Blunt Injury of ThoraxNCT06316375
STUMBL Score as a Risk Stratification Tool for Management of Blunt Chest Trauma Patients
An observational study of Blunt Injury of Thorax, run by Assiut University.
Trial summary
The aim of this study is to assess validity of the STUMBL score in EGYPT for complications of blunt chest trauma without multi-trauma and immediate life-threatening injuries and identify patients at risk of in- hospital mortality or ICU admission and predict survival in both Assiut \& Suez Canal University Hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blunt Injury of Thorax
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 30 Apr 2026
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients with blunt chest trauma satisfying inclusion criteria and does not include exclusion criteria
Who may be able to join
- The present study will be conducted on patients of blunt chest trauma of both genders "without intently selected certain gender" and had 18 years old or more.
Who cannot join
- patients <18 years of age
- patients with life threatening conditions
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment Of STUMBL Score (STUdy of the Management of BLunt Chest Wall Trauma) As A Risk Stratification Tool In Management Of Blunt Chest Trauma Patients In Emergency Departments: A Multicenter Study
The aim of this study is to assess validity of the STUMBL score in EGYPT for complications of blunt chest trauma without multi-trauma and immediate life-threatening injuries and identify patients at risk of in- hospital mortality or ICU admission and predict survival in both Assiut \& Suez Canal University Hospitals.
Read the detailed description
The STUMBL Score (STUdy of the Management of BLunt chest wall trauma) (also referred to as the Battle score) is a clinical prediction model that was developed and externally validated in 2014 in the UK . The purpose of the model is to assist in the clinical decision-making of patients with blunt chest wall trauma (excluding those with life-threatening injuries) in the Emergency Department (ED), through the calculation of a percentage risk of complications which in turn, provides a recommended discharge disposition. The STUMBL score includes five predictors: age at attendance, number of rib fractures, chronic lung disease, use of pre-injury anticoagulants and oxygen saturation (SpO2). This is the first score to introduce clinical variables, specifically chronic lung disease and anticoagulation, in contrast to other scores which have used anatomical variables and age alone. A huge benefit of the STUMBL score is that these variables are all routinely measured in the ED. Whilst other scores exist, the STUMBL Score is the only externally validated model with excellent predictive capabilities, that can be used for adult patients of all ages with blunt chest trauma presenting to the ED, not just a specific age group or severity of injury.
Collected data will be analyzed and tabulated by using appropriate statistical methods.
Statistical analysis will be performed by the SPSS statistical software computer program version 20 (Statistical Package for Social Science), Medcalc v.11.6.and Open Epi V.3.01.
Data will be described using mean ± standard deviation (SD) and frequencies according if they are quantitative or qualitative respectively.
Parametric tests will be used in the current study if data proved to be normally distributed.
For all statistical tests, a P value less than 0.05 will be taken to indicate a significant difference.
- Conditions
- Blunt Injury of Thorax
- Keywords
- Blunt chest trauma, STUMBL score
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was to assess the validity of the STUMBL score for all complications of chest blunt trauma, originally defined by the STUMBL authors
These complications include:
- In-hospital mortality.
- All pulmonary complications (including but not restricted to haemothorax, pneumothorax, lung contusion, pneumonia, and empyema, excluding rib fractures).
- Need for ICU admission.
- Prolonged hospital stay defined as a total hospital stay of 7 days or more
Measured: 7 days
Secondary outcomes (1)
Secondary outcomes validated the STUMBL score using a composite of early and delayed complications.
Early complications:
- Presence of a pulmonary complication on arrival to ED as defined above
- Admission to ICU from ED
Delayed complications:
- Delayed pulmonary complications defined as pulmonary complications developing or discovered after discharge from the ED to the ward or community,including lung contusion,pleural effusion,empyema, hemothorax,pneumothorax,pneumomediastinum,pneumonia or pulmonary embolism.
- Delayed escalation in care,defined as a requirement for ICU admission because of chest trauma related complications at any point after discharge from the ED to the ward or community.
- Unplanned re-presentation to the ED,Patient discharged from ED on the first presentation but re-presented to ED with complications of chest trauma that was not a planned followup assessment within 72h of discharge for patients whose initial hospital stay was 1day or less (including those discharged directly from ED and those admitted to a ward for less than 2days).
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blunt Injury of ThoraxStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hadeer mahmoud saber youssef, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316375
- Sponsor's protocol ID
- STUMBL blunt chest trauma
- Status last verified
- Mar 2024
- First submitted
- 3 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of STUMBL Score (STUdy of the Management of BLunt Chest Wall Trauma) As A Risk Stratification Tool In Management Of Blunt Chest Trauma Patients In Emergency Departments: A Multicenter Study
- ClinicalTrials.gov ID
- NCT06316375
- Acronym / sponsor ID
- STUMBL blunt chest trauma
- Conditions
- Blunt Injury of Thorax
- Keywords
- Blunt chest trauma, STUMBL score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 18 Mar 2024 (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.
The aim of this study is to assess validity of the STUMBL score in EGYPT for complications of blunt chest trauma without multi-trauma and immediate life-threatening injuries and identify patients at risk of in- hospital mortality or ICU admission and predict survival in both Assiut \& Suez Canal University Hospitals.
Detailed description
The STUMBL Score (STUdy of the Management of BLunt chest wall trauma) (also referred to as the Battle score) is a clinical prediction model that was developed and externally validated in 2014 in the UK . The purpose of the model is to assist in the clinical decision-making of patients with blunt chest wall trauma (excluding those with life-threatening injuries) in the Emergency Department (ED), through the calculation of a percentage risk of complications which in turn, provides a recommended discharge disposition. The STUMBL score includes five predictors: age at attendance, number of rib fractures, chronic lung disease, use of pre-injury anticoagulants and oxygen saturation (SpO2). This is the first score to introduce clinical variables, specifically chronic lung disease and anticoagulation, in contrast to other scores which have used anatomical variables and age alone. A huge benefit of the STUMBL score is that these variables are all routinely measured in the ED. Whilst other scores exist, the STUMBL Score is the only externally validated model with excellent predictive capabilities, that can be used for adult patients of all ages with blunt chest trauma presenting to the ED, not just a specific age group or severity of injury.
Collected data will be analyzed and tabulated by using appropriate statistical methods.
Statistical analysis will be performed by the SPSS statistical software computer program version 20 (Statistical Package for Social Science), Medcalc v.11.6.and Open Epi V.3.01.
Data will be described using mean ± standard deviation (SD) and frequencies according if they are quantitative or qualitative respectively.
Parametric tests will be used in the current study if data proved to be normally distributed.
For all statistical tests, a P value less than 0.05 will be taken to indicate a significant difference.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients with blunt chest trauma satisfying inclusion criteria and does not include exclusion criteria
Key inclusion criteria (1 listed)
- The present study will be conducted on patients of blunt chest trauma of both genders "without intently selected certain gender" and had 18 years old or more.
Key exclusion criteria (2 listed)
- patients <18 years of age
- patients with life threatening conditions
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
The primary outcome was to assess the validity of the STUMBL score for all complications of chest blunt trauma, originally defined by the STUMBL authors
Time frame: 7 days
These complications include: * In-hospital mortality. * All pulmonary complications (including but not restricted to haemothorax, pneumothorax, lung contusion, pneumonia, and empyema, excluding rib fractures). * Need for ICU admission. * Prolonged hospital stay defined as a total hospital stay of 7 days or more
1 secondary outcome
Secondary outcomes validated the STUMBL score using a composite of early and delayed complications.
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
Related trials for Blunt Injury of Thorax
Not yet recruitingObservational study
Medical,Nursing Record,PE, Blood Test and Radiological Examination ,Morality and Mobility of Multiple Trauma Patient
Trauma Centers/Statistics & Numerical Data, Trauma Blunt
Active, not recruiting
Effectiveness of an Innovative Chest Stabilizer in Rib Fracture Treatment: Impact on Respiratory Function, Complications, and Clinical Outcomes
Rib Fractures, Blunt Chest Trauma
RecruitingObservational study
GNRI and PNI for Predicting Short-Term Outcomes in Older Adults With Multiple Rib Fractures
Multiple Rib Fractures, Isolated Blunt Thoracic Trauma
Not yet recruitingObservational study
Combined Lung and Diaphragmatic Ultrasound to Predict Respiratory Failure in Blunt Chest Trauma
Blunt Chest Trauma, Respiratory Failure
RecruitingObservational study
Validation of the STUMBL Score for Blunt Thoracic Trauma
Chest Trauma
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Blunt Injury of Thorax, 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 2 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 27 Mar 2024. 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 Hadeer Youssef, Mbbch (01155101663 ext. +20, Hadeermahmoudsy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was to assess the validity of the STUMBL score for all complications of chest blunt trauma, originally defined by the STUMBL authors (time frame: 7 days). 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 27 Mar 2024.