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Completed

NCT Number: NCT06464289

Surgical Stabilisation of Rib Fractures in Non-ventilated Patients

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.

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Key information

Conditions

Rib Fractures Fractures, Bone Thoracic Injuries Thorax; Fracture Wounds and Injuries

Age range

10 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department for trauma, hand and reconstructive surgery, University hospital Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical stabilisation of rib fractures (SSRF)

Procedure

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).

Non-operative management of rib fractures

Other

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.

Primary outcomes

  1. In-hospital mortality

    Time frame: 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

  2. Duration of mechanical ventilation

    Time frame: 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

  3. Duration of intensive care unit stay.

    Time frame: 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 outcomes

  1. Proportion of patients intubated at any time

    Time frame: 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

  2. Duration of hospital stay

    Time frame: 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

  3. Rate of single organ failure

    Time frame: 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

  4. Rate of multiorgan failure

    Time frame: 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

  5. Rate of respiratory failure

    Time frame: 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

  6. Rate of sepsis

    Time frame: 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

  7. Clinical outcome

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Collaborators

  • TraumaRegister® DGU

Registry information

Official study 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))

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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