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Orthosis of Acute Traumatic Rib Fractures Via RibFx Belt for Pain Alleviation and Improved Pulmonary Function (RibFx)

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ClinicalTrials.gov Identifier: NCT03846024
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
PelvicBinder, Inc.
Information provided by (Responsible Party):
Ajai Malhotra, MD FACS, University of Vermont Medical Center

Brief 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 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.


Condition or disease Intervention/treatment Phase
Rib Fracture Rib Fracture Multiple Trauma Trauma Chest Trauma Injury Trauma, Multiple Device: RibFx Orthosis Belt Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RibFx belt arm
Each patient in the interventional arm will be fitted with a RibFx orthosis belt, which is to be worn during the majority of their day (excluding showering/bathing). It will be encouraged (though not mandatory) to wear at night. Patients in both the control and interventional arm will be expected to participate in pulmonary hygiene / toilet exercises with guided and independent incentive spirometry as per our normal routine and standard of care. There are no other interventions or procedures that the patients will be subjected to for the research trial- other procedures/interventions will be performed only if the clinical care team feels they are indicated.
Device: RibFx Orthosis Belt
Each patient in the interventional arm will be fitted with a RibFx orthosis belt, which is to be worn during the majority of their day (excluding showering/bathing). It will be encouraged (though not mandatory) to wear at night. Patients in both the control and interventional arm will be expected to participate in pulmonary hygiene / toilet exercises with guided and independent incentive spirometry as per our normal routine and standard of care. There are no other interventions or procedures that the patients will be subjected to for the research trial- other procedures/interventions will be performed only if the clinical care team feels they are indicated.

No Intervention: Control

Patients in the control arm receive normal standard of care for rib fractures at the participating institution.

The current standard of care for rib fractures at the University of Vermont (participating institution) is as follows: includes oral and IV analgesia and other multimodal pain control as appropriate, including muscle relaxants such as methocarbamol (robaxin) unless there is a contraindication, pulmonary hygiene/toilet and respiratory care (including frequent evaluations by physicians, respiratory therapists, and nursing staff, early mobilization, and monitoring for pulmonary complication (via vital signs, pulse oximetry, oxygen requirement, chest imaging if appropriate).




Primary Outcome Measures :
  1. Rib Fracture Subjective Self-Reported Pain [ Time Frame: 4 weeks ]
    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.

  2. Narcotic/ Opioid Pain medication requirement after rib fracture [ Time Frame: 4 weeks ]
    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.


Secondary Outcome Measures :
  1. Incentive Spirometery Score [ Time Frame: 4 weeks ]

    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).


  2. Hospital Length of Stay [ Time Frame: 4 weeks (only measured while inpatient) ]
    As measured in inpatient days for all subjects admitted with rib fracture

  3. ICU Length of Stay [ Time Frame: 4 weeks (only measured while inpatient) ]
    As measured in inpatient Intensive Care Unit (ICU) days for all subjects admitted with rib fracture

  4. Pneumonia Post Rib Fracture [ Time Frame: 4 weeks ]
    As measured by clinical diagnosis of pneumonia following rib fracture, either documented in physician note or added to problem list

  5. Atelectasis Post Rib Fracture [ Time Frame: 4 weeks ]
    As measured by a participating blinded radiologist in any images obtained following the rib fractures

  6. Supplemental oxygen requirement following rib fractures [ Time Frame: 4 weeks ]
    As measured by requirement for additional / supplemental oxygen , as determined by clinical treatment team

  7. Pulse oximetry scores of subjects [ Time Frame: 4 weeks (only measured while inpatient) ]

    The pulse oximetry scores of rib fracture subjects will be measured while inpatient as a non-invasive proxy measurement of tissue oxygenation.

    These data are regularly recorded during vital signs for all patients admitted to Trauma Surgery service.


  8. Respiratory rate of subjects [ Time Frame: 4 weeks (only measured while inpatient) ]
    The respiratory rate of rib fracture subjects will be measured while they are inpatient in the hospital, as a measure of pulmonary health and pain control. These data are regularly recorded during vital signs for all patients admitted to Trauma Surgery service.

  9. Compliance with Incentive Spirometer [ Time Frame: 24 hours after admission and enrollment, and at 2-4 weeks post injury ]
    Subject compliance with encouraged use of the incentive spirometer device for pulmonary hygiene following acute rib fractures will be measured by patient self reported frequency on the patient questionnaire, in both frequency (total number of uses) and duration of usage (hours and minutes of usage)

  10. Compliance with RibFx belt (if applicable) [ Time Frame: 24 hours after admission and enrollment, and at 2-4 weeks post injury ]
    Subject compliance with encouraged use of the RibFx device (if assigned to the intervention group) following acute rib fractures will be measured by patient self reported frequency on the patient questionnaire, in both frequency (total number of uses) and duration of usage (hours and minutes of usage)

  11. Patient reported respiratory health as determined by COPD Assessment Test (CAT) [ Time Frame: 24 hours after admission and enrollment, and at 2-4 weeks post injury ]
    This previously validated survey contains 8 questions , each with a likert scale response of 0 (best or most favorable score) to 5 (worse or least favorable score). The total score is then cumulated to serve as a proxy of patient's own self reported respiratory (breathing) health.

  12. Patient self reported quality of life , as determined by questionnaire qualitiative assessment [ Time Frame: 24 hours after admission and enrollment, and at 2-4 weeks post injury ]
    There is a series of three questions meant to assess how the rib fractures are affecting patient's sleep, activity, and quality of life as determined by a likert scale from 0 (most favorable, does not interfere with life) to 10 (most unfavorable, totally interferes with life).

  13. Patient reported over-the-counter pain medication usage following rib fracture [ Time Frame: 24 hours after admission and enrollment, and at 2-4 weeks post injury ]
    Patients will report how frequently they are using over the counter pain medications such as acetaminophen and ibuprofen for acute rib fracture pain. This will be reported by the patients on the questionnaires as a binary yes/no response followed by frequency (total number of times taking the medications).

  14. Patient reported prescribed pain medication usage following rib fracture [ Time Frame: 24 hours after admission and enrollment, and at 2-4 weeks post injury ]
    Patients will report how frequently they are using prescribed pain medications for acute rib fracture pain. This will be reported by the patients on the questionnaires as a binary yes/no response followed by frequency (total number of times taking the medications).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846024


Contacts
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Contact: Ethan D Jones, MPH 802-656-9437 ethan.d.jones@med.uvm.edu
Contact: Jennifer Gratton, RN 802-847-5206 Jennifer.Gratton@uvmhealth.org

Locations
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United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Ethan D Jones, MPH    802-656-9437    ethan.d.jones@med.uvm.edu   
Contact: Jennifer Gratton, RN    802-847-5206    Jennifer.Gratton@uvmhealth.org   
Sponsors and Collaborators
University of Vermont Medical Center
PelvicBinder, Inc.
Additional Information:
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Responsible Party: Ajai Malhotra, MD FACS, Chief, Acute Care Surgery Division, University of Vermont Medical Center
ClinicalTrials.gov Identifier: NCT03846024    
Other Study ID Numbers: IRB CHRMS 18-0646
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Ajai Malhotra, MD FACS, University of Vermont Medical Center:
RibFx
PelvicBinder
Rib Fractures
Trauma
Pulmonary toilet
Incentive Spirometry
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries
Rib Fractures
Fractures, Multiple
Multiple Trauma
Thoracic Injuries