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Surgical Stabilisation of Rib Fractures in Non-ventilated Patients

Surgical Stabilisation of Rib Fractures in Non-ventilated Patients: a Retrospective Propensity-matched Analysis Using the Data From the German National Trauma Registry (TraumaRegister of the German Trauma Society (DGU))

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06464289
Enrollment
35974
Registered
2024-06-18
Start date
2024-04-13
Completion date
2024-09-30
Last updated
2024-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rib Fractures, Thorax; Fracture

Keywords

surgical stabilisation of rib fractures, non-ventilator-dependent

Brief 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.

Interventions

Surgical stabilisation of rib fractures using any fixation technique (including but not limited to plate fixation, intramedullary fixation, wire fixation) via any operative approach (including but not limited to open external approach, minimally invasive approach, thoracoscopic approach, thoracotomy approach).

Any supportive or specific treatment of rib fractures excluding surgical stabilisation of rib fractures. This includes, but is not limited to analgesia, physiotherapy, non-invasive ventilation, mechanical ventilation, oxygen-supplementation.

Sponsors

TraumaRegister® DGU
CollaboratorUNKNOWN
University Hospital Muenster
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Rib AIS of ≥ 3 * Initial hospital treatment

Exclusion criteria

* Intubated preclinically or in the emergency department * Glasgow coma scale (GCS) \< 9 at the time of the primary survey in the emergency department * No in-patient hospital management

Design outcomes

Primary

MeasureTime frameDescription
In-hospital mortalityFrom injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.Number of patients who died in the hospital and mortality rate up to hospital discharge
Duration of mechanical ventilationFrom injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.The duration in hours a patient spent intubated from the time of hospital admission to the time of initial hospital discharge
Duration of intensive care unit stay.From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.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.

Secondary

MeasureTime frameDescription
Rate of multiorgan failureFrom injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.The Rate of multiorgan failure from injury to initial hospital discharge
Rate of respiratory failureFrom injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.The Rate of respiratory failure from injury to initial hospital discharge
Proportion of patients intubated at any timeFrom injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.Proportion of patients intubated at any time from time of injury to initial hospital discharge
Clinical outcomeAt the time of initial hospital discharge or death, whichever came first, assessed up to 2 month.Clinical outcome according to the Glasgow Outcome Scale
Rate of sepsisFrom injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.The Rate of sepsis from injury to initial hospital discharge
Duration of hospital stayFrom injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.Duration of the initial hospital stay in days
Rate of single organ failureFrom injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.The Rate of single organ failure from injury to initial hospital discharge

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026