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Monitoring Patients With Shortness of Breath With Repeated Ultrasound Examinations (MODUS)

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ClinicalTrials.gov Identifier: NCT04091334
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : March 18, 2020
Sponsor:
Collaborators:
Odense University Hospital
Holbaek Sygehus
Zealand University Hospital
Horsens Hospital
Herning Hospital
Hvidovre University Hospital
Information provided by (Responsible Party):
Slagelse Hospital

Tracking Information
First Submitted Date  ICMJE September 5, 2019
First Posted Date  ICMJE September 16, 2019
Last Update Posted Date March 18, 2020
Actual Study Start Date  ICMJE October 9, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2019)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Monitoring Patients With Shortness of Breath With Repeated Ultrasound Examinations
Official Title  ICMJE Monitoring Patients With Acute Dyspnea With Serial Focused Ultrasound of the Heart and the Lungs
Brief Summary

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.
Detailed Description

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dyspnea
Intervention  ICMJE
  • Device: Focused ultrasound of the lungs (FLUS) and focused cardiac ultrasound (FoCUS)

    FLUS: Scanning 8 zones of the front and lateral of the thorax. Record number of B-lines, consolidations, pneumothorax, pleural effusions.

    FoCUS: Scan the heart in different views and record the ejection fraction, size of the right side of the heart, pericardial effusion, tricuspid annular plane systolic excursion (TAPSE), inferior vena cava (IVC) diameter, and IVC collapsibility Index (IVC-CI).

  • Other: Standard care
    Standard care and evaluation and monitoring
Study Arms  ICMJE
  • Experimental: Serial ultrasound group

    Will received standard care and monitoring and in addition, have focused ultrasound examination of the heart and the lungs done twice.

    The investigator is supposed to titrate the treatment according to the findings on the ultrasound examinations.

    Interventions:
    • Device: Focused ultrasound of the lungs (FLUS) and focused cardiac ultrasound (FoCUS)
    • Other: Standard care
  • Active Comparator: Standard care group
    Standard care and monitoring.
    Intervention: Other: Standard care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2019)		 206
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael D. Arvig, MD +45 60869013 mdar@regionsjaelland.dk; doktorarvig@gmail.com
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04091334
Other Study ID Numbers  ICMJE REG-056-2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Slagelse Hospital
Study Sponsor  ICMJE Slagelse Hospital
Collaborators  ICMJE
  • Odense University Hospital
  • Holbaek Sygehus
  • Zealand University Hospital
  • Horsens Hospital
  • Herning Hospital
  • Hvidovre University Hospital
Investigators  ICMJE
Principal Investigator: Michael D. Arvig, MD Dept. of Emergency Medicine, Slagelse Hospital
PRS Account Slagelse Hospital
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP