Focused Sonographic Examination of the Heart, Lungs and Deep Veins in an Unselected Population of Acute Admitted Patients With Respiratory Symptoms: a Randomised Clinical Trial

Odense University Hospital1 site in 1 country315 target enrollmentDecember 2011

ConditionsDyspnoea Chest Pain Cough

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dyspnoea
Sponsor: Odense University Hospital
Enrollment: 315
Locations: 1
Primary Endpoint: The number of patients with a correct presumptive diagnosis within 4 hours after hospital admission.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether focused sonography of the heart, lungs and deep veins can increase the number of patients with respiratory symptoms correctly diagnosed in an emergency department.

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

April 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Odense University Hospital

Responsible Party

Principal Investigator

Christian Borbjerg Laursen

Principal Investigator

Odense University Hospital

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•One of the following:
•The sonographic examination can not be performed within 1 hour after the primary evaluation
•The patient is 17 years or younger
•The patient not able or willing to give informed consent

Outcomes

Primary Outcomes

The number of patients with a correct presumptive diagnosis within 4 hours after hospital admission.

Time Frame: 4 hours after hospital admission

The 4-hour presumptive diagnosis are compared to the final diagnosis obtained by audit after the patient has been discharged from the hospital (gold standard).

Secondary Outcomes

Number of patients transferred to an intensive care unit(Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks)
Number of patients given an appropriate, inappropriate and no specific treatment after primary evaluation in the control group and after sonography in the intervention group(Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks)
Number of patients with a correct presumptive diagnosis after primary evaluation in the control group and after sonography in the intervention group.(Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks)
Sensitivity, specificity, positive predictive values, negative predictive values and diagnostic accuracy of the primary evaluation and the "4-hour" presumptive diagnosis.(Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks)
Number of patients receiving appropriate, inappropriate and no specific treatment 4-hours after admission(Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks)
30 day mortality(30 days after the patient has been admitted to the hospital)
In-hospital mortality(Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks)
Time to diagnostic / therapeutic thoracocentesis(Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks)
Length of hospital stay(Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks)