Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT03487458
Eligibility Criteria:
Inclusion Criteria:
Absolute Indications:
1. Flail chest with paradoxical respiration
2. Multiple rib fractures with uncontrolled hemothorax or pneumothorax
3. Severe thoracic trauma causing respiratory failure (ex poor blood oxygen saturation, hypercapnia, overtime intubation etc.)
Relative Indications:
1. Fractures of 3 or more ribs, with moderate amount of hemothorax or pneumothorax
2. Fractures of 3 or more ribs, with clavicle or scapula fractures, requiring surgical intervention
3. Fractures of 3 or more ribs, with obvious rib displacement and pain
4. Chronic neuropathic pain, with poor drug control
5. Symptoms due to poor healing of fracture site (ex. dyspnea or restrictive lung disease)
6. Chest deformity or other cosmetic factors
7. Other personal factors (ex. disability caused by rib fractures)
Exclusion Criteria:
1. High risk for surgery (ex. Age greater than 75 y/o, poor cardiopulmonary function, abnormal coagulation, end-stage renal disease, hepatic failure etc.)
2. Severe chest trauma, with large area of lung contusion or pulmonary embolism
3. More than 2 organs of systemic severe trauma (ex. combining head trauma, abdominal internal bleeding, abdominal organ rupture etc.)
4. Poor rib fracture site (ex. posterior axillary line, 1st-3rd rib, sub-scapula etc.)
5. Patient refuses surgery
6. current acute infection
7. Allergy to surgical instruments
8. Lack of sufficient blood supply, poor bone density or potential infection
9. Psychiatric or neuropathic conditions causing inability to obey doctor's order
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03487458
Study Brief:
Protocol Section:
NCT03487458