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

This study is currently recruiting participants.
Verified July 2012 by Odense University Hospital
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Christian Borbjerg Laursen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01486394
First received: December 1, 2011
Last updated: July 16, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Dyspnoea
Chest Pain
Cough
 Other: Focused Sonography of the heart, lungs and deep veins

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • The number of patients with a correct presumptive diagnosis within 4 hours after hospital admission. [ Time Frame: 4 hours after hospital admission ] [ Designated as safety issue: No ]
    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. [ Time Frame: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 30 day mortality [ Time Frame: 30 days after the patient has been admitted to the hospital ] [ Designated as safety issue: No ]
  • In-hospital mortality [ Time Frame: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486394

Contacts
Contact: Christian B Laursen, M.D. +453023114 christian.b.laursen@ouh.regionsyddanmark.dk

Locations
Denmark
Odense University Hospital Recruiting
Odense, Fyn, Denmark, 5000
Contact: Christian B Laursen, M.D.     +4530231114     christian.b.laursen@ouh.regionsyddanmark    
Principal Investigator: Christian B Laursen, M.D.            
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
Investigators
Principal Investigator: Christian B Laursen, M.D Odense University Hospital
  More Information

No publications provided

Responsible Party: Christian Borbjerg Laursen, Principal Investigator, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01486394     History of Changes
Other Study ID Numbers: S-2010074
Study First Received: December 1, 2011
Last Updated: July 16, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Chest Pain
Dyspnea
Signs and Symptoms, Respiratory
Pain
 Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013