Monitoring Patients With Shortness of Breath With Repeated Ultrasound Examinations (MODUS)
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| ClinicalTrials.gov Identifier: NCT04091334 |
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Recruitment Status :
Recruiting
First Posted : September 16, 2019
Last Update Posted : March 18, 2020
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dyspnea | Device: Focused ultrasound of the lungs (FLUS) and focused cardiac ultrasound (FoCUS) Other: Standard care | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 206 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Monitoring Patients With Acute Dyspnea With Serial Focused Ultrasound of the Heart and the Lungs |
| Actual Study Start Date : | October 9, 2019 |
| Estimated Primary Completion Date : | December 2020 |
| Estimated Study Completion Date : | December 2021 |
| Arm | Intervention/treatment |
|---|---|
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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 |
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Active Comparator: Standard care group
Standard care and monitoring.
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Other: Standard care
Standard care and evaluation and monitoring |
- 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.
- 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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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091334
| Contact: Michael D. Arvig, MD | +45 60869013 | mdar@regionsjaelland.dk; doktorarvig@gmail.com |
| Denmark | |
| Department of Emergency Medicine | Recruiting |
| Slagelse, Region Zealand, Denmark, 4200 | |
| Contact: Michael D Arvig, MD 60869013 doktorarvig@gmail.com | |
| Department of Emergency Medicine | Recruiting |
| Horsens, Denmark | |
| Contact: Henrik Ømark, MD | |
| Principal Investigator: | Michael D. Arvig, MD | Dept. of Emergency Medicine, Slagelse Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Slagelse Hospital |
| ClinicalTrials.gov Identifier: | NCT04091334 |
| Other Study ID Numbers: |
REG-056-2019 |
| First Posted: | September 16, 2019 Key Record Dates |
| Last Update Posted: | March 18, 2020 |
| Last Verified: | March 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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 Statistical Analysis Plan (SAP) Informed Consent Form (ICF) 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Dyspnea Ultrasound Point-of-care |
Focused Serial Monitoring |
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Dyspnea Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |