Surgical Stabilisation of Rib Fractures in Non-ventilated Patients
NCT Number: NCT06464289
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Rib Fractures|Thorax; Fracture
Interventions: PROCEDURE: Surgical stabilisation of rib fractures (SSRF)|OTHER: Non-operative management of rib fractures
Sponsor: University Hospital Muenster
Collaborators: TraumaRegister® DGU
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 35974
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-13
Completion Date: 2024-09-30
Locations: Department for trauma, hand and reconstructive surgery, University hospital Muenster, Münster, NRW, 48149, Germany

Summary:
The aim of the study is to investigate the effect of surgical stabilisation of rib fractures on clinical outcomes in patients that are not dependent on mechanical ventilation at the time of the treatment decision. To this end, data on all eligible patients will be extracted from the TraumaRegister® DGU. Baseline demographics will be analysed using descriptive statistics. Propensity matching will be conducted between the operative cohort (receiving SSRF by any technique) and the conservative cohort (not receiving SSRF). The effect of SSRF on the outcome variables will then be assessed using appropriate statistical tests.

Primary Outcome Measures: In-hospital mortality, Number of patients who died in the hospital and mortality rate up to hospital discharge, From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.|Duration of mechanical ventilation, The duration in hours a patient spent intubated from the time of hospital admission to the time of initial hospital discharge, From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.|Duration of intensive care unit stay., The duration in days a patient spent in the intensive care unit from the time of hospital admission to the time of initial hospital discharge., From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Secondary Outcome Measures: Proportion of patients intubated at any time, Proportion of patients intubated at any time from time of injury to initial hospital discharge, From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.|Duration of hospital stay, Duration of the initial hospital stay in days, From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.|Rate of single organ failure, The Rate of single organ failure from injury to initial hospital discharge, From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.|Rate of multiorgan failure, The Rate of multiorgan failure from injury to initial hospital discharge, From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.|Rate of respiratory failure, The Rate of respiratory failure from injury to initial hospital discharge, From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.|Rate of sepsis, The Rate of sepsis from injury to initial hospital discharge, From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.|Clinical outcome, Clinical outcome according to the Glasgow Outcome Scale, At the time of initial hospital discharge or death, whichever came first, assessed up to 2 month.