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

NCT ID: NCT04591509

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 390 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-23
• Study Completion Date: 2022-07-23

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.

Conditions

COPD Exacerbation; Respiratory Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Georges Pompidou Hospital

OTHER

Sponsor Role: lead

Responsible Party

Matthieu Daniel

Head of Clinic - Intensive Care Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthieu DANIEL, MD

Role: PRINCIPAL_INVESTIGATOR

European Georges Pompidou Hospital

Locations

Nîmes University Hospital

Nîmes, , France

Site Status: RECRUITING

Georges Pompidou European Hospital

Paris, , France

Site Status: RECRUITING

Bellepierre Hospital

Saint-Denis, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Matthieu DANIEL, MD

Role: CONTACT

matthieu.daniel2309@gmail.com

+33637617673

Facility Contacts

Xavier Bobbia, MD

Role: primary

Matthieu Daniel, MD

Role: primary

matthieu.daniel2309@gmail.com

+33(0)156095813

Florent Femy, MD

Role: backup

florent.femy@aphp.fr

‭+33 6 42 40 05 33‬

Gwenola Allain-Jeannic, MD

Role: primary

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Other Identifiers

EuroeanGPH

Identifier Type: -

Identifier Source: org_study_id