold standard)

  2. Assess the relevance of Sum of plateau times (STP) measurement by diaphragmatic ultrasound for the diagnosis of pneumopathy during acute respiratory distress (ARD) in an emergency department. (sensibility)

    Time frame: Baseline

    STP (in seconds) is a sum of inspiratory plateau time (IPT) and expiratory plateau time (TPE) measured in seconds.

    TPE is defined as the time between the end of diaphragmatic descent and the start of its ascent, measured by recording Diaphragmatic curves (DC).

    TPI is defined as the time between the end of diaphragmatic ascent and the start of its descent.

    These measurements will be carried out after the ultrasound on the diaphragmatic movements recorded.

    The diagnosis will be established on the basis of medical records by two independent experts.

    intrinsic diagnostic performance will be analyzed by sensibility in percentage.

    sensitivity corresponds to the probability of STP of giving a positive diagnosis of pneumopathy among participants with pneumopathy based on expert review of medical records (gold standard).

  3. Assess the relevance of Sum of plateau times (STP) measurement by diaphragmatic ultrasound for the diagnosis of pneumopathy during acute respiratory distress (ARD) in an emergency department. (Positive predictive values)

    Time frame: Baseline

    STP is a sum of inspiratory plateau time (IPT) and expiratory plateau time (TPE) measured in seconds.

    TPE is defined as the time between the end of diaphragmatic descent and the start of its ascent, measured by recording Diaphragmatic curves (DC).

    TPI is defined as the time between the end of diaphragmatic ascent and the start of its descent.

    These measurements will be carried out after the ultrasound on the diaphragmatic movements recorded.

    The diagnosis will be established on the basis of medical records by two independent experts.

    Extrinsic diagnostic performance will be analyzed by Positive predictive values (PPV) in percentage.

    PPV corresponds to the probability of having pneumopathy if the PTS detects pneumopathy among participants with pneumopathy according to expert review of medical records (gold standard).

  4. Assess the relevance of Sum of plateau times (STP) measurement by diaphragmatic ultrasound for the diagnosis of pneumopathy during acute respiratory distress (ARD) in an emergency department. (Negative predictive values)

    Time frame: Baseline

    STP is a sum of inspiratory plateau time (IPT) and expiratory plateau time (TPE) measured in seconds.

    TPE is defined as the time between the end of diaphragmatic descent and the start of its ascent, measured by recording Diaphragmatic curves (DC).

    TPI is defined as the time between the end of diaphragmatic ascent and the start of its descent.

    These measurements will be carried out after the ultrasound on the diaphragmatic movements recorded.

    Extrinsic diagnostic performance will be analyzed by Negative predictive values (NPV) in percentage.

    NPV corresponds to the probability of not having pneumopathy if the PTS does not detect pneumopathy among participants without pneumopathy according to the expert review of medical records (gold standard).

  5. Assess the relevance of Sum of plateau times (STP) measurement by diaphragmatic ultrasound for the diagnosis of pneumopathy during acute respiratory distress (ARD) in an emergency department. (Positive likelihood ratio)

    Time frame: Baseline

    STP is a sum of inspiratory plateau time (IPT) and expiratory plateau time (TPE) measured in seconds.

    TPE is defined as the time between the end of diaphragmatic descent and the start of its ascent, measured by recording Diaphragmatic curves (DC).

    TPI is defined as the time between the end of diaphragmatic ascent and the start of its descent.

    These measurements will be carried out after the ultrasound on the diaphragmatic movements recorded.

    The diagnosis will be established on the basis of medical records by two independent experts.

    Extrinsic diagnostic performance will be analyzed by Positive likelihood ratio (PLR) in percentage. it is the ratio of true positives to false positives

  6. Assess the relevance of Sum of plateau times (STP) measurement by diaphragmatic ultrasound for the diagnosis of pneumopathy during acute respiratory distress (ARD) in an emergency department. (Negative likelihood ratio)

    Time frame: Baseline

    STP is a sum of inspiratory plateau time (IPT) and expiratory plateau time (TPE) measured in seconds.

    TPE is defined as the time between the end of diaphragmatic descent and the start of its ascent, measured by recording Diaphragmatic curves (DC).

    TPI is defined as the time between the end of diaphragmatic ascent and the start of its descent.

    These measurements will be carried out after the ultrasound on the diaphragmatic movements recorded.

    Extrinsic diagnostic performance will be analyzed by Negative likelihood ratio (PLR) in percentage. It is the ratio of false negatives to true negatives

Secondary outcomes

  1. Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (Sensibility)

    Time frame: Baseline

    Sensibility %

  2. Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (Specificity)

    Time frame: Baseline

    Specificity %

  3. Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (Positive predictive values (%))

    Time frame: Baseline

    Positive predictive values (%)

  4. Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (Negative predictive values (%))

    Time frame: Baseline

    Negative predictive values (%)

  5. Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (Positive likelihood ratio (%))

    Time frame: Baseline

    Positive likelihood ratio (%)

  6. Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (Negative likelihood ratio (%))

    Time frame: Baseline

    Negative likelihood ratio (%)

  7. Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department (Sensibility )

    Time frame: Baseline

    Sensibility %

  8. Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency departmentSpecificity

    Time frame: Baseline

    Specificity %

  9. Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. Negative predictive values

    Time frame: Baseline

    Negative predictive values %

  10. Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. Positive likelihood ratio

    Time frame: Baseline

    Positive likelihood ratio %

  11. Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. Negative likelihood ratio

    Time frame: Baseline

    Negative likelihood ratio %

  12. Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Sensibility

    Time frame: Baseline

    Sensibility %

  13. Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Specificity

    Time frame: Baseline

    Specificity %

  14. Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive predictive values

    Time frame: Baseline

    Positive predictive values %

  15. Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative predictive values

    Time frame: Baseline

    Negative predictive values %

  16. Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive likelihood ratio

    Time frame: Baseline

    Positive likelihood ratio %

  17. Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative likelihood ratio

    Time frame: Baseline

    Negative likelihood ratio %

  18. Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Sensibility

    Time frame: Baseline

    Sensibility %

  19. Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Specificity

    Time frame: Baseline

    Specificity %

  20. Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive predictive values

    Time frame: Baseline

    Positive predictive values %

  21. Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative predictive values

    Time frame: Baseline

    Negative predictive values %

  22. Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive likelihood ratio

    Time frame: Baseline

    Positive likelihood ratio %

  23. Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative likelihood ratio

    Time frame: Baseline

    Negative likelihood ratio %

  24. Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Sensibility

    Time frame: Baseline

    Sensibility %

  25. Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Specificity

    Time frame: Baseline

    Specificity %

  26. Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive predictive values

    Time frame: Baseline

    Positive predictive values %

  27. Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative predictive values

    Time frame: Baseline

    Negative predictive values %

  28. Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive likelihood ratio

    Time frame: Baseline

    Positive likelihood ratio %

  29. Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative likelihood ratio

    Time frame: Baseline

    Negative likelihood ratio %

  30. Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Sensibility

    Time frame: Baseline

    Sensibility %

  31. Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Specificity

    Time frame: Baseline

    Specificity %

  32. Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive predictive values

    Time frame: Baseline

    Positive predictive values %

  33. Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative predictive values

    Time frame: Baseline

    Negative predictive values %

  34. Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive likelihood ratio

    Time frame: Baseline

    Positive likelihood ratio %

  35. Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative likelihood ratio

    Time frame: Baseline

    Negative likelihood ratio %

  36. Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Sensibility

    Time frame: Baseline

    Sensibility %

  37. Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Specificity

    Time frame: Baseline

    Specificity %

  38. Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive predictive values

    Time frame: Baseline

    Positive predictive values %

  39. Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative predictive values

    Time frame: Baseline

    Negative predictive values %

  40. Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive likelihood ratio

    Time frame: Baseline

    Positive likelihood ratio %

  41. Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative likelihood ratio

    Time frame: Baseline

    Negative likelihood ratio %

  42. Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Sensibility

    Time frame: Baseline

    Sensibility %

  43. Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Specificity

    Time frame: Baseline

    Specificity %

  44. Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive predictive values

    Time frame: Baseline

    Positive predictive values %

  45. Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative predictive values

    Time frame: Baseline

    Negative predictive values %

  46. Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive likelihood ratio

    Time frame: Baseline

    Positive likelihood ratio %

  47. Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative likelihood ratio

    Time frame: Baseline

    Negative likelihood ratio %

  48. Visually analyze the shape of the Diaphragmatic curves (DC) of patients seen for ARD in the emergency department and whose cause is mixed (association of at least two causes).

    Time frame: Baseline

    Descriptive analysis of curve shapes

  49. Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. Positive predictive values

    Time frame: Baseline

    Positive predictive values %

Study contacts

Contact information is provided by the study sponsor or research team.

DINO TIKVESA, MD

CONTACT

[email protected]

0467337974 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Evaluation of the Relevance of Diaphragmatic Stroke Ultrasound for the Etiological Diagnosis of Acute Respiratory Distress in an Emergency Department: a Prospective Multicenter Study.

Acronym: EchoDiaph

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 21, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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