September 5, 2019
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September 16, 2019
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September 16, 2019
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September 15, 2019
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April 2020 (Final data collection date for primary outcome measure)
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Change in dyspnea severity on a verbal dyspnea scale (VDS) from 0-10 [ Time Frame: Assessed within 1 hour from arrival, again after two, four hours and five hours ] Self reported severity of dyspnea. 0 = no dyspnea. 10 = worst dyspnea ever.
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Same as current
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No Changes Posted
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- Lenght of stay [ Time Frame: Assessed after 30 days from inclusion of the last patient. ]
Number of days the patients is admitted.
- Number of readmission(s) [ Time Frame: Assessed up to 12 months from inclusion of the last patient. ]
Number of times the patients is readmitted after discharge.
- In-hospital all-cause mortality [ Time Frame: Assessed after 30 days from inclusion of the last patient. ]
Number of patients who dies under the admission
- All-cause mortality after discharge [ Time Frame: Assessed up to 12 months from inclusion of the last patient. ]
Number of patients who dies after discharge.
- IVC-CI (inferior vena cava collapsibility index) correlated to vital signs and VDS [ Time Frame: Assessed within 1 hour from arrival, again after two, four hours and five hours ]
- B-line count correlated to vital signs and VDS [ Time Frame: Assessed within 1 hour from arrival, again after two, four hours and five hours ]
- The changes in IVC-CI between the ultrasound examinations [ Time Frame: Assessed within 1 hour from arrival, again after two, four hours and five hours ]
- The changes in B-line count between the ultrasound examinations [ Time Frame: Assessed within 1 hour from arrival, again after two, four hours and five hours ]
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Same as current
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Not Provided
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Not Provided
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Monitoring Patients With Shortness of Breath With Repeated Ultrasound Examinations
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Monitoring Patients With Acute Dyspnea With Serial Focused Ultrasound of the Heart and the Lungs
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Purpose of the study: The purpose of the trial is to investigate whether repeated ultrasound scans of the heart and lungs of patients with shortness of breath may help to optimize their treatment. This patient group is characterized by an extended hospitalization and a high mortality rate. Therefore, it is essential to be able to target the treatment in order to shorten length of stay, prevent readmissions, and improve survival in these patients. Ultrasound scanning used in this way is novel.
The study method: Initially, all patients will receive standard evaluation and ultrasound of the heart and the lungs. Then the patients are randomly assigned into two groups. In one group, patients receive standard assessment and treatment. In the second group, the patients, in addition to standard examination and treatment, receive ultrasound scans of their heart and lungs after two hours and again fire hours after the first scan.
After discharge, the subjects are followed for one year to evaluate what examinations and treatment they received during hospitalization, whether they have been readmitted or died.
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Design: Multicenter, randomized, controlled, open-label, and pragmatic trial.
Settings: Several different emergency departments (EDs) in Denmark.
Study flow: After arrival, the patients are screened according to eligibility criteria. If patients meet the inclusion criteria and informed consent is obtained, the patients are randomly assigned to one of two groups. In both groups, the patients received standard evaluation, e.g., blood samples, physical examination, arterial blood gas, and in addition ultrasound examination of the heart and the lungs. In the intervention group, the patients are further examined with serial ultrasound scans of the heart and the lungs after two and four hours after the initial evaluation.
In the course of admittance, the patients will have there baseline characteristics recorded together with the ultrasound findings, symptoms, and vitals. Symptoms will be recorded at a verbal dyspnea symptom scale (VDS) from 0-10.
All data will be registered at the same time points to make comparisons: At 1, 2, 4 and after 5 hours.
Sample size: This is calculated from the primary outcome and with an assumption of a power of 80%, type 1-error of 5%, and 10% dropouts. The calculations are based on previous studies using the VDS on patients with acute dyspnea. The sample size is 103 patients in each group.
Statistical analysis: Baseline characteristics will be summarized and divided into the intervention and control group. Continuous variables will be summarized as means and standard deviation (SD) or medians and interquartile range (IQR) depending on the distribution of the variable. For categorical variables, frequencies and percentages will be reported.
The primary outcome - change in dyspnea on VDS - will be compared between the two groups to detect any difference. Pairwise comparisons of VDS will be made at the same time points in both groups.
The secondary outcomes: Length of stay, death, and the number of readmissions will be compared between the two groups to detect a difference. Time-to-event (dead or readmission) will be visualized with Kaplan Meier curves.
In the case of lost to follow-up or other reasons for missing data both intention-to-treat and per-protocol analysis will be used.
The secondary outcomes in the interventions group: The dynamic changes in inferior vena cava collapsibility index (IVC-CI) and the sum of B-lines will be expressed as means and SD or median and IQR depending on the distribution of the data and compared between the different time points. Furthermore, IVC-CI and the sum of B-lines will be compared to vitals and VDS-score to detect a correlation.
The inter- and intraobserver variability regarding the focused ultrasound will be accessed.
Data management: The registered data on each patient will be recorded and securely stored in an encrypted, logged, and password-protected database called REDCap. All adjustments in the database are logged. The patients are anonymized.
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Interventional
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Not Applicable
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Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment
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Dyspnea
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- Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5.
- Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, González-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P. 2016 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure. Rev Esp Cardiol (Engl Ed). 2016 Dec;69(12):1167. doi: 10.1016/j.rec.2016.11.005. English, Spanish. Erratum in: Rev Esp Cardiol (Engl Ed). 2017 Apr;70(4):309-310.
- Gargani L, Volpicelli G. How I do it: lung ultrasound. Cardiovasc Ultrasound. 2014 Jul 4;12:25. doi: 10.1186/1476-7120-12-25.
- Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6. Review.
- Kelly N, Esteve R, Papadimos TJ, Sharpe RP, Keeney SA, DeQuevedo R, Portner M, Bahner DP, Stawicki SP. Clinician-performed ultrasound in hemodynamic and cardiac assessment: a synopsis of current indications and limitations. Eur J Trauma Emerg Surg. 2015 Oct;41(5):469-80. doi: 10.1007/s00068-014-0492-6. Epub 2015 Jan 8. Review.
- Gaskamp M, Blubaugh M, McCarthy LH, Scheid DC. Can Bedside Ultrasound Inferior Vena Cava Measurements Accurately Diagnose Congestive Heart Failure in the Emergency Department? A Clin-IQ. J Patient Cent Res Rev. 2016 Fall-Winter;3(4):230-234. Epub 2016 Nov 11.
- Blehar DJ, Dickman E, Gaspari R. Identification of congestive heart failure via respiratory variation of inferior vena cava diameter. Am J Emerg Med. 2009 Jan;27(1):71-75. doi: 10.1016/j.ajem.2008.01.002.
- Volpicelli G, Caramello V, Cardinale L, Mussa A, Bar F, Frascisco MF. Bedside ultrasound of the lung for the monitoring of acute decompensated heart failure. Am J Emerg Med. 2008 Jun;26(5):585-91. doi: 10.1016/j.ajem.2007.09.014.
- Via G, Storti E, Gulati G, Neri L, Mojoli F, Braschi A. Lung ultrasound in the ICU: from diagnostic instrument to respiratory monitoring tool. Minerva Anestesiol. 2012 Nov;78(11):1282-96. Epub 2012 Aug 3. Review.
- Martindale JL. Resolution of sonographic B-lines as a measure of pulmonary decongestion in acute heart failure. Am J Emerg Med. 2016 Jun;34(6):1129-32. doi: 10.1016/j.ajem.2016.03.043. Epub 2016 Mar 19. Review.
- Ramasubbu K, Deswal A, Chan W, Aguilar D, Bozkurt B. Echocardiographic changes during treatment of acute decompensated heart failure: insights from the ESCAPE trial. J Card Fail. 2012 Oct;18(10):792-8. doi: 10.1016/j.cardfail.2012.08.358.
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- Ferrada P, Evans D, Wolfe L, Anand RJ, Vanguri P, Mayglothling J, Whelan J, Malhotra A, Goldberg S, Duane T, Aboutanos M, Ivatury RR. Findings of a randomized controlled trial using limited transthoracic echocardiogram (LTTE) as a hemodynamic monitoring tool in the trauma bay. J Trauma Acute Care Surg. 2014 Jan;76(1):31-7; discussion 37-8. doi: 10.1097/TA.0b013e3182a74ad9.
- Yavaşi Ö, Ünlüer EE, Kayayurt K, Ekinci S, Sağlam C, Sürüm N, Köseoğlu MH, Yeşil M. Monitoring the response to treatment of acute heart failure patients by ultrasonographic inferior vena cava collapsibility index. Am J Emerg Med. 2014 May;32(5):403-7. doi: 10.1016/j.ajem.2013.12.046. Epub 2014 Jan 3.
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- Via G, Hussain A, Wells M, Reardon R, ElBarbary M, Noble VE, Tsung JW, Neskovic AN, Price S, Oren-Grinberg A, Liteplo A, Cordioli R, Naqvi N, Rola P, Poelaert J, Guliĉ TG, Sloth E, Labovitz A, Kimura B, Breitkreutz R, Masani N, Bowra J, Talmor D, Guarracino F, Goudie A, Xiaoting W, Chawla R, Galderisi M, Blaivas M, Petrovic T, Storti E, Neri L, Melniker L; International Liaison Committee on Focused Cardiac UltraSound (ILC-FoCUS); International Conference on Focused Cardiac UltraSound (IC-FoCUS). International evidence-based recommendations for focused cardiac ultrasound. J Am Soc Echocardiogr. 2014 Jul;27(7):683.e1-683.e33. doi: 10.1016/j.echo.2014.05.001. Review.
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Not yet recruiting
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206
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Same as current
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May 2021
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April 2020 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
- Participants should be 18 years or older
- Presented at the ED with shortness of breath (asking the patient upon arrival in the triage what their primary complaint is for a referral to an emergency department)
- Written informed consent obtained from the patient
Exclusion Criteria:
- Patients with dyspnea primary admitted because of a trauma
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Sexes Eligible for Study: |
All |
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18 Years and older (Adult, Older Adult)
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No
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Not Provided
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NCT04091334
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REG-056-2019
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No
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Studies a U.S. FDA-regulated Drug Product: |
No |
Studies a U.S. FDA-regulated Device Product: |
No |
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Plan to Share IPD: |
Yes |
Plan Description: |
Raw data (deidentified participant data) may be made available upon request to the corresponding author. |
Supporting Materials: |
Study Protocol |
Supporting Materials: |
Statistical Analysis Plan (SAP) |
Supporting Materials: |
Informed Consent Form (ICF) |
Supporting Materials: |
Clinical Study Report (CSR) |
Time Frame: |
Data will be available within 6 months from the completion of the trial. |
Access Criteria: |
Data can be made available if data sharing is in accordance with applicable legislation on the processing of personal data (The General Data Protection Regulation (GDPR)) and Danish Act on Data Protection. Data will be provided through a secured mailing address. Data can only be reused after acceptance from the project manager. |
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Slagelse Hospital
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Slagelse Hospital
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- Odense University Hospital
- Holbaek Sygehus
- Zealand University Hospital
- Horsens Hospital
- Herning Hospital
- Hvidovre University Hospital
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Principal Investigator: |
Michael D. Arvig, MD |
Dept. of Emergency Medicine, Slagelse Hospital |
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Slagelse Hospital
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September 2019
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