S22.5
Conditions
Interventions
Group 1: Osteosynthesis of unstable thoracic injury within 72 hours after the accident, followed by inpatient therapy according to current internal clinical standards.
Group 2: Conservative inpatient
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Adult patients = 18 years old 2) Radiological evidence of an unstable thorax, defined as: 2.1) = 3 consecutive ribs, each with a segmental fracture (= 2 fracture sites) 3) Possibility of surgical intervention within 72 hours of admission
Exclusion criteria
Exclusion criteria: 1) Comorbidities or additional injuries that preclude surgical intervention within the aforementioned timeframe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of invasive ventilation [days] during the inpatient treatment period. The individual periods of invasive ventilation are summed over the entire inpatient stay. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in individual immune profile # Duraclone™ Panels: Basic phenotyping (CD16, CD56, CD19, CD14, CD4, CD8, CD3, CD45), T-cell phenotyping (CD45RA, CD197, CD28, CD279, CD27, CD4, CD8, CD3, CD57, CD45), and B-cell phenotyping (IgD, CD21, CD19, CD27, CD24, CD38, IgM, CD45) # Multiplex ligand assays (TNF-a, G-CSF, IFN-?, IL-6, IL-10, TGF-ß, IL-8 total; sVCAM, sE-selectin, sICAM, SDF-1a, VEGF isoforms, NT-pro-BNP, and ESM1) - Incidence of injury-associated nosocomial pneumonia - Analgesic requirement measured in morphine equivalent daily dose - Duration of non-invasive ventilation - Rate of re-intubations - Rate of tracheotomies - Rate of readmission to ICU after transfer to general ward - Rate of recurrent pneumothorax after removal of inserted chest drain - Outpatient follow-up: Promis-29, SF-36, EG-5D, SF-12, Hannover Score for Polytrauma Outcome (HASPOC), Polytrauma Outcome (POLO) chart, Trauma Outcome Profile (TOP), Sickness Impact Profile (SIP), Quality of Well-Being (QWB) scale, Nottingham Health Profile (NHP), Life Satisfaction Checklist (LiSat-9, LiSat-11), Quality of Life after Brain Injury (QOLIBRI), Trauma-specific QoL questionnaire (T-QoL), The Classification of Disability by the International Classification of Impairment, Disabilities, and Handicaps, Hadorn's QoL and Health Questionnaire, St. George’s Respiratory Questionnaire, RAND-36 | — |
Countries
Germany
Contacts
Public ContactMarcel Niemann
Charité - Universitätsmedizin Berlin
Outcome results
None listed