COPD ExacerbationPREEDICT-EDNCT04591509
Predictability of Echographic Excursion of the Diaphragm for Intubation in COPD- Patients With Acute Respiratory Failure in ED
An observational study of COPD Exacerbation and Respiratory Failure, run by European Georges Pompidou Hospital at 3 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation, Respiratory Failure
- How many people
- 390 participants
- Where
- 3 sitesFrance
- Study dates
- 23 Jul 2019to 23 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Every patient over 18, with known or suspected COPD, admitted to the ER for Respiratory Failure.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Nîmes University Hospital
Nîmes, 30000
Xavier Bobbia, MD
- Recruiting
Georges Pompidou European Hospital
Paris, 75015
Matthieu Daniel, MD, +33(0)156095813, matthieu.daniel2309@gmail.com
Florent Femy, MD, +33 6 42 40 05 33, florent.femy@aphp.fr
- Recruiting
Bellepierre Hospital
Saint-Denis, 97405
Gwenola Allain-Jeannic, MD
About this study
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
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.
Read the 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
- Medical subject headings
- Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During the 24 first hours after admission to the ED
Secondary outcomes (4)
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
Measured: 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
Duration of stay, ventilation (invasive and non-invasive), respiratory complications and the values of ED and E-T index
Measured: Through study completion, an average of 2 years
Assessment of staff learning curves senior and junior medical staff participating in initial training.
Evaluation of learning curves
Measured: 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)
Inter-operator feasibility and reproducibility of ED and IET
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start23 Jul 2019
- Primary completion23 Jan 2022 (estimated)
- Study completion23 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Georges Pompidou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthieu Daniel, European Georges Pompidou Hospital
- Investigators
- Matthieu DANIEL, MD, Principal investigator, European Georges Pompidou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591509
- Sponsor's protocol ID
- EuroeanGPH
- Acronym
- PREEDICT-ED
- Status last verified
- Oct 2020
- First submitted
- 3 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Osadnik CR, Tee VS, Carson-Chahhoud KV, Picot J, Wedzicha JA, Smith BJ. Non-invasive ventilation for the management of acute hypercapnic respiratory failure due to exacerbation of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2017 Jul 13;7(7):CD004104. doi: 10.1002/14651858.CD004104.pub4.
PubMed 28702957Guttikonda SNR, Vadapalli K. Approach to undifferentiated dyspnea in emergency department: aids in rapid clinical decision-making. Int J Emerg Med. 2018 Apr 4;11(1):21. doi: 10.1186/s12245-018-0181-z.
PubMed 29619581Palkar 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.
PubMed 29353023Bobbia X, Clement 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.
PubMed 27251231Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18.
PubMed 19017880Marchioni A, Castaniere I, Tonelli R, Fantini R, Fontana M, Tabbi 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.
PubMed 29703214Zanobetti M, Scorpiniti M, Gigli C, Nazerian P, Vanni S, Innocenti F, Stefanone VT, Savinelli C, Coppa A, Bigiarini S, Caldi F, Tassinari I, Conti A, Grifoni S, Pini R. Point-of-Care Ultrasonography for Evaluation of Acute Dyspnea in the ED. Chest. 2017 Jun;151(6):1295-1301. doi: 10.1016/j.chest.2017.02.003. Epub 2017 Feb 16.
PubMed 28212836Malas O, Caglayan B, Fidan A, Ocal Z, Ozdogan S, Torun E. Cardiac or pulmonary dyspnea in patients admitted to the emergency department. Respir Med. 2003 Dec;97(12):1277-81. doi: 10.1016/j.rmed.2003.07.002.
PubMed 14682407Mueller C, Scholer A, Laule-Kilian K, Martina B, Schindler C, Buser P, Pfisterer M, Perruchoud AP. Use of B-type natriuretic peptide in the evaluation and management of acute dyspnea. N Engl J Med. 2004 Feb 12;350(7):647-54. doi: 10.1056/NEJMoa031681.
PubMed 14960741Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9.
PubMed 22878278Rodriguez-Roisin R. Toward a consensus definition for COPD exacerbations. Chest. 2000 May;117(5 Suppl 2):398S-401S. doi: 10.1378/chest.117.5_suppl_2.398s.
PubMed 10843984Brochard L, Mancebo J, Wysocki M, Lofaso F, Conti G, Rauss A, Simonneau G, Benito S, Gasparetto A, Lemaire F, et al. Noninvasive ventilation for acute exacerbations of chronic obstructive pulmonary disease. N Engl J Med. 1995 Sep 28;333(13):817-22. doi: 10.1056/NEJM199509283331301.
PubMed 7651472Bobbia 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.
PubMed 24456614Antenora 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.
PubMed 27743430De Troyer A, Wilson TA. Effect of acute inflation on the mechanics of the inspiratory muscles. J Appl Physiol (1985). 2009 Jul;107(1):315-23. doi: 10.1152/japplphysiol.91472.2008. Epub 2009 Mar 5.
PubMed 19265064
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04591509
- Acronym / sponsor ID
- PREEDICT-ED / EuroeanGPH
- Conditions
- COPD Exacerbation, Respiratory Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- European Georges Pompidou HospitalUniversity, hospital or other
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 23 Jan 2022 (estimated)
- Study completion
- 23 Jul 2022 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patient over 18, with known or suspected COPD, admitted to the ER for Respiratory Failure.
Key inclusion criteria (5 listed)
- Spontaneous ventilation at arrival to the ER
- With Respiratory Failure defined by at least of the following criterias :
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
4 secondary outcomes
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
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
Assessment of staff learning curves senior and junior medical staff participating in initial training.
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Background: PubMed 28702957Osadnik CR, Tee VS, Carson-Chahhoud KV, Picot J, Wedzicha JA, Smith BJ. Non-invasive ventilation for the management of acute hypercapnic respiratory failure due to exacerbation of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2017 Jul 13;7(7):CD004104. doi: 10.1002/14651858.CD004104.pub4.
- Background: PubMed 29619581Guttikonda SNR, Vadapalli K. Approach to undifferentiated dyspnea in emergency department: aids in rapid clinical decision-making. Int J Emerg Med. 2018 Apr 4;11(1):21. doi: 10.1186/s12245-018-0181-z.
- Background: PubMed 29353023Palkar 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.
- Background: PubMed 27251231Bobbia X, Clement 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.
- Background: PubMed 19017880Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18.
- Background: PubMed 29703214Marchioni A, Castaniere I, Tonelli R, Fantini R, Fontana M, Tabbi 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.
- Background: PubMed 28212836Zanobetti M, Scorpiniti M, Gigli C, Nazerian P, Vanni S, Innocenti F, Stefanone VT, Savinelli C, Coppa A, Bigiarini S, Caldi F, Tassinari I, Conti A, Grifoni S, Pini R. Point-of-Care Ultrasonography for Evaluation of Acute Dyspnea in the ED. Chest. 2017 Jun;151(6):1295-1301. doi: 10.1016/j.chest.2017.02.003. Epub 2017 Feb 16.
- Background: PubMed 14682407Malas O, Caglayan B, Fidan A, Ocal Z, Ozdogan S, Torun E. Cardiac or pulmonary dyspnea in patients admitted to the emergency department. Respir Med. 2003 Dec;97(12):1277-81. doi: 10.1016/j.rmed.2003.07.002.
- Background: PubMed 14960741Mueller C, Scholer A, Laule-Kilian K, Martina B, Schindler C, Buser P, Pfisterer M, Perruchoud AP. Use of B-type natriuretic peptide in the evaluation and management of acute dyspnea. N Engl J Med. 2004 Feb 12;350(7):647-54. doi: 10.1056/NEJMoa031681.
- Background: PubMed 22878278Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9.
- Background: PubMed 10843984Rodriguez-Roisin R. Toward a consensus definition for COPD exacerbations. Chest. 2000 May;117(5 Suppl 2):398S-401S. doi: 10.1378/chest.117.5_suppl_2.398s.
- Background: PubMed 7651472Brochard L, Mancebo J, Wysocki M, Lofaso F, Conti G, Rauss A, Simonneau G, Benito S, Gasparetto A, Lemaire F, et al. Noninvasive ventilation for acute exacerbations of chronic obstructive pulmonary disease. N Engl J Med. 1995 Sep 28;333(13):817-22. doi: 10.1056/NEJM199509283331301.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthieu DANIEL, MD principal investigator
European Georges Pompidou Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation and Respiratory Failure, run by European Georges Pompidou Hospital at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthieu DANIEL, MD (+33637617673, matthieu.daniel2309@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04591509, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.