Monitoring Patients With Shortness of Breath With Repeated Ultrasound Examinations
NCT ID: NCT04091334
Last Updated: 2021-10-06
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
206 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-10-09
Study Completion Date
2021-03-22
Brief Summary
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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.
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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Detailed Description
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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.
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.
Conditions
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Dyspnea
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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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.
Group Type
EXPERIMENTAL
Focused ultrasound of the lungs (FLUS) and focused cardiac ultrasound (FoCUS)
Intervention Type
DEVICE
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).
Standard care
Intervention Type
OTHER
Standard care and evaluation and monitoring
Standard care group
Standard care and monitoring.
Group Type
ACTIVE_COMPARATOR
Standard care
Intervention Type
OTHER
Standard care and evaluation and monitoring
Interventions
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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).
Intervention Type
DEVICE
Standard care
Standard care and evaluation and monitoring
Intervention Type
OTHER
Eligibility Criteria
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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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Odense University Hospital
OTHER
Sponsor Role
collaborator
Holbaek Sygehus
OTHER
Sponsor Role
collaborator
Zealand University Hospital
OTHER
Sponsor Role
collaborator
Horsens Hospital
OTHER
Sponsor Role
collaborator
Herning Hospital
OTHER
Sponsor Role
collaborator
Hvidovre University Hospital
OTHER
Sponsor Role
collaborator
Slagelse Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Michael D. Arvig, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Emergency Medicine, Slagelse Hospital
Locations
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Department of Emergency Medicine
Slagelse, Region Sjælland, Denmark
Site Status
Department of Emergency Medicine
Horsens, , Denmark
Site Status
Countries
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Denmark
References
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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, Gulic 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.
Reference Type
BACKGROUND
Arvig MD, Lassen AT, Gaede PH, Gartner SW, Falster C, Skov IR, Petersen HO, Posth S, Laursen CB. Impact of serial cardiopulmonary point-of-care ultrasound exams in patients with acute dyspnoea: a randomised, controlled trial. Emerg Med J. 2023 Oct;40(10):700-707. doi: 10.1136/emermed-2022-212694. Epub 2023 Aug 18.
Reference Type
DERIVED
Arvig MD, Lassen AT, Gaede PH, Laursen CB. Monitoring patients with acute dyspnoea with a serial focused ultrasound of the heart and the lungs (MODUS): a protocol for a multicentre, randomised, open-label, pragmatic and controlled trial. BMJ Open. 2020 Jun 3;10(6):e034373. doi: 10.1136/bmjopen-2019-034373.
Reference Type
DERIVED
Other Identifiers
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REG-056-2019
Identifier Type: -
Identifier Source: org_study_id
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