Trauma Clinical Trial
— RibFxOfficial title:
Orthosis of Acute Traumatic Rib Fractures Via RibFx Belt for Pain Alleviation and Improved Pulmonary Function: A Pre-Post Interventional Trial for Quality Improvement
Verified date | December 2022 |
Source | University of Vermont Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 enrollment in the study and will be assigned by the study team into either the intervention (RibFx belt +current standard of care) or control (current standard of care) arm in a quasi-experimental prospective design: untreated control group with dependent pretest and posttest samples. In this manner, the intervention arm will be both compared to themselves (pretest vs. posttests) as well as to a control group not exposed to the intervention. The relevant study materials will be included in their paper (physical) and electronic chart. Patients upon enrollment in the study will undergo an initial assessment that will include their baseline pain scores, narcotic consumption, incentive spirometry scores, and the subjective self-reported results of their questionnaire (the pre-test questionnaire- see attached). Patients will continue to be scored on objective (incentive spirometry results, opioid pain medicine consumption) and subjective variables (pain scores) during their hospital course. Between 24-48 hours after enrollment, they will be prompted to again complete a similar 2nd questionnaire post-test (if they are discharged from the hospital at this point in the time course, they will be sent home with the questionnaire and prompted to complete it at home). At their follow up appointment in trauma clinic (which will be coordinated by the research team to be as close as possible to 3 weeks post injury), they will have the opportunity to again voluntarily complete a final short questionnaires (post-test) that assess their pain control and respiratory function over the last 3 weeks. At this point, their involvement in the trial will be complete. Patients themselves will play an active role in data collection during the trial, and will be instructed and prompted in how to do so. Patients will be expected to fill out a worksheet on a daily basis, both while inpatient and after discharge, on their daily incentive spirometry scores as well as their minimum and maximum pain scale scores. This will be used to supplement the survey or questionnaire data, as well as the objective data from the electronic medical record. The investigators will ultimately compare groups using a quasi-experimental design as follows: Untreated control group with dependent pretest and posttest samples. This will allow for a direct comparison of patient to patient within the intervention arm (patient pretest result serving as control compared to posttest result) . To observe for temporal variability, their will be a control group with no intervention as well (no rib belt worn) , however the principle aim of the study is the comparison of patients to themselves in a pre-test, post-test fashion.
Status | Terminated |
Enrollment | 27 |
Est. completion date | April 9, 2020 |
Est. primary completion date | April 9, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Adult person age 18-80 admitted with at least one acute traumatic closed rib fracture to the University of Vermont Medical Center Exclusion Criteria: - Pediatric (<18 year old) and Geriatric (>80 year old) patients - Patients who are intubated on arrival or within first 24 hours of admission or with Glasgow Coma Scale (GCS) < 14 (altered or depressed consciousness) - Pregnant patients - Patients who undergo operative rib fixation for their rib fractures (such as open reduction internal fixation, or rib plating) - Patients with chest wall deformity, lacerations, burns, or soft tissue injuries that preclude placement of the RibFx belt - Patients with an additional mechanism of injury that would create severe distracting pain, as determine by the admitting team. - Isolated 1st rib or 2nd rib fractures |
Country | Name | City | State |
---|---|---|---|
United States | University of Vermont Medical Center | Burlington | Vermont |
Lead Sponsor | Collaborator |
---|---|
University of Vermont Medical Center | PelvicBinder, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rib Fracture Subjective Self-Reported Pain (Inpatient) | Compare pain control in patients with non-operatively managed traumatic rib fractures via subjective/qualitative self-reporting of pain control via questionnaires Pain control will be predominantly measured utilizing a likert scale score of 1 to 10, with a score of 1 denoting the lowest amount of pain and a score of 10 indicating the highest amount of pain. This will assist us in comparing patient pain scores in an objective manner. | Inpatient Stay | |
Primary | Narcotic/ Opioid Pain Medication Requirement After Rib Fracture (Inpatient) | Count of participants who required any use of a prescribed pain medication at any point throughout their inpatient stay. | Inpatient Stay | |
Primary | Narcotic/ Opioid Pain Medication Requirement After Rib Fracture (Home) | Count of participants who required any use of a prescribed pain medication at any point between their discharge from the hospital and their follow up appointment at 4 weeks. | 4 Week Follow Up | |
Primary | Rib Fracture Subjective Self-Reported Pain (Home) | Compare pain control in patients with non-operatively managed traumatic rib fractures via subjective/qualitative self-reporting of pain control via questionnaires Pain control will be predominantly measured utilizing a likert scale score of 1 to 10, with a score of 1 denoting the lowest amount of pain and a score of 10 indicating the highest amount of pain. This will assist us in comparing patient pain scores in an objective manner. | 4 Week Follow Up | |
Secondary | Incentive Spirometry Score (Inpatient) | Compare pulmonary hygiene and function amongst patients with non-operatively managed traumatic rib fractures via incentive spirometry scores.
Incentive spirometry will be used as a tool to measure and compare patient pulmonary hygiene. The incentive spirometer at the participating institution are scaled to permit quantifiable deep breathing from 0 to 2500 mL (or cc). |
Inpatient Stay | |
Secondary | Pneumonia Post Rib Fracture | As measured by clinical diagnosis of pneumonia following rib fracture, either documented in physician note or added to problem list | 4 Week Follow Up | |
Secondary | Atelectasis Post Rib Fracture | As measured by a participating blinded radiologist in any images obtained following the rib fractures | 4 Week Follow Up | |
Secondary | Incentive Spirometry Score (Home) | Compare pulmonary hygiene and function amongst patients with non-operatively managed traumatic rib fractures via incentive spirometry scores.
Incentive spirometry will be used as a tool to measure and compare patient pulmonary hygiene. The incentive spirometer at the participating institution are scaled to permit quantifiable deep breathing from 0 to 2500 mL (or cc). |
4 Week Follow Up |
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