Chest TraumaNCT01134744
Evaluating Validity of Clinical Criteria for Requesting Chest X-Rays in Trauma Patients
An observational study of Chest Trauma, run by Isfahan University of Medical Sciences at 2 sites in Iran.
Trial summary
The purpose of this study is to identify the clinical criteria for requesting a chest x-ray in a patient with blunt trauma and its findings such as clinical signs with a high sensitivity could be used in a larger study to codify the final criteria. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chest Trauma
- How many people
- 385 participants
- Where
- 2 sitesIran
- Study dates
- Oct 2006to Oct 2007
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Three hundred and eighty six
Who may be able to join
- Every patient with blunt trauma to chest
Who cannot join
- nothing
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Al-zahra university hospital
Isfahan, 0311
Emamkhomeini University Hospital
Tehran, 021
About this study
Official title: Study of Accuracy of Clinical Examination for Chest Trauma
The purpose of this study is to identify the clinical criteria for requesting a chest x-ray in a patient with blunt trauma and its findings such as clinical signs with a high sensitivity could be used in a larger study to codify the final criteria.
Read the detailed description
At present, a Chest x-ray is obtained from all trauma patients having suspicion to chest trauma. The indications for such radiographs are not well defined. This results in a large number of unnecessary chest radiographs being obtained. Our goal was to identify the clinical criteria for requesting a chest x-ray in a patient with blunt trauma and its findings such as clinical signs with a high sensitivity could be used in a larger study to codify the final criteria.
- Conditions
- Chest Trauma
- Keywords
- CXray
- Medical subject headings
- Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chest trauma | chest x-ray applied for patients with chest trauma and the manifestations compared with clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
chest pain
for Assessing the accuaracy of this outcome we evaluated this one with chest x-ray manifestation
Measured: 5 min after admision time
Secondary outcomes (3)
tachypnea
for Assessing the accuaracy of this outcome we evaluated this one with chest x-ray manifestation
Measured: 5 min after admision time
abrasion
for Assessing the accuaracy of this outcome we evaluated this one with chest x-ray manifestation
Measured: 5 min after admision time
crepitation
for Assessing the accuaracy of this outcome we evaluated this one with chest x-ray manifestation
Measured: 5 min after admision time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startOct 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest TraumaStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- hamidreza shemshaki, MD, Study chair, MD,research comittee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134744
- Sponsor's protocol ID
- ASD-1213-3
- Status last verified
- Oct 2006
- First submitted
- 27 May 2010
- Last updated
- 22 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Accuracy of Clinical Examination for Chest Trauma
- ClinicalTrials.gov ID
- NCT01134744
- Acronym / sponsor ID
- ASD-1213-3
- Conditions
- Chest Trauma
- Keywords
- CXray
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 2 Jun 2010 (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 identify the clinical criteria for requesting a chest x-ray in a patient with blunt trauma and its findings such as clinical signs with a high sensitivity could be used in a larger study to codify the final criteria.
Detailed description
At present, a Chest x-ray is obtained from all trauma patients having suspicion to chest trauma. The indications for such radiographs are not well defined. This results in a large number of unnecessary chest radiographs being obtained. Our goal was to identify the clinical criteria for requesting a chest x-ray in a patient with blunt trauma and its findings such as clinical signs with a high sensitivity could be used in a larger study to codify the final criteria.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chest trauma | – | –chest x-ray applied for patients with chest trauma and the manifestations compared with clinical examination |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Three hundred and eighty six
Key inclusion criteria (1 listed)
- Every patient with blunt trauma to chest
Key exclusion criteria (1 listed)
- nothing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
chest pain
Time frame: 5 min after admision time
for Assessing the accuaracy of this outcome we evaluated this one with chest x-ray manifestation
3 secondary outcomes
tachypnea
Time frame: 5 min after admision time
abrasion
Time frame: 5 min after admision time
crepitation
Time frame: 5 min after admision time
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 22 Jun 2010.
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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.
hamidreza shemshaki, MD study chair
MD,research comittee
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Trauma, run by Isfahan University of Medical Sciences at 2 sites in Iran.
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 1 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 22 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. 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?
chest pain (time frame: 5 min after admision time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2010.