Clinical trial NCT04591509: Predictability of Echographic Excursion of the Diaphragm for Intubation in COPD- Patients With Acute Respiratory Failure in ED
Official title: Predictive Value of Diaphragmatic Excursion by Echographic Assessment at the Bedside on Need for Endotracheal Intubation in COPD Patients With Acute Dyspnea in Emergency Medicine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD Exacerbation
Respiratory Failure
Lead sponsor: European Georges Pompidou Hospital
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Every patient over 18, with known or suspected COPD, admitted to the ER for Respiratory Failure.

Brief summary: The investigators seek to evaluate if the ultra-sound measure of the diaphragm expansion is predictive of admission into an ICU and/or intubation for patients with COPD.

Every patient coming to the ER with shortness of breath and a known or suspected COPD, will undergo standard of care associated with a diaphragm ultrasound.

The investigators will then gather, through the internal databases of the recruiting hospitals, information about admission into ICU and/or intubation.

The investigators think that this technique will help improve early detection of COPD patient requiring mechanical ventilation, using ultrasound, a non invasive technique.

Detailed description: Inclusion of every lawful age patient presenting to the ER with inclusion criterias

The patient must not have exclusion criteria and must have received the information and consent sheets to be signed jointly

Then, the investigators perform an online randomization for the first and second operator and the side (left/right) from which they start the ultrasound assessment.

The investigators then assess diaphragmatic excursion measurements in spontaneously ventilated patient at 45 ° proclive position for each hemi-diaphragm, with the 2 operators blinded to each other, for 3 consecutive respiratory cycles and save the images.

The date of inclusion is then reported in the register.

Eligibility criteria: Inclusion Criteria:

* Spontaneous ventilation at arrival to the ER
* With Respiratory Failure defined by at least of the following criterias :

  * Respiratory frequency \> 25 and/or clinical signs of respiratory failure
  * Hypoxia with a WpO2 \< 90%
  * Hypercapnia \> 45mmHg with a respiratory acidosis

Exclusion Criteria:

* Known diaphragmatic dysfunction
* Necessity of immediate intubation leaving no time for ultrasound measurements of diaphragmatic excursion
* Unable to provide informed consent
* Evolutive or degenerative neurological disease that could affect diaphragmatic function
* Intracranial Hypertension
* Haemodynamic instability
* Acute heart failure
* Pregnant or Breastfeeding

Primary outcomes:
measure: Evaluate the predictive value of the presence of diaphragmatic dysfunction diagnosed by ultrasound measurement of the diaphragmatic excursion (ED) on the use of invasive mechanical ventilation (IV)
timeFrame: During the 24 first hours after admission to the ED
Secondary outcomes:
measure: Evaluate the predictive value of the ultrasound measurement of the E-T index for the use of invasive ventilation E-T index (IET) on the use of mechanical ventilation invasive
timeFrame: During the first 24 hours after admission to ED
measure: Find a correlation between length of stay, length of ventilation, respiratory complications and the values of ED and E-T index measured at patient admission
timeFrame: Through study completion, an average of 2 years
measure: Assessment of staff learning curves senior and junior medical staff participating in initial training.
timeFrame: Through study completion, an average of 2 years
measure: Assess the inter-observer feasibility and reproducibility of the measurement of ED and IET measured by ultrasound in time-movement mode (TM)
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Nîmes University Hospital
city: Paris
country: France
facility: Georges Pompidou European Hospital
city: Saint-Denis
country: France
facility: Bellepierre Hospital
Study officials:
affiliation: European Georges Pompidou Hospital
name: Matthieu DANIEL, MD
role: PRINCIPAL_INVESTIGATOR
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