Surgical Stabilisation of Rib Fractures in Non-ventilated Patients

Rib Fractures Clinical Trial

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))

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06464289
• Other study ID #: UKM_UCH_2024_001
• Secondary ID: 2023-007
• Status: Active, not recruiting
• Start date: April 13, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35974
• Est. completion date: September 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fractures

Intervention

Procedure:
• Surgical stabilisation of rib fractures (SSRF)
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).

Other:
• Non-operative management of rib fractures
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.

Locations

Country	Name	City	State
Germany	Department for trauma, hand and reconstructive surgery, University hospital Muenster	Münster	NRW

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	TraumaRegister® DGU

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.