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

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.

Study Overview

• Status: Completed
• Conditions: Cough; Chest Pain; Dyspnoea
• Intervention / Treatment: Other: Focused Sonography of the heart, lungs and deep veins

• Study Type: Interventional
• Enrollment (Actual): 315
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Fyn
    • Odense, Fyn, Denmark, 5000
      • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: 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.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: University of Southern Denmark
• Investigators: Principal Investigator: Christian B Laursen, M.D, Odense University Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: December 1, 2011
• First Submitted That Met QC Criteria: December 2, 2011
• First Posted (Estimate): December 6, 2011

Study Record Updates

• Last Update Posted (Estimate): August 5, 2013
• Last Update Submitted That Met QC Criteria: August 2, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Pain; Neurologic Manifestations; Chest Pain; Dyspnea; Signs and Symptoms, Respiratory
• Other Study ID Numbers: S-2010074