Chest PainNCT04429698
The Effects of Point-of-care Ultrasonography
A study testing Point of care ultrasonography in people with Chest Pain, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Background: When used with standard diagnostic testing, point-of-care ultrasonography (POCUS) might improve the proportion of patients admitted with chest pain (CP) who are correctly diagnosed, decrease length of stay (LOS) in emergency department (ED) and costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain
- What is being tested?
- Point of care ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2018to 15 Jan 2019
- 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
- Patients admitted to the emergency were included in this study if they had chest pain, or chest pain with back pain, neck and jaw pain, abdominal pain, arm pain and shortness of breath
Who cannot join
- permanent mental disability
- age younger than 18 years
- having chest trauma in the last 24 hours
- to be pregnant
- need for urgent angiography with ST elevation myocardial infarction
- to be referred to the ED as a diagnosis of external center
- failure to obtain complete patient information
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University Training and Research Hospital
Sakarya, 54050
About this study
Official title: The Effects of Point-of-care Ultrasonography on the Dıagnosıs Process of Patıents Who Admıtted to Emergency Department: Randomised-Controlled Trial
Background: When used with standard diagnostic testing, point-of-care ultrasonography (POCUS) might improve the proportion of patients admitted with chest pain (CP) who are correctly diagnosed, decrease length of stay (LOS) in emergency department (ED) and costs. We therefore assessed POCUS for the heart, lungs, aortic, hepatobiliary and deep vein in addition to the usual initial diagnostic testing in this patient population.
Methods: In a prospective, randomised-controlled, parallel-group trial in the ED at Sakarya University Training and Research Hospital, Turkey, patients (≥18 years) with CP were randomly assigned in a 1:1 ratio to a standard diagnostic strategy (control group) or to standard diagnostic strategy supplemented with POCUS (POCUS group).
- Conditions
- Chest Pain
- Being tested
- Point of care ultrasonography
- Keywords
- chest pain, POCUS, length of stay, emergency department
- Medical subject headings
- Chest Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care ultrasonographyDiagnostic test
Point-of-care Ultrasonography is an imaging method performed with ultrasound aid to facilitate rapid diagnosis and interventions during emergency intervention.
| Study group | Role | What they receive |
|---|---|---|
| POCUS group | Other | Patients in this group underwent POCUS after primary clinical evaluation with the knowledge of their primary physician. This procedure was performed in the first hour after the patients' primary clinical evaluations to evaluate the predetermined parameters in the study form for the heart, lungs, hepatobiliary, aortic and deep veins. Receives: Diagnostic Test: Point of care ultrasonography |
| Control group | No intervention | All processes and results were followed without any intervention in the processes related to the patients in this group and the results were recorded in the study form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospitalization or discharge
Measured: 6 months
Average costs during the diagnosis of patients.
Measured: 6 months
Secondary outcomes (3)
The rate of change in the preliminary diagnosis of physician
Measured: 6 months
The Hospitalization rate
Measured: 6 months
The discharge rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start15 Sep 2018
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necip Gökhan Güner, Sakarya University
- Investigators
- Necip G Guner, M.D., Principal investigator, Sakarya University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429698
- Sponsor's protocol ID
- 05 of 12.09.2018
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buhumaid RE, St-Cyr Bourque J, Shokoohi H, Ma IWY, Longacre M, Liteplo AS. Integrating point-of-care ultrasound in the ED evaluation of patients presenting with chest pain and shortness of breath. Am J Emerg Med. 2019 Feb;37(2):298-303. doi: 10.1016/j.ajem.2018.10.059. Epub 2018 Oct 30.
PubMed 30413369Laursen 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 24998674Lamsam L, Gharahbaghian L, Lobo V. Point-of-care Ultrasonography for Detecting the Etiology of Unexplained Acute Respiratory and Chest Complaints in the Emergency Department: A Prospective Analysis. Cureus. 2018 Aug 28;10(8):e3218. doi: 10.7759/cureus.3218.
PubMed 30405993Elikashvili I, Tay ET, Tsung JW. The effect of point-of-care ultrasonography on emergency department length of stay and computed tomography utilization in children with suspected appendicitis. Acad Emerg Med. 2014 Feb;21(2):163-70. doi: 10.1111/acem.12319.
PubMed 24673672Lin MJ, Neuman M, Rempell R, Monuteaux M, Levy J. Point-of-Care Ultrasound is Associated With Decreased Length of Stay in Children Presenting to the Emergency Department With Soft Tissue Infection. J Emerg Med. 2018 Jan;54(1):96-101. doi: 10.1016/j.jemermed.2017.09.017. Epub 2017 Oct 27.
PubMed 29110982
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Point-of-care Ultrasonography on the Dıagnosıs Process of Patıents Who Admıtted to Emergency Department: Randomised-Controlled Trial
- ClinicalTrials.gov ID
- NCT04429698
- Acronym / sponsor ID
- 05 of 12.09.2018
- Conditions
- Chest Pain
- Keywords
- chest pain, POCUS, length of stay, emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 12 Jun 2020 (actual)
- 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.
Background: When used with standard diagnostic testing, point-of-care ultrasonography (POCUS) might improve the proportion of patients admitted with chest pain (CP) who are correctly diagnosed, decrease length of stay (LOS) in emergency department (ED) and costs. We therefore assessed POCUS for the heart, lungs, aortic, hepatobiliary and deep vein in addition to the usual initial diagnostic testing in this patient population.
Methods: In a prospective, randomised-controlled, parallel-group trial in the ED at Sakarya University Training and Research Hospital, Turkey, patients (≥18 years) with CP were randomly assigned in a 1:1 ratio to a standard diagnostic strategy (control group) or to standard diagnostic strategy supplemented with POCUS (POCUS group).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POCUS group | Other | Diagnostic Test: Point of care ultrasonographyPatients in this group underwent POCUS after primary clinical evaluation with the knowledge of their primary physician. This procedure was performed in the first hour after the patients' primary clinical evaluations to evaluate the predetermined parameters in the study form for the heart, lungs, hepatobiliary, aortic and deep veins. |
| Control group | No intervention | –All processes and results were followed without any intervention in the processes related to the patients in this group and the results were recorded in the study form |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to the emergency were included in this study if they had chest pain, or chest pain with back pain, neck and jaw pain, abdominal pain, arm pain and shortness of breath
Key exclusion criteria (7 listed)
- permanent mental disability
- age younger than 18 years
- having chest trauma in the last 24 hours
- to be pregnant
- need for urgent angiography with ST elevation myocardial infarction
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 |
|---|---|---|
| Point of care ultrasonographyPoint-of-care Ultrasonography is an imaging method performed with ultrasound aid to facilitate rapid diagnosis and interventions during emergency intervention. | Diagnostic test | POCUS group |
Primary outcome
Duration of hospitalization or discharge
Time frame: 6 months
Average costs during the diagnosis of patients.
Time frame: 6 months
3 secondary outcomes
The rate of change in the preliminary diagnosis of physician
Time frame: 6 months
The Hospitalization rate
Time frame: 6 months
The discharge rate
Time frame: 6 months
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 12 Jun 2020.
- Background: PubMed 30413369Buhumaid RE, St-Cyr Bourque J, Shokoohi H, Ma IWY, Longacre M, Liteplo AS. Integrating point-of-care ultrasound in the ED evaluation of patients presenting with chest pain and shortness of breath. Am J Emerg Med. 2019 Feb;37(2):298-303. doi: 10.1016/j.ajem.2018.10.059. Epub 2018 Oct 30.
- Results publication: 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.
- Results publication: PubMed 30405993Lamsam L, Gharahbaghian L, Lobo V. Point-of-care Ultrasonography for Detecting the Etiology of Unexplained Acute Respiratory and Chest Complaints in the Emergency Department: A Prospective Analysis. Cureus. 2018 Aug 28;10(8):e3218. doi: 10.7759/cureus.3218.
- Results publication: PubMed 24673672Elikashvili I, Tay ET, Tsung JW. The effect of point-of-care ultrasonography on emergency department length of stay and computed tomography utilization in children with suspected appendicitis. Acad Emerg Med. 2014 Feb;21(2):163-70. doi: 10.1111/acem.12319.
- Results publication: PubMed 29110982Lin MJ, Neuman M, Rempell R, Monuteaux M, Levy J. Point-of-Care Ultrasound is Associated With Decreased Length of Stay in Children Presenting to the Emergency Department With Soft Tissue Infection. J Emerg Med. 2018 Jan;54(1):96-101. doi: 10.1016/j.jemermed.2017.09.017. Epub 2017 Oct 27.
- Individual participant dataSharing planned: No
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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.
Necip G Guner, M.D. principal investigator
Sakarya University Training and Research 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 Point of care ultrasonography in people with Chest Pain, run by Sakarya University at 1 site in Turkey (Türkiye).
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 1 inclusion and 7 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 12 Jun 2020. 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 Turkey (Türkiye). 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?
Duration of hospitalization or discharge (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT04429698, which also lists 5 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 12 Jun 2020.