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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01486394
Enrollment
315
Registered
2011-12-06
Start date
2011-12-31
Completion date
2013-04-30
Last updated
2013-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Pain, Cough, Dyspnoea

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.

Interventions

OTHERFocused Sonography of the heart, lungs and deep veins

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.

Sponsors

University of Southern Denmark
CollaboratorOTHER
Odense University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All 4 of the following must be present: 1. The sonographic examination can be performed before or within 1 hour after the primary evaluation 2. Patient is 18 years or older 3. Patient able and willing to give informed consent 4. 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: 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

Design outcomes

Primary

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

MeasureTime frame
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 admissionParticipants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
30 day mortality30 days after the patient has been admitted to the hospital
In-hospital mortalityParticipants 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
Number of patients given an appropriate, inappropriate and no specific treatment after primary evaluation in the control group and after sonography in the intervention groupParticipants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
Time to diagnostic / therapeutic thoracocentesisParticipants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
Length of hospital stayParticipants 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 unitParticipants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026