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NCT03846024 · ClinicalTrials.gov registry record · NA
Orthosis of Acute Traumatic Rib Fractures Via RibFx Belt for Pain Alleviation and Improved Pulmonary Function
A NA study, sponsored by University of Vermont Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 27
- Enrollment target
NCT03846024 is a NA study that was terminated before completion, run by University of Vermont Medical Center. The registered enrollment target is 27 participants.
The verdict
NCT03846024, a NA study, was terminated before completion, sponsored by University of Vermont Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 27 participants
- Enrollment target
Study Summary
Acute traumatic rib fractures are a common issue for patients of trauma surgeons. They inflict substantial morbidity, the most dreaded and consequential of which are pulmonary complications. While these fractures are often treated non-operatively, there is a continued need for effective adjuvant treatments to improve rib fracture pain and outcomes. Prior studies have evaluated outcome measures for traumatic rib fractures that include respiratory failure, tracheostomy requirement, ICU length of stay, hospital length of stay, narcotic requirement, daily maximum incentive spirometry volume, pneumonia, and mortality . Rib belts, which have been present since at least 1945, have long been used to provide pain relief via chest wall stabilization \[3\]. However there is an extreme paucity of literature regarding their clinical efficacy, and their use has largely been abandoned due to concerns that they may have been overly constricting and resulted in poorer respiratory (pulmonary/breathing) outcomes. Newer generation rib belts are more elastic and theoretically less constricting than their earlier generation predecessors, however their clinical efficacy has not been yet demonstrated. The investigators will therefore plan to perform a prospective trial to determine if these rib strapping devices are effective clinical tools in the traumatic rib fracture population. The goal of the study is institutional quality improvement, to determine if the investigators see benefit of these devices for the pain management of our trauma population. The investigators will also conduct this as a pilot trial for hopeful future research applications, however the overall goal is institutional improvement. Patients determined to be eligible for the study by the admitting physician (and per the previously defined criteria) will be recruited to enroll in the project within the first 24 hours of their hospital admission. Recruited patients will be offered the opportunity to consent to enrollme
Interventions
- DEVICE RibFx Orthosis Belt
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2018-07-25 |
| Est. Completion | 2020-04-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03846024
The ClinicalTrials.gov registry entry for NCT03846024 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Vermont Medical Center, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RibFx Orthosis Belt is the first listed.
NCT03846024 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03846024 about?
NCT03846024 is a clinical study titled "Orthosis of Acute Traumatic Rib Fractures Via RibFx Belt for Pain Alleviation and Improved Pulmonary Function". Acute traumatic rib fractures are a common issue for patients of trauma surgeons. They inflict substantial morbidity, the most dreaded and consequential of which are pulmonary complications. While these fractures are often treated non-operatively, there is a continued need for effective adjuvant tre...
What is the current status of trial NCT03846024?
This trial is currently terminated. It is a NA study. The enrollment target is 27 participants. The study started on 2018-07-25. Estimated completion is 2020-04-09.
What interventions are being tested in trial NCT03846024?
The interventions under investigation include: RibFx Orthosis Belt (DEVICE).
Who is sponsoring clinical trial NCT03846024?
This trial is sponsored by University of Vermont Medical Center, which has 27 total clinical trials registered on ClinicalTrials.gov.
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