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.

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).

Rib Fracture

Rib Fracture Multiple

Trauma

Trauma Chest

Trauma Injury

Trauma, Multiple

RibFx Orthosis Belt

University of Vermont Medical Center

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

Orthosis of Acute Traumatic Rib Fractures Via RibFx Belt for Pain Alleviation and Improved Pulmonary Function: A Pre-Post Interventional Trial for Quality Improvement

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.

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.

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).

As measured in inpatient days for all subjects admitted with rib fracture

As measured in inpatient Intensive Care Unit (ICU) days for all subjects admitted with rib fracture

As measured by clinical diagnosis of pneumonia following rib fracture, either documented in physician note or added to problem list

As measured by a participating blinded radiologist in any images obtained following the rib fractures

As measured by requirement for additional / supplemental oxygen , as determined by clinical treatment team

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.

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.

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)

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)

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.

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).

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).

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).

Ajai Malhotra, MD FACS

Chief, Acute Care Surgery Division

PelvicBinder, Inc.

8 mg dexamethasone, single preoperative infusion

Complication, Postoperative

10 mg/kg methylprednisolone mixed in 100 ml NaCl (sodium chloride), infusion over 30 minutes, prior to surgery

Methylprednisolone

Dexamethasone mixed in 100 ml NaCl, infusion over 30 minutes, prior to surgery

Dexamethasone

Rigshospitalet

Preoperative High Dose Steroids for Liver Resection- Effect on Complications in the Immediate Postoperative Period

High Dose Steroids for Liver Resection - Effect on Complications and Endothelial Function in the Immediate Postoperative Phase - a Randomized, Doubleblind, Controlled Trial

Number of patients with any complication at any time, during stay in the PACU. Complications according to DASAIMS discharge criteria (modified Aldrete criteria)

Amount of endothelial markers (Syndecan-1, soluble thrombomodulin, SE-Selectin, vascular endothelial growth factor (VEGF) )

Number of patients with post-operative cognitive impairment, according to 3-minute diagnostic confusion assessment method (3D-CAM)

every 60 minutes, during stay in PACU. Numeric Rating Scale (NRS 0-10)

During admission, self reported. Numeric Rating Scale (NRS 0-10)

During admission, self reported. (Light, none, moderate, heavy nausea)

All analgesics other than standard medication, during admission. From Medical record.

All antiemetics other than standard medication, during admission. From Medical record.

impact on ALAT (alanin-aminotransferase) post surgery

impact on INR (International Normalized Ratio) post surgery

Kristin Julia Steinthorsdottir

Principal Investigator

Rigshospitalet, Denmark

The intervention group will be called EGHEM - Echo Guided HEmodyanmic Management - and will receive their intraoperative maintenance fluid and possible drug therapy (furosemide) based on their hourly intraoperative LVDD grade.

The control group will be
called SHEM - Standard HEmodynamic Management - and will NOT receive the study intervention, but will receive standard anesthesia and hemodynamic management based on current standards within the institution.

pleural effusion/nikotin

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

Preoperative High Dose Steroids for Liver Resection- Effect on Complications in the Immediate Postoperative Period

Echocardiography Management for Patients Requiring Care for Non-Cardiac Surgery

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