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

NCT01486394 | Completed

• 1 other identifier: S-2010074
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspnoea; Chest Pain; Cough

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

Focused sonography

EXPERIMENTAL

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

Usual treatment and diagnostic work-up

NO INTERVENTION

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.

Interventions

Focused Sonography of the heart, lungs and deep veins 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.

Focused sonography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Southern Denmark: collaborator

Study Sites (1)

Odense University Hospital

Odense, Fyn, 5000, Denmark

Location

Related Publications (2)

• 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.

  PMID: 24998674 DERIVED

• 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.

  PMID: 22649177 DERIVED

MeSH Terms

Conditions

Dyspnea; Chest Pain; Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Study Officials

• Christian B Laursen, M.D

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: December 6, 2011
• Study Start: December 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 5, 2013

Record last verified: 2013-08

Locations

DK (1)