Monitoring Patients With Shortness of Breath With Repeated Ultrasound Examinations

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

Interventions

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

Sponsors & Collaborators

• Odense University Hospital

  collaborator OTHER

• Holbaek Sygehus

  collaborator OTHER

• Zealand University Hospital

  collaborator OTHER

• Horsens Hospital

  collaborator OTHER

• Herning Hospital

  collaborator OTHER

• Hvidovre University Hospital

  collaborator OTHER

• Slagelse Hospital

  lead OTHER

Principal Investigators

• Michael D. Arvig, MD · Dept. of Emergency Medicine, Slagelse Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-09

Primary Completion

2021-03-22

Completion

2021-03-22

Countries

• Denmark

Study Locations