Chest TraumachesttraumaNCT03686579
Chest Trauma :Prediction of Thoracic Injuries Clinically and Radiologically
An observational study of Chest Trauma and Fluid Balance; Disorder, run by Assiut University.
Trial summary
Trauma is a major cause of morbidity and mortality worldwide. Despite the advent of specialized trauma centers the outcome of patients who sustain major trauma remains disappointing. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chest Trauma, Fluid Balance; Disorder
- What is being tested?
- chest trauma
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 1 Dec 2020
- 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: Information collected by this study may contribute to the care of patients in the future who have the same lesions as those that participate in this study. The information may also improve the future management of study participants. On the other hand patients will benefit from the clinical and radiological follow up postoperatively. There are no known risks associated with participation in this study. Patients' treatment and follow up will not be altered by any means
Who may be able to join
- chest trauma 2. recent trauma: presented within48 h
Who cannot join
- Old trauma more than 48h 2-Pt transferred urgently to operating room
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Chest Trauma:Prediction of Associated Thoracic Injuries by Clinical and Radiological Studies .Specificity and Sensitivity
- Trauma is a major cause of morbidity and mortality worldwide. Despite the advent of specialized trauma centers the outcome of patients who sustain major trauma remains disappointing. Plain radiography and more advanced imaging techniques such as ultrasound, computerised tomography (CT) and angiography, have a major role to play in the early decision making and subsequent management of patients who sustain polytrauma. This article discusses the choice of emergency imaging techniques available in chest trauma for clinicians and radiologists; their evaluation and some of the common pitfalls that may lead to errors of interpretation.
Read the detailed description
Imaging plays a key role for both, the primary diagnostic work-up, and the secondary assessment of potential treatment. Despite its well-known limitations, the posteroanterior chest radiograph remains the starting point of the imaging work-up. Adjunctive imaging with computed tomography, that recently is increasingly often performed on multidetector computed tomography units, adds essential information not readily available on the conventional radiograph. This allows better definition of trauma-associated thoracic injuries not only in acute traumatic aortic injury, but also in pulmonary, tracheobronchial, cardiac, diaphragmal, and thoracic skeletal injuries. This article reviews common radiographic findings in patients after chest trauma, shows typical imaging features resulting from thoracic injury, presents imaging algorithms, and recalls to the reader less common but clinically relevant entities encountered in patients after thoracic trauma.
- Conditions
- Chest Trauma, Fluid Balance; Disorder
- Being tested
- chest trauma
- Medical subject headings
- Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest traumaRadiation
clinical and radiological study
| Study group | Role | What they receive |
|---|---|---|
| chest trauma | 1. Early detection and diagnosis of associated thoracic injuries .
2. decrease of costs required for investigations . 3- sensitivity and specificity of the investigations Receives: Radiation: chest trauma |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of associated thoracic injuries : fracture rib ,sternum…. etc detection of sensitivity and specificity of clinical and radiological finding detection of associated thoracic injuries : fracture rib ,sternum…. etc
prediction of associated thoracic injuries by clinical and radiological studies .specificity and sensitivity
Measured: after one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start1 Nov 2019 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
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.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, alzahraa gamal hasanein, Assiut University
- Investigators
- Alzahraa gamal hasanien sayed, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686579
- Sponsor's protocol ID
- CT
- Acronym
- chesttrauma
- Status last verified
- Apr 2019
- First submitted
- 25 Sep 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest Trauma:Prediction of Associated Thoracic Injuries by Clinical and Radiological Studies .Specificity and Sensitivity
- ClinicalTrials.gov ID
- NCT03686579
- Acronym / sponsor ID
- chesttrauma / CT
- Conditions
- Chest Trauma, Fluid Balance; Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 27 Sep 2018 (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.
- Trauma is a major cause of morbidity and mortality worldwide. Despite the advent of specialized trauma centers the outcome of patients who sustain major trauma remains disappointing. Plain radiography and more advanced imaging techniques such as ultrasound, computerised tomography (CT) and angiography, have a major role to play in the early decision making and subsequent management of patients who sustain polytrauma. This article discusses the choice of emergency imaging techniques available in chest trauma for clinicians and radiologists; their evaluation and some of the common pitfalls that may lead to errors of interpretation.
Detailed description
Imaging plays a key role for both, the primary diagnostic work-up, and the secondary assessment of potential treatment. Despite its well-known limitations, the posteroanterior chest radiograph remains the starting point of the imaging work-up. Adjunctive imaging with computed tomography, that recently is increasingly often performed on multidetector computed tomography units, adds essential information not readily available on the conventional radiograph. This allows better definition of trauma-associated thoracic injuries not only in acute traumatic aortic injury, but also in pulmonary, tracheobronchial, cardiac, diaphragmal, and thoracic skeletal injuries. This article reviews common radiographic findings in patients after chest trauma, shows typical imaging features resulting from thoracic injury, presents imaging algorithms, and recalls to the reader less common but clinically relevant entities encountered in patients after thoracic trauma.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chest trauma | – | Radiation: chest trauma1. Early detection and diagnosis of associated thoracic injuries . 2. decrease of costs required for investigations . 3- sensitivity and specificity of the investigations |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Information collected by this study may contribute to the care of patients in the future who have the same lesions as those that participate in this study. The information may also improve the future management of study participants. On the other hand patients will benefit from the clinical and radiological follow up postoperatively. There are no known risks associated with participation in this study. Patients' treatment and follow up will not be altered by any means
Key inclusion criteria (1 listed)
- chest trauma 2. recent trauma: presented within48 h
Key exclusion criteria (1 listed)
- Old trauma more than 48h 2-Pt transferred urgently to operating room
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 |
|---|---|---|
| chest traumaclinical and radiological study | Radiation | chest trauma |
Primary outcome
detection of associated thoracic injuries : fracture rib ,sternum…. etc detection of sensitivity and specificity of clinical and radiological finding detection of associated thoracic injuries : fracture rib ,sternum…. etc
Time frame: after one week
prediction of associated thoracic injuries by clinical and radiological studies .specificity and sensitivity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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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.
Alzahraa gamal hasanien sayed principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Trauma and Fluid Balance; Disorder, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Mohamed abdel elwhab (01222442156, draliabdelwahab@Yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of associated thoracic injuries : fracture rib ,sternum…. etc detection of sensitivity and specificity of clinical and radiological finding detection of associated thoracic injuries : fracture rib ,sternum…. etc (time frame: after one week). 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 16 Apr 2019.