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

Respiratory Failure Clinical Trial

— PREEDICT-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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04591509
• Other study ID #: EuroeanGPH
• Status: Recruiting
• Start date: July 23, 2019
• Est. completion date: July 23, 2022

Study information

• Verified date: October 2020
• Source: European Georges Pompidou Hospital
• Contact: Matthieu DANIEL, MD
• Phone: +33637617673
• Email: matthieu.daniel2309[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: July 23, 2022
• Est. primary completion date: January 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD Exacerbation
• Respiratory Failure
• Respiratory Insufficiency

Locations

Country	Name	City	State
France	Nîmes University Hospital	Nîmes
France	Georges Pompidou European Hospital	Paris
France	Bellepierre Hospital	Saint-Denis

Sponsors (1)

Lead Sponsor	Collaborator
European Georges Pompidou Hospital

Country where clinical trial is conducted

France, 

References & Publications (25)

Antenora F, Fantini R, Iattoni A, Castaniere I, Sdanganelli A, Livrieri F, Tonelli R, Zona S, Monelli M, Clini EM, Marchioni A. Prevalence and outcomes of diaphragmatic dysfunction assessed by ultrasound technology during acute exacerbation of COPD: A pilot study. Respirology. 2017 Feb;22(2):338-344. doi: 10.1111/resp.12916. Epub 2016 Oct 14. — View Citation

Bobbia X, Clément A, Claret PG, Bastide S, Alonso S, Wagner P, Tison T, Muller L, de La Coussaye JE. Diaphragmatic excursion measurement in emergency patients with acute dyspnea: toward a new diagnostic tool? Am J Emerg Med. 2016 Aug;34(8):1653-7. doi: 10.1016/j.ajem.2016.05.055. Epub 2016 May 24. — View Citation

Bobbia X, Hansel N, Muller L, Claret PG, Moreau A, Genre Grandpierre R, Chenaitia H, Lefrant JY, de La Coussaye JE. Availability and practice of bedside ultrasonography in emergency rooms and prehospital setting: a French survey. Ann Fr Anesth Reanim. 2014 Mar;33(3):e29-33. doi: 10.1016/j.annfar.2013.12.010. Epub 2014 Jan 20. — View Citation

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Doucet M, Debigaré R, Joanisse DR, Côté C, Leblanc P, Grégoire J, Deslauriers J, Vaillancourt R, Maltais F. Adaptation of the diaphragm and the vastus lateralis in mild-to-moderate COPD. Eur Respir J. 2004 Dec;24(6):971-9. — View Citation

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Marchioni A, Castaniere I, Tonelli R, Fantini R, Fontana M, Tabbì L, Viani A, Giaroni F, Ruggieri V, Cerri S, Clini E. Ultrasound-assessed diaphragmatic impairment is a predictor of outcomes in patients with acute exacerbation of chronic obstructive pulmonary disease undergoing noninvasive ventilation. Crit Care. 2018 Apr 27;22(1):109. doi: 10.1186/s13054-018-2033-x. — View Citation

McCool FD, Tzelepis GE. Dysfunction of the diaphragm. N Engl J Med. 2012 Mar 8;366(10):932-42. doi: 10.1056/NEJMra1007236. Review. Erratum in: N Engl J Med. 2012 May 31;366(22):2138. — View Citation

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Palkar A, Narasimhan M, Greenberg H, Singh K, Koenig S, Mayo P, Gottesman E. Diaphragm Excursion-Time Index: A New Parameter Using Ultrasonography to Predict Extubation Outcome. Chest. 2018 May;153(5):1213-1220. doi: 10.1016/j.chest.2018.01.007. Epub 2018 Jan 17. — View Citation

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* Note: There are 25 references in all — Click here to view all references

Outcome

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