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

October 11, 2020 updated by: Matthieu Daniel, European Georges Pompidou Hospital

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

390

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nîmes, France, 30000
        • Recruiting
        • Nîmes University Hospital
        • Contact:
          • Xavier Bobbia, MD
      • Paris, France, 75015
        • Recruiting
        • Georges Pompidou European Hospital
        • Principal Investigator:
          • Matthieu Daniel, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Florent Femy, MD
      • Saint-Denis, France, 97405
        • Recruiting
        • Bellepierre Hospital
        • Contact:
          • Gwenola Allain-Jeannic, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Every patient over 18, with known or suspected COPD, admitted to the ER for Respiratory Failure.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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)
During the 24 first hours after admission to the ED

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: During the first 24 hours after admission to ED
the E-T index for the use of invasive ventilation
During the first 24 hours after admission to ED
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
Time Frame: 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
Through study completion, an average of 2 years
Assessment of staff learning curves senior and junior medical staff participating in initial training.
Time Frame: Through study completion, an average of 2 years
Evaluation of learning curves
Through study completion, an average of 2 years
Assess the inter-observer feasibility and reproducibility of the measurement of ED and IET measured by ultrasound in time-movement mode (TM)
Time Frame: Through study completion, an average of 2 years
Inter-operator feasibility and reproducibility of ED and IET
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Georges Pompidou Hospital

Investigators

  • Principal Investigator: Matthieu DANIEL, MD, European Georges Pompidou Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2019

Primary Completion (Anticipated)

January 23, 2022

Study Completion (Anticipated)

July 23, 2022

Study Registration Dates

First Submitted

October 3, 2020

First Submitted That Met QC Criteria

October 11, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 11, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EuroeanGPH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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