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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06316375
Other study ID # STUMBL blunt chest trauma
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2024
Est. completion date April 30, 2026

Study information

Verified date March 2024
Source Assiut University
Contact Hadeer Youssef, Mbbch
Phone 01155101663
Email Hadeermahmoudsy@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date April 30, 2026
Est. primary completion date March 31, 2026
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - patients <18 years of age - patients with life threatening conditions

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
7 days
Secondary 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).
72 hours
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