CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 206 enrolled
Drug / intervention
Focused ultrasound of the lungs (FLUS) and focused cardiac ultrasound (FoCUS) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04091334
NCT04091334N/ACompleted

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

Slagelse Hospital·interventional·Posted Sep 16, 2019·Updated Oct 6, 2021

In Brief

A clinical study evaluating Focused ultrasound of the lungs (FLUS) and focused cardiac ultrasound (FoCUS) and Standard care for Dyspnea. Completed, enrolled 206 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyspnea
CountriesDenmark

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 16, 2019
Enrollment StartOct 9, 2019
Primary CompletionMar 22, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.8 years ago

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).

Standard careother

Standard care and evaluation and monitoring