DyspnoeaNCT01486394
Sonography in an Unselected Population of Acute Admitted Patients With Respiratory Symptoms
A study testing Focused Sonography of the heart, lungs and deep veins in people with Dyspnoea and Chest Pain, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnoea, Chest Pain, Cough
- What is being tested?
- Focused Sonography of the heart, lungs and deep veins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Dyspnoea, Chest Pain, Cough
- Being tested
- Focused Sonography of the heart, lungs and deep veins
- Medical subject headings
- Dyspnea, Chest Pain, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused Sonography of the heart, lungs and deep veinsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Focused sonography | Experimental | 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. Receives: Other: Focused Sonography of the heart, lungs and deep veins |
| Usual treatment and diagnostic work-up | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with a correct presumptive diagnosis within 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).
Measured: 4 hours after hospital admission
Secondary outcomes (9)
Number of patients with a correct presumptive diagnosis after primary evaluation in the control group and after sonography in the intervention group.
Measured: 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.
Measured: 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
Measured: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
30 day mortality
Measured: 30 days after the patient has been admitted to the hospital
In-hospital mortality
Measured: 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
Measured: 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
Measured: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
Time to diagnostic / therapeutic thoracocentesis
Measured: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
Length of hospital stay
Measured: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DyspnoeaStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, Christian Borbjerg Laursen, Odense University Hospital
- Investigators
- Christian B Laursen, M.D, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486394
- Sponsor's protocol ID
- S-2010074
- Status last verified
- Aug 2013
- First submitted
- 1 Dec 2011
- Last updated
- 5 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24998674Laursen 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.
PubMed 22649177
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01486394
- Acronym / sponsor ID
- S-2010074
- Conditions
- Dyspnoea, Chest Pain, Cough
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- Dec 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 6 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focused sonography | Experimental | Other: Focused Sonography of the heart, lungs and deep veinsIntervention 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. |
| Usual treatment and diagnostic work-up | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused Sonography of the heart, lungs and deep veinsThe 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. | Other | Focused sonography |
Primary outcome
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).
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2013.
- Derived from this study: PubMed 24998674Laursen 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.
- Derived from this study: PubMed 22649177Laursen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian B Laursen, M.D principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused Sonography of the heart, lungs and deep veins in people with Dyspnoea and Chest Pain, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01486394, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2013.