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

October 5, 2021 updated by: Slagelse Hospital

Monitoring Patients With Acute Dyspnea With Serial Focused Ultrasound of the Heart and the Lungs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

206

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Denmark
      • Horsens, Denmark
        • Department of Emergency Medicine
    • Region Zealand
      • Slagelse, Region Zealand, Denmark, 4200
        • Department of Emergency Medicine

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

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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
Active Comparator: Standard care group
Standard care and monitoring.
Other: Standard care
Standard care and evaluation and monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed within 1 hour from arrival, again after two, four hours and five hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lenght of stay
Time Frame: Assessed after 30 days from inclusion of the last patient.
Number of days the patients is admitted.
Assessed after 30 days from inclusion of the last patient.
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.
Assessed up to 12 months from inclusion of the last patient.
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
Assessed after 30 days from inclusion of the last patient.
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.
Assessed up to 12 months from inclusion of the last patient.
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
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
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
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
Assessed within 1 hour from arrival, again after two, four hours and five hours

Collaborators and Investigators

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

Sponsor

Slagelse Hospital

Collaborators

Odense University Hospital
Zealand University Hospital
Hvidovre University Hospital
Herning Hospital
Holbaek Sygehus
Horsens Hospital

Investigators

  • Principal Investigator: Michael D. Arvig, MD, Dept. of Emergency Medicine, Slagelse 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)

October 9, 2019

Primary Completion (Actual)

March 22, 2021

Study Completion (Actual)

March 22, 2021

Study Registration Dates

First Submitted

September 5, 2019

First Submitted That Met QC Criteria

September 13, 2019

First Posted (Actual)

September 16, 2019

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

October 5, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REG-056-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Raw data (deidentified participant data) may be made available upon request to the corresponding author.

IPD Sharing Time Frame

Data will be available within 6 months from the completion of the trial.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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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