Operative Treatment of Unstable Thoracic Cage Injuries and Chest Wall Deformity in Trauma
Study Details
Study Description
Brief Summary
The purpose of this prospective controlled study is to determine whether surgical management of unstable thoracic cage injuries and chest wall deformity in trauma reduces the need for and the time spent on ventilator compared to a group treated without operation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Patients meeting the inclusion criteria and giving their informed consent will be enrolled in this prospective controlled study. Included patients at Sahlgrenska University Hospital will undergo surgical stabilization of chest wall injuries and patients at Karolinska University Hospital will be managed conservatively. A total of 60 patients will be included in each group. 3D reconstructions of computed tomography images of the Thorax done at admission to the hospital will be used in order to evaluate injury according to Lung Injury Scale and Chest wall Injury Scale and for calculating radiological lung volumes and plan surgical procedure in the intervention group. Surgery will be performed as soon as possible after inclusion. MatrixRIB® (DePuy Synthes) Fixation system is used for stabilizing rib fractures with plates and angular locked screws. In cases where thoracotomy is done the patients will receive an anterior and posterior chest tube and wound drain with active suction. All patients, both in the intervention and in the control group will be offered thoracic epidural anaesthesia. Broad-spectrum intravenous antibiotic therapy is given as long as the patient has chest tubes. Thrombotic prophylaxis with LMWH is given until the patient is mobilized but for a minimum of 7 days. Patients will be followed-up 6 weeks, 6 months and 1 year post-operatively by surgeon and physiotherapist. A low-dosage computer tomography of the thorax will be done after 6 months in order to evaluate healing of the rib cage, possible non-union or dysfunction of osteosynthetic material and measure remaining lung volume. This examination will be compared to the initial computer tomography image done when the patient was admitted. At follow-ups complaints, possible late complications, usage of analgesia and return to work will be recorded. Evaluated instruments, EQ-5D-5L, VAS with Pain-O-Meter (POM) and Disability Rating Index (DRI) will be used to evaluate quality of life, pain and physical function. Range of motion in the thorax, thoracic spine and shoulders will be evaluated for every patient. Breathing movements will be measured by using a Respiratory movement measuring instrument (RMMI, ReMo Inc) and lung function tests will be performed in a standardized manner.
In order to enrich the material, hospital data from patients fulfilling the inclusion criteria but not included, at the two study locations, during the inclusion period (June 2014
- June 2017) will be analyzed. An additional Ethical approval has been granted.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Surgical management Operative fixation of unstable thoracic cage injuries and chest wall deformity. Thoracic Epidural anaesthesia will be offered. Paracetamol, Opioids and NSAID will be used as pain medication. |
Drug: NSAID
Will be used if tolerated.
Other Names:
Drug: Opioids
Initially intravenous administration and when tolerated oral slow-release pils will be used.
Other Names:
Drug: Thoracic Epidural anaesthesia
Given by specialists in anaesthesiology and intensive care.
Other Names:
Drug: Paracetamol
1g QID will be given to all patients unless allergies.
Other Names:
Procedure: Surgical management
Fracture stabilization
Other Names:
|
| Active Comparator: Conservative management Conservative management of unstable thoracic cage injuries and chest wall deformity. Thoracic epidural anaesthesia will be offered. Paracetamol, Opioids and NSAID will be used as pain medication. |
Drug: NSAID
Will be used if tolerated.
Other Names:
Drug: Opioids
Initially intravenous administration and when tolerated oral slow-release pils will be used.
Other Names:
Drug: Thoracic Epidural anaesthesia
Given by specialists in anaesthesiology and intensive care.
Other Names:
Drug: Paracetamol
1g QID will be given to all patients unless allergies.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Respiratory insufficiency [1 year]
Need and length of ventilation therapy
Secondary Outcome Measures
- Hospital stay [6 weeks]
Time spent in an intensive care unit and total length of hospital stay
Other Outcome Measures
- Disability Rating Index [1 year]
Pain, function and mobility
- Quality of Life; EQ5D5L and VAS [Time Frame]
EQ-5D-5L instrument has a subscale of; 1 (no problems), 2 (slight problems), 3 (moderate problems), 4 (severe problems) and 5 (extreme problems). The Visual Analogue scale is a self-rating scale from 0% (the worst Health you can imagine) to 100% (the best Health you can imagine).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Trauma with segmental rib fractures on at least 3 adjacent ribs ( anatomical flail chest )
-
Trauma with chest wall deformity
Exclusion Criteria:
-
Concurrent spinal cord injuries with paralysis
-
Severe head injury where normal level of consciousness is not resumed
-
Severe neurological and musculoskeletal diseases that influence the function of the thoracic wall and lung volumes
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Departement of Surgery, Sahlgrenska University Hospital | Gothenburg | Sweden | 413 45 | |
| 2 | Departement of Intensive Care, Karolinska University Hospital | Stockholm | Sweden | 171 76 |
Sponsors and Collaborators
- Sahlgren´s University Hospital
- Sahlgrenska University Hospital, Sweden
- Karolinska University Hospital
Investigators
- Study Director: Hans Granhed, MD PhD, Sahlgrenska University Hospital, Sweden
- Principal Investigator: Eva-Corina Caragounis, MD, Sahlgrenska University Hospital, Sweden
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ec761218
- epn887-13