Monitoring Patients With Shortness of Breath With Repeated Ultrasound Examinations

NCT04091334 | Completed

• 1 other identifier: REG-056-2019
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 2

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.

Conditions

Dyspnea

Keywords

Dyspnea; Ultrasound; Point-of-care; Focused; Serial; Monitoring

Outcome Measures

Primary Outcomes (1)

• Change in dyspnea severity on a verbal dyspnea scale (VDS) from 0-10

  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 Outcomes (8)

• Lenght of stay

  Assessed after 30 days from inclusion of the last patient.

• Number of readmission(s)

  Assessed up to 12 months from inclusion of the last patient.

• In-hospital all-cause mortality

  Assessed after 30 days from inclusion of the last patient.

• All-cause mortality 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

  Assessed within 1 hour from arrival, again after two, four hours and five hours

Study Arms (2)

Serial ultrasound group

EXPERIMENTAL

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); Other: Standard care

Standard care group

ACTIVE COMPARATOR

Standard care and monitoring.

Other: Standard care

Interventions

Focused ultrasound of the lungs (FLUS) and focused cardiac ultrasound (FoCUS) 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).

Serial ultrasound group

Standard care OTHER

Standard care and evaluation and monitoring

Serial ultrasound group; Standard care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with dyspnea primary admitted because of a trauma

Sponsors & Collaborators

• Slagelse Hospital: lead
• Odense University Hospital: collaborator
• Holbaek Sygehus: collaborator
• Zealand University Hospital: collaborator
• Horsens Hospital: collaborator
• Herning Hospital: collaborator
• Hvidovre University Hospital: collaborator

Study Sites (2)

Department of Emergency Medicine

Slagelse, Region Sjælland, 4200, Denmark

Location

Department of Emergency Medicine

Horsens, Denmark

Location

Related Publications (27)

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MeSH Terms

Conditions

Dyspnea

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Michael D. Arvig, MD

  Dept. of Emergency Medicine, Slagelse Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 16, 2019
• Study Start: October 9, 2019
• Primary Completion: March 22, 2021
• Study Completion: March 22, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

DK (2)