Liposomal Bupivacaine (1.3%) solution (20 mL dose). This solution has demonstrated increased efficacy in prolonged analgesia following injection. This solution will be injected as an ultrasound-guided subpectoral interfacial plane block.

Normal saline (0.9%) will be used as the control solution for patients not receiving the liposomal bupivacaine solution. Injection procedure of this solution will be identical to that of the liposomal bupivacaine solution.

Cardiovascular Surgery

Pain, Postoperative

Block

Sternal Block during Coronary Artery Bypass Graft Surgery and/or surgical aortic valve replacement through mini- or full sternotomy

Liposomal bupivacaine

Normal Saline Flush, 0.9% Injectable Solution_#1

Baylor Scott & White Heart Hospital - Plano

Sternal Block With Liposomal Bupivacaine vs. Saline Prior to Incision in Cardiac Surgery

Regional Blockade of the Sternum With Liposomal Bupivacaine Prior to Incision Decreases Opioid Use in Patients Undergoing Cardiac Surgery (Sternal Block)

The amount of opioid medications used will be recorded during the routine postoperative course.

At this point, we do not plan to shared IPD but will share cumulative results in an abstract and manuscript.

Baylor Research Institute

The surgeon, coordinator and anesthesiologist on the case are blinded to the block drug. A 2nd (unblinded) anesthesiologist performs the block on the patient.

Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe harvest subdermal fat

Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction (AD-cSVF)

COPD

Respiratory Insufficiency

Close syringe microcannula harvesting subdermal fat and perivascular stem/stromal cells

Lipoaspiration

AD-cSVF

Normal Saline IV

Global Alliance for Regenerative Medicine-USA

Global Alliance of Regenerative Medicine (GARM) International

Use of Autologous Stem/Stromal Cells In Chronic Lung Disorders: Obstructive (COPD) & Restrictive (RLD)

Use of Autologous Stem/Stromal Cells in Chronic Lung Disorders: Obstructive (COPD) and Restrictive (RLD)

Pulmonary Function as occurrence or frequency of adverse or severe adverse events during study

Healeon Medical Inc

Robert W. Alexander, MD

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.

Patients with diagnosis of LCH based on histopathological or clinical and radiological findings.

Current or ex smokers matched with cases for age, gender and smoking history.

Langerhans Cell Histiocytosis

InCor Heart Institute

Evaluation of Exercise Capacity and Exercise Limitation in Patients With Pulmonary Langerhans Cell Histiocytosis

Evaluation of Exercise Capacity and Mechanisms of Exercise Limitation in Patients With Pulmonary Langerhans Cell Histiocytosis

Maximal O2 uptake capacity (VO2 max) during a cardiopulmonary exercise test (mL/kg/min)

Distance during a six-minute walk test in meters

SF-36 questionnaire to evaluate quality of life

Diffusing capacity for carbon monoxide (mL/min/mmHg)

Serial measurement of inspiratory capacity during incremental cardiopulmonary exercise test (L)

FEV1 (Pulmonary lung function - spirometry) - L

Velocity measurement of tricuspid regurgitant jet evaluated by transthoracic echocardiography (m/s)

Residual volume/total lung capacity ratio evaluated in pulmonary lung function - plethysmography

Residual volume evaluated in pulmonary lung function - plethysmography (L)

Desaturation during a six-minute walk test (%)

Ejection fraction evaluated by transthoracic echocardiography (%)

Diameter of the cardiac chambers evaluated by transthoracic echocardiography (cm)

pneumothorax/− nikotyna

Sternal Block With Liposomal Bupivacaine vs. Saline Prior to Incision in Cardiac Surgery

Use of Autologous Stem/Stromal Cells In Chronic Lung Disorders: Obstructive (COPD) & Restrictive (RLD)

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

Evaluation of Exercise Capacity and Exercise Limitation in Patients With Pulmonary Langerhans Cell Histiocytosis

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