Back to resultsSonography in an Unselected Population of Acute Admitted Patients With Respiratory Symptoms
Primary Purpose
Dyspnoea, Chest Pain, Cough
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Focused Sonography of the heart, lungs and deep veins
Sponsored by
About this trial
This is an interventional diagnostic trial for Dyspnoea
Eligibility Criteria
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
Sites / Locations
- Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Focused sonography
Usual treatment and diagnostic work-up
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Number of patients with a correct presumptive diagnosis after primary evaluation in the control group and after sonography in the intervention group.
Sensitivity, specificity, positive predictive values, negative predictive values and diagnostic accuracy of the primary evaluation and the "4-hour" presumptive diagnosis.
Number of patients receiving appropriate, inappropriate and no specific treatment 4-hours after admission
30 day mortality
In-hospital mortality
Number of patients transferred to an intensive care unit
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
Time to diagnostic / therapeutic thoracocentesis
Length of hospital stay
Full Information
NCT ID
NCT01486394
First Posted
December 1, 2011
Last Updated
August 2, 2013
Sponsor
Odense University Hospital
Collaborators
University of Southern Denmark
1. Study Identification
Unique Protocol Identification Number
NCT01486394
Brief Title
Sonography in an Unselected Population of Acute Admitted Patients With Respiratory Symptoms
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
University of Southern Denmark
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnoea, Chest Pain, Cough
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
315 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Focused sonography
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual treatment and diagnostic work-up
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Focused Sonography of the heart, lungs and deep veins
Intervention Description
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.
Primary Outcome Measure Information:
Title
The number of patients with a correct presumptive diagnosis within 4 hours after hospital admission.
Description
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).
Time Frame
4 hours after hospital admission
Secondary Outcome Measure Information:
Title
Number of patients with a correct presumptive diagnosis after primary evaluation in the control group and after sonography in the intervention group.
Time Frame
Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
Title
Sensitivity, specificity, positive predictive values, negative predictive values and diagnostic accuracy of the primary evaluation and the "4-hour" presumptive diagnosis.
Time Frame
Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
Title
Number of patients receiving appropriate, inappropriate and no specific treatment 4-hours after admission
Time Frame
Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
Title
30 day mortality
Time Frame
30 days after the patient has been admitted to the hospital
Title
In-hospital mortality
Time Frame
Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
Title
Number of patients transferred to an intensive care unit
Time Frame
Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
Title
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
Time Frame
Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
Title
Time to diagnostic / therapeutic thoracocentesis
Time Frame
Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
Title
Length of hospital stay
Time Frame
Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian B Laursen, M.D
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense
State/Province
Fyn
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
24998674
Citation
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.
Results Reference
derived
PubMed Identifier
22649177
Citation
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.
Results Reference
derived
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Sonography in an Unselected Population of Acute Admitted Patients With Respiratory Symptoms
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