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:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT01367951
Eligibility Criteria:
Inclusion Criteria:
* Age \>16 or skeletal maturity
* Meeting one of the two indication for surgical fixation of chest wall injury:
1. Flail chest, defined as follows:
* 3 unilateral segmental rib fractures; OR
* 3 bilateral rib fractures; OR
* 3 unilateral fractures combined with sternum fracture/dissociation Note: at least 3 of the rib fractures involved in the flail segment must demonstrate displacement.
2. Severe deformity of the chest wall (Diagnosed by CT scan). Defined as follows:
* Severe (100%) displacement of 3 or more ribs OR
* Marked loss thoracic volume/caved in chest (\>25% volume loss in involved lobe(s)); OR
* Overriding of 3 or more rib fractures (by minimum 15mm each); OR
* Two or more rib fractures associated with intra-parenchymal injury - ie ribs in the lung, in the parenchyma
Exclusion Criteria:
* Anatomic location of rib fractures are not amenable to surgical fixation (eg fractures directly adjacent to spinal column)
* Rib fractures primarily involving floating ribs (ribs 10-12)
* Home Oxygen (O2) requirement
* Other significant injuries that may require long term intubation:
* Severe pulmonary contusion (Defined as PaO2/FIO2 ratio \<200 with radiological evidence of pulmonary infiltrates WITHIN 24 hours of THORACIC TRAUMA)
* Severe head injury/Traumatic brain injury - (GCS ≤ 8 at 48 hrs post injury. If unable to assess full GCS due to intubation or other causes, GCS motor ≤4 at 48 hrs post injury)
* Upper airway injury requiring long term intubation and mechanical ventilation (e.g. tracheal disruption)
* Acute quadriplegia/quadraparesis
* Head and neck burn injuries, or inhalation burn injuries
* Dementia or other inability to complete follow-up questionnaires
* Medically unstable for OR (e.g. haemodynamic instability, acidosis, coagulopathy, etc.)\* or unlikely to survive 1 year follow-up, in the opinion of the attending physician
* Lack of informed consent from patient or substitute decision maker
* Randomization \> 72 hours from injury
* ORIF \> 96 hours from injury (if randomized to surgical fixation group)
* Age \> 85
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
85 Years
Study:
NCT01367951
Study Brief:
Protocol Section:
NCT01367951