Surgical Stabilization of Rib Fractures in Denver failure ... Surgical Stabilization of Rib...

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Surgical Stabilization of Rib Fractures in Denver A Prospective Clinical Trial

Transcript of Surgical Stabilization of Rib Fractures in Denver failure ... Surgical Stabilization of Rib...

Surgical Stabilization of Rib Fractures in Denver

A Prospective Clinical Trial

Disclosures

• This work was supported by an investigator-initiated research grant from DePuy Synthes

• Paid faculty & consultant: – DePuy Synthes – Zimmer BioMet

Study Design

• Contributions – Prospective – Contemporary fixation system – Detailed fracture pattern information – Non flail chest fracture patterns – American

• Weaknesses

– Single center – Not truly randomized – Limited to acute period

• Surgical stabilization of severe rib fractures, as compared to best medical management, improves acute outcomes

Hypothesis

• Single institution, prospective, controlled evaluation

• Inclusion:

– Age ≥ 18 years – Severe rib fractures

1. Flail chest 2. ≥ 3 severely displaced fractures 3. ≥ 30% volume loss hemithorax 4. Failure of medical management

– Presentation within 72 hours of injury

Study Design

Denver Health Medical Center Algorithm for Non Operative Management of Rib Fractures

(Access response hourly)

Inadequate response defined as ≥ 1 of the following: Numeric pain score > 4 Spirometry < 75% predicted RR > 20 Poor cough/splinting/inability to clear secretions

Begin • Oral narcotics • Oral muscle relaxants • Oral/IV NSAIDs • “Rib blocks”

• Incentive spirometry • Upright position/ambulation • Cough and deep breathing

ANALGESIA

PULMONARY TOILET

Add • IV narcotics (PCA) • Continuous

intercostal nerve blockade

• Naso-tracheal suctioning

Add • Continuous thoracic

epidural catheter

• Cricothyroidotostomy tube (“mini-trach”)

• +/- Intubation/ mech ventilation

Routine therapies following intubation: Humidified O2 Positional changes E.T.T. suctioning CPAP

Inadequate response

Inadequate response

• 2013: Non-operative

• 2014: Operative

Study Design

RibScore Parameter Points

≥ 6 fractures 1

Flail chest 1

Bilateral fractures 1

≥ 3 severely displaced fractures 1

≥ 1 anterior, lateral, and posterior fracture 1

First rib fracture 1

Total 6

Results Study Flow

2013 (non-operative)

35 patients met criteria

35 analyzed

37 patients met criteria

2014 (operative)

35 analyzed

2 excluded (declined operation)

Baseline Demographics Variable Non-operative

(n=35) Operative

(n=35) p

Age (years) 50.3 + 15.1 51.0 + 15.3 0.85

Male 24 (68.6) 30 (85.7) 0.09

Mechanism 0.82

MVC/MCC 14 (40.0) 14 (40.0)

Auto/ped & bike 11 (31.4) 13 (37.1)

Fall 10 (28.6) 8 (22.9)

BMI (kg/m2) 27.5 + 5.9 27.8 + 5.7 0.87

Asthma/COPD 4 (11.4) 2 (5.7) 0.67

Tobacco use 11 (31.4) 13 (37.1) 0.61

Variable Non-operative (n=35)

Operative (n=35)

p

ISS 22.0 (17.0, 38.0) 21.5 (17.0, 26.0) 0.69

Intracranial hemorrhage 10 (28.6) 2 (5.7) 0.01

Admission GCS 14.0 (7.0, 15.0) 15.0 (14.0, 15.0) 0.03

Facial fracture 7 (20.0) 3 (8.6) 0.17

Pelvic fracture 12 (34.3) 8 (22.9) 0.19

Long bone fracture 0 1 (2.9) NA

Solid organ injury 11 (31.4) 9 (25.6) 0.60

BCVI 2 (5.7) 0 0.49

Associated Non-thoracic Injuries

Associated Non-thoracic Injuries

Variable Non-operative (n=35)

Operative (n=35)

p

ISS 22.0 (17.0, 38.0) 21.5 (17.0, 26.0) 0.69

Intracranial hemorrhage 10 (28.6) 2 (5.7) 0.01

Admission GCS 14.0 (7.0, 15.0) 15.0 (14.0, 15.0) 0.03

Facial fracture 7 (20.0) 3 (8.6) 0.17

Pelvic fracture 12 (34.3) 8 (22.9) 0.19

Long bone fracture 0 1 (2.9) NA

Solid organ injury 11 (31.4) 9 (25.6) 0.60

BCVI 2 (5.7) 0 0.49

Associated Thoracic Injuries

Variable Non-operative (n=35)

Operative (n=35) p

BPC18 3.5 (2.0, 4.0) 4.0 (2.0, 5.0) 0.67

Pneumothorax 31 (88.6) 28 (80.0) 0.51

Hemothorax 10 (28.6) 18 (51.4) 0.09

Clavicle Fracture 5 (45.5) 6 (17.1) 0.74

Scapula fracture 5 (14.3) 8 (22.9) 0.36

Spine fracture 17 (48.6) 11 (31.4) 0.09

Rib Fracture Pattern

Variable Non-operative (n=35)

Operative (n=35) p

Number of ribs fractured 8 (6, 11) 9 (7, 11) 0.18

Total number of fractures 9 (6, 13) 13 (11, 17) 0.01

> 3 severely displaced fractures 30 (85.7) 30 (85.7) 0.93

Bilateral fractures 13 (37.1) 13 (37.1) 1.00

Flail chest 11 (31.4) 28 (80.0) < 0.01

First rib fracture 9 (25.7) 16 (45.7) 0.08

Rib Score 3.0 (2.0, 4.0) 4.0 (3.0, 5.0) <0.01

Rib Fracture Pattern

Variable Non-operative (n=35)

Operative (n=35) p

Number of ribs fractured 8 (6, 11) 9 (7, 11) 0.18

Total number of fractures 9 (6, 13) 13 (11, 17) 0.01

> 3 severely displaced fractures 30 (85.7) 30 (85.7) 0.93

Bilateral fractures 13 (37.1) 13 (37.1) 1.00

Flail chest 11 (31.4) 28 (80.0) < 0.01

First rib fracture 9 (25.7) 16 (45.7) 0.08

Rib Score 3.0 (2.0, 4.0) 4.0 (3.0, 5.0) <0.01

Unadjusted Outcomes

Variable Non-operative (n=35)

Operative (n=35) p

Respiratory Failure 25 (71.4) 17 (48.6) 0.04

Tracheostomy 16 (45.7) 5 (14.3) 0.01

Pneumonia 11 (31.4) 7 (20.0) 0.28

Days mechanical ventilation 5 (0,18) 0 (0,8) <0.01

Hospital length of stay (days) 16.0 (10.0, 23.0) 13.0 (9.0, 21.0) 0.11

ICU length of stay (days) 9.0 (4.0, 15.0) 6.0 (3.0, 10.0) 0.15

Multivariable Logistic Regression

Variable Adjusted OR¥ 95% CI p

Mechanical ventilation 0.24 0.06-0.93 0.03

Tracheostomy 0.18 0.04-0.78 0.03

Pneumonia 0.53 0.14-2.00 0.62

¥Adjusted for RibScore, ISS and ICH

Spirometry

0

500

1000

1500

2000

2500

3000

1 2 3 4 5 6 7 8 9 10 11

Med

ian

spiro

met

ry

Hospital day

non-operative

operative

Median spirometry per day = 1250 (983, 1500) vs. 1000 (783, 1083), p=0.04

Narcotic Requirements

0

2

4

6

8

10

12

14

16

1 2 3 4 5 6 7 8 9 10 11 12 13 14

Med

ian

Req

uire

men

ts

Hospital Days

non-operative

operative

Median narcotic requirement per day = 9 (3,17) vs. 12 (7,25), p=0.15

• Surgical stabilization independently improved pulmonary outcomes: – Respiratory failure – Tracheostomy – Duration of mechanical ventilation – Spirometry

• Recommendation: Consideration of surgical

stabilization in all trauma patients who meet ≥ 1 inclusion criteria

Conclusion

• Do we need another RCT showing efficacy?

• Which RCTs do we need?

• How best to develop an international RCT group (e.g., ARDSnet)

Critical Next Steps

Surgical Stabilization of Rib Fractures in Denver

A Prospective Clinical Trial

• Respiratory Failure • Pneumonia • Tracheostomy

• Ventilator Days • ICU LOS • Hospital LOS

• Spirometry • Narcotic Requirements

Methods Outcomes

Results Operative Details

Variable Outcome

Ribs fractured: ribs plated 2.0 (1.0, 2.0)

Ribs plated 5 (4, 6)

Time to surgery from injury (days) 2.4 + 0.78

Surgery length (hours) 1.5 + 1.2

Number of surgeons 4

Hardware failure 1 (2.9)

Hardware infection 1 (2.9)