Polytraumatises With Rib Fractures Clinical Trial
— EMVOLSOfficial title:
Medico-Economic Analysis of Management of Flail Chest Between Medical Treatment and Surgical Treatment With Stracos
Optimize the management of polytraumatises with flail chest: surgical treatment Stracos by decreasing the length of stay and the late complications: pain chronicles, quality of life, respiratory function
| Status | Recruiting |
| Enrollment | 310 |
| Est. completion date | December 2020 |
| Est. primary completion date | November 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Patients with flail chest including bifocal fracture of three or more consecutive ribs in at least two places with or without paradoxical movement - The surgical procedure was performed in the first 48 hours after admission - pathology with prognosis for survival 6-month-old inferior Exclusion Criteria: - Paraplegia or Tetraplegia - Patients having the necessity of neurosurgical treatment or reanimation of neurosurgical - Aorta hematoma or rupture - ß-HCG positive in women - titanium allergy |
| Country | Name | City | State |
|---|---|---|---|
| France | Hospital University of Poitiers | Poitiers |
| Lead Sponsor | Collaborator |
|---|---|
| Poitiers University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Average cost hospitalization | Average cost hospitalization without the intensive care cost.The cost of the hospitalization will be calculated by adding the cost of the surgery and hospital stay- time of the surgery-The number of Stracos used by patient | 4 weeks | |
| Secondary | length of hospital stays of the intensive care department | From the first day to the last day in the intensive care department. Care department - monitoring patients with traumatic hemothorax - lung pulmonary infectious associated - | 4 weeks | |
| Secondary | length of hospital stays | From the first day to the last day in the hospital | 4 weeks | |
| Secondary | occurence of pulmonary infection | 12 months of follow up | ||
| Secondary | The vital capacity (VC) | Volume measurement (L) | visit 3 months, visit 6 months, visit 12 months after the surgery | |
| Secondary | The expiratory reserve volume (ERV) | Volume measurement (L) | visit 3 months, visit 6 months, visit 12 months after the surgery | |
| Secondary | The total lung capacity (TLC) | Volume measurement (L) | visit 3 months, visit 6 months, visit 12 months after the surgery | |
| Secondary | Residual volume (RV) | Volume measurement (L) | visit 3 months, visit 6 months, visit 12 months after the surgery | |
| Secondary | 6 min walk test (6MWT) | Distance measurement (M) | visit 3 months, visit 6 months, visit 12 months after the surgery | |
| Secondary | Visual analog scorer for pain | at visit 7 days, 28 days, 3 months, 6 months and 12 months | ||
| Secondary | Patient Global Assessment to measure quality of life | at visit 7 days, 28 days, 3 months, 6 months and 12 months | ||
| Secondary | date of return to work | visit 3 months, 6 months and 12 months |