Sonography in an Unselected Population of Acute Admitted Patients With Respiratory Symptoms

Not Applicable

Completed

• Conditions: Dyspnoea; Chest Pain; Cough
• Interventions: Other: Focused Sonography of the heart, lungs and deep veins

• Registration Number: NCT01486394
• Lead Sponsor: Odense University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-01
• Study First Submitted QC: 2011-12-02
• Study First Posted: 2011-12-06
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-02
• Last Update Posted: 2013-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 315

Inclusion Criteria

Not provided

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Exclusion Criteria

One of the following:

1. The sonographic examination can not be performed within 1 hour after the primary evaluation
2. The patient is 17 years or younger
3. The patient not able or willing to give informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Focused sonography	Focused Sonography of the heart, lungs and deep veins	Intervention group: After the primary evaluation by a physician in the emergency department, focused sonography of the patients heart, lungs and deep veins in the legs are performed. Hereafter the further examinations and treatment are done according to hospital guidelines.

Primary Outcome Measures

Name	Time	Method
The number of patients with a correct presumptive diagnosis within 4 hours after hospital admission.	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Fyn, Denmark