Clinical trial NCT01486394: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dyspnoea
Chest Pain
Cough
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2011-12-06
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: The number of patients with a correct presumptive diagnosis within 4 hours after hospital admission.
timeFrame: 4 hours after hospital admission
Secondary outcomes:
measure: Number of patients with a correct presumptive diagnosis after primary evaluation in the control group and after sonography in the intervention group.
timeFrame: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
measure: Sensitivity, specificity, positive predictive values, negative predictive values and diagnostic accuracy of the primary evaluation and the "4-hour" presumptive diagnosis.
timeFrame: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
measure: Number of patients receiving appropriate, inappropriate and no specific treatment 4-hours after admission
timeFrame: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
measure: 30 day mortality
timeFrame: 30 days after the patient has been admitted to the hospital
measure: In-hospital mortality
timeFrame: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
measure: Number of patients transferred to an intensive care unit
timeFrame: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
measure: 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
timeFrame: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
measure: Time to diagnostic / therapeutic thoracocentesis
timeFrame: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
measure: Length of hospital stay
timeFrame: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Fyn
Study officials:
affiliation: Odense University Hospital
name: Christian B Laursen, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.