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

NCT ID: NCT01486394

Last Updated: 2013-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-04-30

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.

Detailed Description

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Conditions

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Dyspnoea Chest Pain Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Focused sonography

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.

Group Type EXPERIMENTAL

Focused Sonography of the heart, lungs and deep veins

Intervention Type OTHER

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.

Usual treatment and diagnostic work-up

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Focused 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christian Borbjerg Laursen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian B Laursen, M.D

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

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Odense University Hospital

Odense, Fyn, Denmark

Site Status

Countries

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Denmark

References

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Laursen CB, Sloth E, Lassen AT, Christensen Rd, Lambrechtsen J, Madsen PH, Henriksen DP, Davidsen JR, Rasmussen F. Point-of-care ultrasonography in patients admitted with respiratory symptoms: a single-blind, randomised controlled trial. Lancet Respir Med. 2014 Aug;2(8):638-46. doi: 10.1016/S2213-2600(14)70135-3. Epub 2014 Jul 3.

Reference Type DERIVED
PMID: 24998674 (View on PubMed)

Laursen CB, Sloth E, Lassen AT, Christensen RD, Lambrechtsen J, Madsen PH, Henriksen DP, Davidsen JR, Rasmussen F. Focused sonographic examination of the heart, lungs and deep veins in an unselected population of acute admitted patients with respiratory symptoms: a protocol for a prospective, blinded, randomised controlled trial. BMJ Open. 2012 May 30;2(3):e001369. doi: 10.1136/bmjopen-2012-001369. Print 2012.

Reference Type DERIVED
PMID: 22649177 (View on PubMed)

Other Identifiers

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S-2010074

Identifier Type: -

Identifier Source: org_study_id