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Sonography in an Unselected Population of Acute Admitted Patients With Respiratory Symptoms
This study has been completed.
Sponsor:
Odense University Hospital
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
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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 (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:
Further study details as provided by Christian Borbjerg Laursen, 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 ]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 ]
- 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 ]
- 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 ]
- 30 day mortality [ Time Frame: 30 days after the patient has been admitted to the hospital ]
- In-hospital mortality [ Time Frame: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
| Enrollment: | 315 |
| Study Start Date: | December 2011 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2013 (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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486394
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486394
Locations
| Denmark | |
| Odense University Hospital | |
| Odense, Fyn, Denmark, 5000 | |
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
Investigators
| Principal Investigator: | Christian B Laursen, M.D | Odense University Hospital |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | August 2, 2013 |
Additional relevant MeSH terms:
|
Dyspnea Chest Pain Signs and Symptoms, Respiratory Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms Pain Neurologic Manifestations Nervous System Diseases |
ClinicalTrials.gov processed this record on August 17, 2017