A Multicenter Randomized Trial on the Early Stabilization of - - PowerPoint PPT Presentation

A Multicenter Randomized Trial on the Early Stabilization of Fracture Ribs (SOFRIB)

Darwin Ang, MD PhD MPH FACS

Ocala Regional Medical Center

Disclosure

• This project is funded by a private industry

competitive grant.

• Request for Proposal: “A Multicenter

Prospective Randomized Trial on the Intervention of Rib Fixation (within 2-5 Days) for Clinically Severe Fractures from Trauma”

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Objective

To create a multicenter randomized study investigating the differences in clinical

• utcomes between patients who receive rib

fixation and those who receive modern critical care and pain control after sustaining clinically significant rib fractures from trauma.

Stabilization of Fractured Ribs (SOFRIB) Consortium

• PI and site PIs
• Site coordinators

– Blake, Bayonet Point, Ocala, Lawnwood, Kendall, Grand Strand (South Carolina), Research (Kansas), Osceola Medical Center, – Research Coordinator, Donna Nayduch

• Study Administrators, Sarah Cannon Research Institute

(SCRI), Erika Frazier (Director, Health Economics & Outcomes Research Group)

• Biostatistician and Epidemiologist, Dr. Jonathan

Sugimoto, (University of Washington)

• Database Coordinator, Annette O’Dell (USF)
• Data Analyst and Statistical Support, Huazhi Liu (HCA)

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Study Aims

• Primary
• Aim 1: To determine if patients who have

clinically significant rib fractures will have shorter lengths of ICU stays between those who receive non-operative management and those who undergo rib fixation.

• Hypothesis: Patients who receive rib fixation will

have significantly lower ICU lengths of stay.

Secondary Study Aims

• Aim 2: To evaluate the quality of life and

individual health assessments of patients who underwent rib fixation versus those who received non-operative treatment

• Hypothesis: Patients who receive the SF-36 and

PIQ-6 surveys will report significantly better

• utcomes among those who received rib fixation

compared to those who were managed non-

• peratively.

Secondary Study Aims

• Aim 3: To compare rates of hospital acquired

complication rates (see definition) between those where received rib fixation to those who received non-operative management

• Hypothesis: Patients who had rib fixation will

have significantly lower complication rates (see definition) compared to those who were managed non-operatively

Secondary Study Aims

– Ventilator days, ventilator free days, time to wean from ventilator – Pain control documented by the Functional Pain Scale: admission, postop, and at time of discharge – Narcotic usage converted to units of morphine – Mortality rates – Hospital length of stay – Complications and their rates

• Pneumonia: 480-486 , Urinary Tract Infection: 599.0, 771.82, Arrhythmias:

427.9, 427.41, Sepsis: 995.91, 771.81, 995.92, Reintubation: 9604 (procedure code), Wound Infection: 998.51, 998.59, Cardiac arrest: 427.5, 779.85, 668.1, 668.10, 668.11, 668.12, 668.13, 668.14, Deep venous thrombus: 453.4x, 453.8, Coagulopathy: 286.6, 286.9, Pulmonary embolus: 415.1x

– Tracheostomy rates – Charges and costs – Pulmonary Function: Forced Vital Capacity (FVC), FEV1

• Measured at discharge, 3 months, and 6 months

– Return to work

• 6 month follow up

Inclusion Criteria (3 or more ribs)

• ≥3 ribs (any type) with worsening oxygenation

(↑O2 support) or worsening ventilation (↑RR >25 bpm or failure to wean from vent)

• Flail chest defined as 3 or more consecutive ribs

fractured in more than one place

• Pain and disability of a FPS (Functional Pain

Scale) rating of 3 or higher

• Any rib with Deformity and Defect (intrapleural

deformity)

• 3 or more rib fractures with rib displacement of

more than 1 rib cortical diameter

Functional Pain Scale

Rating Description 0 No pain 1 Tolerable (and does not prevent any activities) 2 Tolerable (but does prevent some activities) 3 Intolerable (but can use telephone, watch TV, or read) 4 Intolerable (but cannot use telephone, watch TV, or read) 5 Intolerable (and unable to verbally communicate because of pain) Source: Gloth FM III, Scheve AA, Stober CV, Chow S, Prosser J. The Functional Pain Scale: reliability, validity, and responsiveness in an elderly population. J Am Med Dir Assoc. 2001;2(3):110- 114.

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Exclusion Criteria

• Active bacteremia
• Active shock (distributive, cardiogenic, obstructive,
• r hypovolemic)
• Severe Traumatic Brain Injury with GCS < 8
• Age 17 years or less or age greater than 90 years old
• Chronic pulmonary disease requiring home
• xygenation
• Acute Respiratory Distress Syndrome (ARDS)
• Penetrating chest trauma (because cannot

randomize to non-operative arm)

• Chronic Opioid dependence or use
• Fractures less than 3 cm from the vertebral spine

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Randomization

12 Figure 1: CONSORT Randomized control trial flow diagram Assess for eligibility Randomize Excluded Rib Plating Non-operative

Allocation

Lost to follow up Lost to follow up

Follow up

Analyzed N Analyzed N

Analysis

Stratified by injury severity and research site

Two Study Arms

• Operative
• Indication: Patients who meet inclusion criteria and none of the

exclusion criteria for this study.

• Timing: should be performed after resuscitation and within 2-5

days of the injury

• Diagnosis: All patient injuries will be diagnosed by CT scan. A 3-

dimensional image of the bony elements of the thorax is preferred.

• Technique

– Surgical Approach: – contoured rib implants – Ribs 2-10

• Nonoperative:
• A standard clinical pathway will be used to control pain based on

evidence based measures, especially for rib fractures.

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Non-Operative Management

Randomized to nonoperative PCA Contraindication to NSAID? Start NSAID Adequate Pain Control?

No YES

Epidural or Paravertebral PO Pain Meds

YES No

IV Narcotics titrated by pain scale

ICU Admission and Discharge Criteria

• ICU ADMIT CRITERIA (all pts)

– Age > 64 WITH > 4 rib fractures (isolated rib injury) – 3 or more rib fractures requiring positive pressure ventilation to maintain Sats >90% or RR <30 – Solid organ injury – Trauma brain injury

• ICU DISCHARGE CRITERIA (pulmonary criteria)

– On or Transitioned to nasal cannula – SpO2 > 92% – RR < 30 – Stable solid organ injury or TBI

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Posterolateral Thoracotomy

DJ12702A

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Position Plate Drill Confirm Rib Thickness (optional)

Plating Technique – Open Approach*

*The above steps are only an overview of the complete surgical technique required for the MatrixRIB Fixation System. Prior to performing any surgical procedure with the MatrixRIB Fixation System, please ensure to fully review the MatrixRIB technique guide and package insert, which includes full Instructions for Use, Indications, Contraindications, Warnings, and Precautions.

DSUS/CMF/0315/0331

Power Analysis

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Power

Categorical Outcomes

Pneumonia Mortality* for flail chest only Reintubation** Complication rates 0.8 862 346 544 160 0.9 1128 446 724 206

Power Continuous Outcomes

ICU days*** Ventilator days Hospital days SF-36 0.8 236 128 380 504 0.9 316 172 508 674

Data from USF/HCA Trauma Centers

AHCA data used for this study Lawnwood (January 1, 2010) 2010 Q1 to 2013 Q1 Kendall (Nov. 19, 2011) 2012 Q1 to 2013 Q1 Blake (Nov. 19, 2011) 2012 Q1 to 2013 Q1 Bayonet (Nov. 19, 2011) 2012 Q1 to 2013 Q1 Orange Park (Nov. 19, 2011) 2012 Q1 to 2013 Q1 Ocala (Dec. 8, 2012) 2013 Q1

HCA Data

Non Rib Fractures

N=11,923

Rib Fracture (>=3)

N=921

Rib Fracture (<3)

N=611

Flail

N=26

Age 18~54 46.1% 43.3% 47.5% 46.2% 55~64 12.7% 19.5% 16.2% 23.1% 65-74 12.6% 14.3% 14.4% 19.2% 75-84 15.8% 13.9% 11.8% 7.7% >84 12.8% 8.9% 10.2% 3.9% Gender Male 56.4% 65.6% 63.8% 69.2% Female 43.6% 34.4% 36.2% 30.8% Injury Mechanism Blunt 95.2% 99.2% 97.7% 100% Penetrating 2.8% 0.3% 1.8% 0% Burn 2.1% 0.4% 0.5% 0% Tracheostomy Yes 1.8% 7.4% 4.1% 34.6% No 98.2% 92.6% 95.9% 65.4% ICISS <0.5 2.3% 9.8% 5.2% 46.2% 0.5~0.6 0.8% 5.1% 3.0% 19.2% 0.6~0.7 1.5% 13.1% 7.4% 15.4% 0.7~0.8 4.4% 26.8% 15.6% 11.5% 0.8~0.9 19.4% 29.6% 34.9% 7.7% >0.9 71.6% 15.5% 34.0% 0%

Rib fracture outcomes in the USF/HCA Trauma Network

Mortality OR OR* Rib Fracture (>=3) 3.8% 2.29 (1.74, 3.01) 2.31 (1.75, 3.06) Rib Fracture (<3) 3.9% 1.27 (0.84, 1.94) 1.27 (0.83, 1.94) Flail Chest 11.5% 4.06 (1.22, 13.59) 4.34 (1.28, 14.65) Non Rib Fracture 3.1% LOS Total Charges Rib Fracture (>=3) 9.5 (±12.8) 187,906 (±227,654) Rib Fracture (<3) 7.0 (±8.9) 145,423 (±174,896) Flail Chest 22.8 (±29.5) 476,543 (±561,522) Non Rib Fracture 5.5 (±8.8) 104,643 (±147,098)

* Adjusted by age, gender, race, injury mechanism, ICISS

Prevalence of Complications

Complication HCA Trauma Centers No Rib Fractures Rib Fracture (>=3) Rib Fracture (<3) Flail Pneumonia 3.9% 10.3% 7.0% 19.2% Urinary tract infection 8.1% 7.5% 7.2% 19.2% Arrhythmias 0.5% 0.8% 0.5% 0% Sepsis 2.4% 3.4% 2.0% 7.7% Reintubation 6.2% 16.1% 12.3% 38.5% Wound infection 0.5% 0.7% 0.8% 7.7% Cardiac arrest 0.9% 3.5% 2.3% 3.9% Deep venous thrombus 0.7% 0.8% 0.5% 3.9% Coagulopathy 0.5% 0.3% 1.2% 3.9% Pulmonary embolus 0.6% 0.8% 1.0% 3.9% >=3 of the 10 complications 0.4% 1.0% 0.8% 0% Overall Pts with at least 1 Complication 18.0% 27.1% 23.7% 61.5%

Timeline

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Months -3 to Months 0 to 6 Months 6 to 12 Months 13 to 24 Months 25 to 36 Months 27 to 42 IRB approval Manual of operations Personnel training Subject enrollment** Subject follow-up Data management Data analysis Manuscript preparation Future study design

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SOFRIB Trauma Centers

SOFRIB Site PI and Coordinator’s logistic and scientific meeting

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Rib Plating Course for SOFRIB Investigators: Standardizing Surgical Techniques

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Investigators PI, EMR, Pharmacy meeting

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Same electronic order set across the study group for all patients with rib fractures

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Titrate Narcotics to level of pain

Ongoing Logistics and Progress

• Biweekly

– study coordinator calls for study logistics – site PI calls for recruitment – calls with SCRI and Synthes keep track of milestones

• Enrolled 31 patients from 4/7(1) sites thus far

from a 5 month period of active recruitment.

• At 50% recruitment for the study will perform

interval analysis by DSMB.

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Acknowledgements

• DePuy Synthes CMF and Johnson & Johnson
• SOFRIB consortium of researchers and coordinators
• Sara Cannon Research Institute
• Donna Nayduch, RN MSN
• James Hurst, MD
• Michele Ziglar, RN MSN
• Ravi Chari, MD
• Huazhi Liu, MS
• Jacob Drewry, local Synthes rep
• Ocala Trauma (Drs. Garcia, Farrah, Hagan, and Clark)
• Ocala Regional Medical Center (Randy McVay, CEO)

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