Skip to content

Predictability of Echographic Excursion of the Diaphragm for Intubation in COPD- Patients With Acute Respiratory Failure in ED

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04591509
Acronym
PREEDICT-ED
Enrollment
390
Registered
2020-10-19
Start date
2019-07-23
Completion date
2022-07-23
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Exacerbation, 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.

Interventions

None listed

Sponsors

European Georges Pompidou Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 EDpredictive value of the presence of a diaphragmatic dysfunction on the use of invasive mechanical ventilation (IV)

Secondary

MeasureTime frameDescription
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 invasiveDuring the first 24 hours after admission to EDthe E-T index for the use of invasive ventilation
Find a correlation between length of stay, length of ventilation, respiratory complications and the values of ED and E-T index measured at patient admissionThrough study completion, an average of 2 yearsDuration 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 yearsEvaluation of learning curves
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 yearsInter-operator feasibility and reproducibility of ED and IET

Countries

France

Contacts

Primary ContactMatthieu DANIEL, MD
matthieu.daniel2309@gmail.com+33637617673

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026