Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01486394
Recruitment Status : Completed
First Posted : December 6, 2011
Last Update Posted : August 5, 2013
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Christian Borbjerg Laursen, Odense University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Dyspnoea Chest Pain Cough Other: Focused Sonography of the heart, lungs and deep veins Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : December 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The number of patients with a correct presumptive diagnosis within 4 hours after hospital admission. [ Time Frame: 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 :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 30 day mortality [ Time Frame: 30 days after the patient has been admitted to the hospital ]
  5. In-hospital mortality [ Time Frame: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01486394


Locations
Layout table for location information
Denmark
Odense University Hospital
Odense, Fyn, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
Investigators
Layout table for investigator information
Principal Investigator: Christian B Laursen, M.D Odense University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Christian Borbjerg Laursen, Principal Investigator, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01486394    
Other Study ID Numbers: S-2010074
First Posted: December 6, 2011    Key Record Dates
Last Update Posted: August 5, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Dyspnea
Chest Pain
Signs and Symptoms, Respiratory
Respiration Disorders
 Respiratory Tract Diseases
Pain
Neurologic Manifestations