Clinical trial NCT06464289: Surgical Stabilisation of Rib Fractures in Non-ventilated Patients
Official title: 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))
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rib Fractures
Thorax; Fracture
Keywords: surgical stabilisation of rib fractures
non-ventilator-dependent
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: TraumaRegister® DGU
First posted: 2024-06-18
Enrollment: 35974
Sex: ALL
Minimum age (years): 10
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients within the dataset of the TraumaRegister DGU

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.


Eligibility criteria: 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

Primary outcomes:
measure: In-hospital mortality
timeFrame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
measure: Duration of mechanical ventilation
timeFrame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
measure: Duration of intensive care unit stay.
timeFrame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Secondary outcomes:
measure: Proportion of patients intubated at any time
timeFrame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
measure: Duration of hospital stay
timeFrame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
measure: Rate of single organ failure
timeFrame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
measure: Rate of multiorgan failure
timeFrame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
measure: Rate of respiratory failure
timeFrame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
measure: Rate of sepsis
timeFrame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
measure: Clinical outcome
timeFrame: At the time of initial hospital discharge or death, whichever came first, assessed up to 2 month.
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Department for trauma, hand and reconstructive surgery, University hospital Muenster
state: NRW
Study officials:
affiliation: Department for trauma, hand and reconstructive surgery, University hospital Muenster
name: Steffen Rosslenbroich, PD Dr. med.
role: STUDY_DIRECTOR
References: