Surgical Stabilisation of Rib Fractures in Non-ventilated Patients

Completed

• Conditions: Rib Fractures; Thorax; Fracture
• Interventions: Other: Non-operative management of rib fractures; Procedure: Surgical stabilisation of rib fractures (SSRF)

• Registration Number: NCT06464289
• Lead Sponsor: University Hospital Muenster

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-13
• Study First Submitted: 2024-05-31
• Study First Submitted QC: 2024-06-12
• Study First Posted: 2024-06-18
• Primary Completion: 2024-07-31
• Study Completion: 2024-09-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35974

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-operative	Non-operative management of rib fractures	Patients not receiving surgical stabilisation of rib fractures (SSRF)
Operative	Surgical stabilisation of rib fractures (SSRF)	Patients receiving surgical stabilisation of rib fractures (SSRF) by any operative technique
Operative	Non-operative management of rib fractures	Patients receiving surgical stabilisation of rib fractures (SSRF) by any operative technique

Primary Outcome Measures

Name	Time	Method
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.
In-hospital mortality	From 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 ventilation	From 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

Secondary Outcome Measures

Name	Time	Method
Rate of respiratory failure	From 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
Rate of single organ failure	From 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
Proportion of patients intubated at any time	From 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
Rate of multiorgan failure	From 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 sepsis	From 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
Clinical outcome	At the time of initial hospital discharge or death, whichever came first, assessed up to 2 month.	Clinical outcome according to the Glasgow Outcome Scale
Duration of hospital stay	From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.	Duration of the initial hospital stay in days

Trial Locations

Locations (1)

Department for trauma, hand and reconstructive surgery, University hospital Muenster; 🇩🇪 Münster, NRW, Germany