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

This study has been completed.
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: August 2, 2013
Last verified: August 2013

December 1, 2011
August 2, 2013
December 2011
April 2013   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01486394 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
  • Dyspnoea
  • Chest Pain
  • Cough
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.
  • 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.
    Intervention: Other: Focused Sonography of the heart, lungs and deep veins
  • 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
315
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01486394
S-2010074
No
Christian Borbjerg Laursen, Odense University Hospital
Odense University Hospital
University of Southern Denmark
Principal Investigator: Christian B Laursen, M.D Odense University Hospital
Odense University Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP