Predictability of Echographic Excursion of the Diaphragm for Intubation in COPD- Patients With Acute Respiratory Failure in ED
- Conditions
- COPD ExacerbationRespiratory Failure
- Registration Number
- NCT04591509
- Lead Sponsor
- European Georges Pompidou Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 390
-
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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) During the 24 first hours after admission to the ED predictive value of the presence of a diaphragmatic dysfunction on the use of invasive mechanical ventilation (IV)
- Secondary Outcome Measures
Name Time Method 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 Through study completion, an average of 2 years Duration of stay, ventilation (invasive and non-invasive), respiratory complications and the values of ED and E-T index
Assessment of staff learning curves senior and junior medical staff participating in initial training. Through study completion, an average of 2 years Evaluation of learning curves
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 During the first 24 hours after admission to ED the E-T index for the use of invasive ventilation
Assess the inter-observer feasibility and reproducibility of the measurement of ED and IET measured by ultrasound in time-movement mode (TM) Through study completion, an average of 2 years Inter-operator feasibility and reproducibility of ED and IET
Trial Locations
- Locations (3)
Nîmes University Hospital
🇫🇷Nîmes, France
Georges Pompidou European Hospital
🇫🇷Paris, France
Bellepierre Hospital
🇫🇷Saint-Denis, France