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 @ 1:19 PM
Ignite Modification Date:
2025-12-24 @ 1:19 PM
NCT ID:
NCT03221595
Eligibility Criteria:
Inclusion Criteria:
1. Hospitalization with ≥ 3 severely displaced (≥ 50% of rib width) acute rib fractures.
2. Two or more of the following pulmonary physiologic derangements (at the time of consideration for enrollment and after best medical therapy).
1. Respiratory rate \> 20 breaths per minute
2. Incentive spirometry \< 50% predicted (appendix D)
3. Numeric pain score \> 5
4. Poor cough (as documented by respiratory therapist)
3. Surgery anticipated \< 72 hours from injury
Exclusion Criteria:
1. Age \< 18 years or ≥ 80 years
2. Flail chest: either radiographic or clinical. Radiographic flail chest is defined on CT chest as ≥ 2 ribs each fractured in ≥ 2 places. Clinical flail is defined as visualization of a segment of chest wall with paradoxical motion on physical exam.
3. Moderate or severe traumatic brain injury (GCS at the time of consideration for enrollment \< 12)
4. Intubation
5. Severe pulmonary contusion, defined as Blunt Pulmonary Contusion 18 (BPC18) score \> 12 \[19\].
6. Prior or expected emergency exploratory laparotomy during this admission.
7. Prior or expected emergency thoracotomy during this admission.
8. Prior or expected emergency craniotomy during this admission.
9. Spinal cord injury
10. Pelvic fracture that has required, or is expected to require, operative intervention during this admission.
11. The patient was unable to accomplish activities of daily living independently prior to injury (e.g., dressing, bathing, prepearing meals).
12. Pregnancy.
13. Incarceration.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03221595
Study Brief:
Protocol Section:
NCT03221595