PneumoniaEchoDiaphNCT06650137
Evaluation of the Relevance of Diaphragmatic Stroke Ultrasound for the Etiological Diagnosis of Acute Respiratory Distress in an Emergency Department.
A study testing diaphragmatic ultrasound in people with Pneumonia and Diaphragm; Movement, run by University Hospital, Montpellier at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Diaphragm; Movement, Diaphragmatic Ultrasound
- What is being tested?
- diaphragmatic ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Nov 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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,
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
University Hospital of Montpellier
Montpellier, Hérault, 34295
Dino TIKVESA, MD, 0467337974 ext. +33, d-tikvesa@chu-montpellier.fr
- Not yet recruiting
University Hospital of Nîmes
Nîmes, Gard, 30900
Fabien COISY, MD, 0612194369 ext. +33, fabien.coisy@gmail.com
About this study
Official 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.
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Pneumonia, Diaphragm; Movement, Diaphragmatic Ultrasound, Emergency Medical Services, Acute Respiratory Distress Syndrome (ARDS)
- Being tested
- diaphragmatic ultrasound
- Keywords
- Diaphragmatic ultrasound,, ultrasonography, Pneumonia, Diaphragm, Acute respiratory failure, Emergency, Diaphragmatic excursion
- Medical subject headings
- Pneumonia, Respiratory Distress Syndrome, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diaphragmatic ultrasoundDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Adult emergency patients with acute respiratory distress | Experimental | Subjects aged ≥ 18 years presenting to the emergency department with ARD defined by respiratory rate (RR) > 25 and/or signs of struggle.
Every potentially eligible patient will have a right diaphragmatic ultrasound performed by a doctor trained in the technique. Receives: Diagnostic Test: diaphragmatic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
Measured: Baseline
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)
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).
Measured: Baseline
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)
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).
Measured: Baseline
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)
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).
Measured: Baseline
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)
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
Measured: Baseline
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)
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
Measured: Baseline
Secondary outcomes (49)
Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (Sensibility)
Sensibility %
Measured: Baseline
Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (Specificity)
Specificity %
Measured: Baseline
Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (Positive predictive values (%))
Positive predictive values (%)
Measured: Baseline
Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (Negative predictive values (%))
Negative predictive values (%)
Measured: Baseline
Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (Positive likelihood ratio (%))
Positive likelihood ratio (%)
Measured: Baseline
Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (Negative likelihood ratio (%))
Negative likelihood ratio (%)
Measured: Baseline
Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department (Sensibility )
Sensibility %
Measured: Baseline
Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency departmentSpecificity
Specificity %
Measured: Baseline
Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. Negative predictive values
Negative predictive values %
Measured: Baseline
Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. Positive likelihood ratio
Positive likelihood ratio %
Measured: Baseline
Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. Negative likelihood ratio
Negative likelihood ratio %
Measured: Baseline
Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Sensibility
Sensibility %
Measured: Baseline
Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Specificity
Specificity %
Measured: Baseline
Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive predictive values
Positive predictive values %
Measured: Baseline
Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative predictive values
Negative predictive values %
Measured: Baseline
Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive likelihood ratio
Positive likelihood ratio %
Measured: Baseline
Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative likelihood ratio
Negative likelihood ratio %
Measured: Baseline
Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Sensibility
Sensibility %
Measured: Baseline
Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Specificity
Specificity %
Measured: Baseline
Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive predictive values
Positive predictive values %
Measured: Baseline
Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative predictive values
Negative predictive values %
Measured: Baseline
Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive likelihood ratio
Positive likelihood ratio %
Measured: Baseline
Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative likelihood ratio
Negative likelihood ratio %
Measured: Baseline
Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Sensibility
Sensibility %
Measured: Baseline
Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Specificity
Specificity %
Measured: Baseline
Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive predictive values
Positive predictive values %
Measured: Baseline
Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative predictive values
Negative predictive values %
Measured: Baseline
Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive likelihood ratio
Positive likelihood ratio %
Measured: Baseline
Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative likelihood ratio
Negative likelihood ratio %
Measured: Baseline
Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Sensibility
Sensibility %
Measured: Baseline
Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Specificity
Specificity %
Measured: Baseline
Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive predictive values
Positive predictive values %
Measured: Baseline
Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative predictive values
Negative predictive values %
Measured: Baseline
Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive likelihood ratio
Positive likelihood ratio %
Measured: Baseline
Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative likelihood ratio
Negative likelihood ratio %
Measured: Baseline
Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Sensibility
Sensibility %
Measured: Baseline
Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Specificity
Specificity %
Measured: Baseline
Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive predictive values
Positive predictive values %
Measured: Baseline
Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative predictive values
Negative predictive values %
Measured: Baseline
Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive likelihood ratio
Positive likelihood ratio %
Measured: Baseline
Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative likelihood ratio
Negative likelihood ratio %
Measured: Baseline
Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Sensibility
Sensibility %
Measured: Baseline
Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Specificity
Specificity %
Measured: Baseline
Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive predictive values
Positive predictive values %
Measured: Baseline
Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative predictive values
Negative predictive values %
Measured: Baseline
Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive likelihood ratio
Positive likelihood ratio %
Measured: Baseline
Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative likelihood ratio
Negative likelihood ratio %
Measured: Baseline
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).
Descriptive analysis of curve shapes
Measured: Baseline
Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. Positive predictive values
Positive predictive values %
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start27 Nov 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective interventional multicenter diagnostic study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DINO TIKVESA, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650137
- Sponsor's protocol ID
- RECHMPL23_0425
- Acronym
- EchoDiaph
- Status last verified
- Dec 2024
- First submitted
- 4 Oct 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jouneau S, Dres M, Guerder A, Bele N, Bellocq A, Bernady A, Berne G, Bourdin A, Brinchault G, Burgel PR, Carlier N, Chabot F, Chavaillon JM, Cittee J, Claessens YE, Delclaux B, Deslee G, Ferre A, Gacouin A, Girault C, Ghasarossian C, Gouilly P, Gut-Gobert C, Gonzalez-Bermejo J, Jebrak G, Le Guillou F, Leveiller G, Lorenzo A, Mal H, Molinari N, Morel H, Morel V, Noel F, Pegliasco H, Perotin JM, Piquet J, Pontier S, Rabbat A, Revest M, Reychler G, Stelianides S, Surpas P, Tattevin P, Roche N. Management of acute exacerbations of chronic obstructive pulmonary disease (COPD). Guidelines from the Societe de pneumologie de langue francaise (summary). Rev Mal Respir. 2017 Apr;34(4):282-322. doi: 10.1016/j.rmr.2017.03.034. Epub 2017 May 25.
PubMed 28552256McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. No abstract available.
PubMed 22611136Abdallah S, Pihan F, Vandroux D. Échographie diaphragmatique : applications au-delà du sevrage de la ventilation. Le Praticien en Anesthésie Réanimation. 1 sept 2023;27(4):205-11.
Jung B, Guillon A, pour la Commission de la recherche translationnelle de la SRLF. Échographie du diaphragme en réanimation. Schnell D, Charles PE, éditeurs. Méd Intensive Réa. janv 2019;28(1):60-3
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06650137
- Acronym / sponsor ID
- EchoDiaph / RECHMPL23_0425
- Conditions
- Pneumonia, Diaphragm; Movement, Diaphragmatic Ultrasound, Emergency Medical Services, Acute Respiratory Distress Syndrome (ARDS)
- Keywords
- Diaphragmatic ultrasound,, ultrasonography, Pneumonia, Diaphragm, Acute respiratory failure, Emergency, Diaphragmatic excursion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective interventional multicenter diagnostic study
| Arm | Type | Receives |
|---|---|---|
| Adult emergency patients with acute respiratory distress | Experimental | Diagnostic Test: diaphragmatic ultrasoundSubjects aged ≥ 18 years presenting to the emergency department with ARD defined by respiratory rate (RR) > 25 and/or signs of struggle. Every potentially eligible patient will have a right diaphragmatic ultrasound performed by a doctor trained in the technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diaphragmatic ultrasoundThe 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. | Diagnostic test | Adult emergency patients with acute respiratory distress |
Primary outcome
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)
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).
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).
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).
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
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
49 secondary outcomes
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
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
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
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
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
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
Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department (Sensibility )
Time frame: Baseline
Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency departmentSpecificity
Time frame: Baseline
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Sensibility
Time frame: Baseline
Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Specificity
Time frame: Baseline
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
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
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
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
Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Sensibility
Time frame: Baseline
Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Specificity
Time frame: Baseline
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 28552256Jouneau S, Dres M, Guerder A, Bele N, Bellocq A, Bernady A, Berne G, Bourdin A, Brinchault G, Burgel PR, Carlier N, Chabot F, Chavaillon JM, Cittee J, Claessens YE, Delclaux B, Deslee G, Ferre A, Gacouin A, Girault C, Ghasarossian C, Gouilly P, Gut-Gobert C, Gonzalez-Bermejo J, Jebrak G, Le Guillou F, Leveiller G, Lorenzo A, Mal H, Molinari N, Morel H, Morel V, Noel F, Pegliasco H, Perotin JM, Piquet J, Pontier S, Rabbat A, Revest M, Reychler G, Stelianides S, Surpas P, Tattevin P, Roche N. Management of acute exacerbations of chronic obstructive pulmonary disease (COPD). Guidelines from the Societe de pneumologie de langue francaise (summary). Rev Mal Respir. 2017 Apr;34(4):282-322. doi: 10.1016/j.rmr.2017.03.034. Epub 2017 May 25.
- Background: PubMed 22611136McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. No abstract available.
- BackgroundAbdallah S, Pihan F, Vandroux D. Échographie diaphragmatique : applications au-delà du sevrage de la ventilation. Le Praticien en Anesthésie Réanimation. 1 sept 2023;27(4):205-11.
- BackgroundJung B, Guillon A, pour la Commission de la recherche translationnelle de la SRLF. Échographie du diaphragme en réanimation. Schnell D, Charles PE, éditeurs. Méd Intensive Réa. janv 2019;28(1):60-3
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
DINO TIKVESA, MD principal investigator
University Hospital, Montpellier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diaphragmatic ultrasound in people with Pneumonia and Diaphragm; Movement, run by University Hospital, Montpellier at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DINO TIKVESA, MD (0467337974 ext. +33, d-tikvesa@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06650137, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.