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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Dyspnoea, Chest Pain, Cough

Intervention / Treatment
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* Other: Focused Sonography of the heart, lungs and deep veins


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: All 4 of the following must be present: The sonographic examination can be performed before or within 1 hour after the primary evaluation Patient is 18 years or older Patient able and willing to give informed consent One ore more of the following symptoms or clinical findings at admission to the emergency department Respiratory rate > 20 breaths per minute Saturation < 95% Oxygen therapy initiated The patient has a principal complaint of dyspnoea The patient has a principal complaint of coughing The patient has a principal complaint of chest pain 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Focused sonography<br>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. | Other: Focused Sonography of the heart, lungs and deep veins<br>* The patient is randomised to either a control group where usual treatment and diagnostic work-up is performed or to an intervention group where usual treatment and diagnostic workup are supplemented by a sonographic examination of the heart, lungs and deep veins are performed within one hour after the primary evaluation. The primary evaluation is defined as the first evaluation of the patient by a physician in the Acute Medical Admission Department.<br>|
| No Intervention: Usual treatment and diagnostic work-up<br>Control group: After the primary evaluation by a physician in the emergency department. Hereafter the further examinations and treatment are done according to hospital guidelines. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with a correct presumptive diagnosis within 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). | 4 hours after hospital admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |