itclamp™50 clinical training...10 king, d., et al. forward assessment of 79 prehospital...
TRANSCRIPT
iTClamp™50 Clinical Training
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• Explain the impact of bleeding in trauma
• Recognize the importance of rapid haemorrhage control
• Classify wounds on the spectrum of bleeding
• Select appropriate intervention for type of bleeding
• Understand how iTClamp fits into an overall haemor-
rhage control strategy
Objectives
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• Bleeding is the leading cause of preventable death in all types of traumatic injuries1
• Current research indicates stopping haemorrhage early is critical to good outcomes1,2
• 25% of trauma patients arriving in the ED have estab-lished coagulopathy2
1 Kauvar, D. et al, Impact of Hemorrhage on Trauma Outcome, J of Trauma; 2006; 60:s3-s11
2 Brohi, K et al, Acute Traumatic Coagulopathy, J Trauma; 2003; 54:1127-1130
The Haemorrhage Problem
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The Haemorrhage Problem: A new USAISR study* finds that nearly 25% of the 4,596 combat deaths
in Iraq and Afghanistan between 2001 - 2011 were "potentially survivable” 87% of the deaths occur prior to reaching a medical facility
91% of potentially survivable deaths were due to uncontrolled blood loss
"Hemorrhage control, both control of torso hemorrhage and junctionalhemorrhage
are top research priorities”
Butler told members of the Defense Health Board on June 25, 2012
3 Eastridge et al. J Trauma Acute Care Surg. 2012; 73 (S431-S437)
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10
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40
50
60
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90
HEMORRHAGE AIRWAY OBSTRUCTION TENSION PNEUMOTHORAX
67,30%
19,20%
13,50%
TRUNCAL
JUNCTIONAL
EXTREMITY
91 %
Joint Committee to Create a National Policy to Enhance
Survivability from Mass Casualty Shooting Events
T H R E AT
1. Threat suppression
2. Hemorrhage control
3. Rapid Extrication to safety
4. Assessment by medical providers
5. Transport to definitive care4
Hartford Consensus
4 Jacobs, L. et al. The Hartford Consensus, J of American College of Surgeons 2013. 217(5), 947-953.
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• Stop bleeding
• Prevent initiation of lethal triad
• Rapid transport to definitive care
Treatment Priorities
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Spectrum of Bleeding Wounds
• Minor wounds:
• Abrasion
• Superficial laceration
• Small puncture
• Gauze with temporary pressure is
effective
• Care priorities:
• Stop bleeding
• Wound protection
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• Difficult to control bleeding:
• Scalp injuries
• Open wounds (e. g. avulsions, punctures,
open fractures)
• Muscle bleeding
• Junctional bleeds
• Arterial bleeds
• Care priorities:
• Stop bleeding
• Other life threatening injuries
• Rapid transport
Spectrum of Bleeding Wounds
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Scalp Lacerations
• Fatal Haemorrhage From Simple
Lacerations of the Scalp5
• Frequent occurrence
• Even “trivial” lacerations of blood-
rich areas such as the scalp may
bleed profusely and persistently
• In one published report5 shown to be
the cause of death in multiple cases
where it was not initially obvious.
5 Hamilton, J.P. et al. Fatal Hemorrhage from simple laceration Forensic Science Medicine 2005; 1(4):267-271
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Spectrum of Bleeding Wounds
• Traumatic amputations:
• Severe soft tissue and skeletal involvement
• Unable to approximate wound edges
• Both – venous and arterial haemorrhage
• Care priorities:
• Stop bleeding
• Other life threatening injuries
• Rapid transport
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• Utilize the most rapid and appropriate method for
hemostasis:
• Direct pressure
• Gauze
• iTClamp
• Haemostatic Agent
• Tourniquet
• Tranexamic Acid (TXA)
Haemorrhage Control Interventions
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• Standard gauze performs
just as well as haemostatic
gauze6.
Direct Pressure / Gauze
• Pressure can be applied
with or without gauze
• Continuous application of
pressure and wound
packing is the key factor in
stopping bleeding, not the
type of gauze6.
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6Littlejohn LF, et all, Comparison of Celox-A, ChitoFlex, WoundStat and combat gauze
hemostatic agents versus standard gauze. Acad Emerg Med. 2011;18(4):340-50
• iTClamp
• Rapid application and
haemorrhage control
• Cessation of blood flow at
the point of injury in seconds
• Maintains distal flow
• Minimal pain
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Trauma Clamp
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iTClamp – Mechanism of Action
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7 Filips, D., et al. The iTClamp controls junctional bleeding in a lethal swine exsanguination model.
Prehospital Emergency Care; 2013; 17(4), 526-532 8 Mottet, K. et al. Evaluation of the iTClamp in a Human Cadaver Model. J of Trauma; March 2014; 76:3
iTClamp: Evidence
• Life Threating haemorrhagic swine
model7
• 100 % treated with iTClamp survived vs.
60 % with standard gauze
• Pre-clinical Cadaver Study7
• 100 % effective at controlling fluid loss
in all compressible zones
• No change with patient movement
• Clinical Use
• Ongoing data collection with clinical use has
shown no failures or adverse outcomes
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• Kaolin Agents (e. g. QuikClot)
• Key ingredient – kaolin clay
• Absorbs water from wound which
increases concentration of clotting
factors
• Chitosan Gauze (e. g. Celox)
• Key ingredient – chitosan
• Swells, gels and clots
• All Haemostatics
• Should be packed into the wound, ideal for cavitating wounds
• Require 3-5 minutes of direct pressure
• Are generally 80% effective with a 30% rebleed rate6
Haemostatic Agents
6Littlejohn LF, et all, Comparison of Celox-A, ChitoFlex, WoundStat and combat gauze
hemostatic agents versus standard gauze. Acad Emerg Med. 2011;18(4):340-50
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• Commercial Tourniquets
• Designed for significant extremity trauma
• Ineffective for junctional bleeds
• Provides circumferential pressure
• Application may cause significant pain
• Despite proper training, approx. 80 % are not tightened
adequately10
Extremity Tourniquets
10 King, D., et al. Forward assessment of 79 prehospital battlefield tourniquets. J of Special Operations Medicine. 2012.12(4), 33-38
11Lee; Emerg Med J Tourniquet use in civilian prehospital setting, 2007;24:584–587.
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• Combat Ready Clamp (CRoC)
• Designed for inguinal and axillary bleeds
• Occludes distal circulation with built-in
compression disk
• Requires device specific training and
assembly
Junctional Tourniquets
• Junctional Emergency Treatment Tool (JETT)
• Designed for massive inguinal groin injuries
• Only effective for lower extremity trauma
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• Tranexamic Acid (TXA)
• For use in suspected or confirmed internal bleeding
• Inhibits clot breakdown
• Must be administered within 3 hours of injury
• Not shown to increase risk of a clotting event (heart attack, stroke,
or pulmonary embolism)12
Anti-Fibrinolytics
12Shakur, H., et al., Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion
in trauma patients with significant haemorrhage (CRASH-2) Lancet. 2010. 376(9734), 23-32.
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Challenges with Current Devices
SLOW: 5 – 15 minutes
LIMITED: No single device works for all injuries
PAINFUL: Cause additional trauma
EXPERTISE: Require medical knowledge and extensive training
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• Mechanism of Injury
• Location of the bleeding:
• Scalp
• Extremities
• Junction
• Abdomen
• Duration of bleeding
• Volume of blood loss
• Number of resources available to
manage the patient
• Transport time to definitive care
Goal: Stop the bleeding!
(LOOK AT THE WOUND, NOT THE DEVICE)
Considerations in
Haemorrhage Management
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Use Case: Scalp laceration
• 36 yo man, hit by baseball bat
• Multiple large scalp wounds
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• iTClamp was placed < 5 sec
• Bleeding stopped < 10 sec
• Comments of the treating physician: iTClamp allowed continious visualization of the head and the possible swelling of the skull. Alternatively a bulky dressing would not have allowed for this assess-ment
Use Case: Scalp laceration
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Use Case: Palmar Artery Laceration
• Man walking with coffee cups falls while holding coffee cup long laceration to palm of hand
• Patient holds manual pressure per self all the way to hospital.
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• Staff relates that when patient removed pressure that blood “pumped” from wound shooting across the room. Patient has lacerated palmer artery.
• Clamp was placed, still with some bleeding, adrenaline soaked gauze added then able to stop bleeding
• Without clamp patient likely would have had temporary closure per ED and a revision per plastics at a later date
Use Case: Palmar Artery Laceration
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Use Case - Crushed Leg
Prehospital
• 36 yo male, whose right leg was crushed in an industrial
accident
• Two tourniquets on thigh due to massive bleeding on
scene
• 2 units pRBCs in helicopter
• BP 180/120, HR 130 on arrival
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Arrival assessment
• Two open wounds
• Large medial wound with open, segmental tibial fracture
• Small 3 cm wound lateral to knee joint with open fibular head
fracture and large degloving injury
• Tourniquet taken down revealing significant bleeding
from smaller wound
• Degloved space packed with haemostatic gauze and
the wound closed over packing with iTClamp
Use Case - Crushed Leg
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ED / Trauma Room Course
• Controlled arterial haemorrhage with iTClamp
• Conduct a complete patient assessement
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Outcome
• Controlling haemorrhage allowed for:
• Complete ED assessment
• A single definitive operation with orthopedic and vascular repair
• Vascular intervention was done in a controlled situation nine (9) hours after arrival
• Bleeding injury was found to be a torn popliteal artery
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• Wounds:
• High velocity
• Entrance / Exit
• Patients:
• Pediatrics
• Geriatrics
• Anticoagulation
• Radiology:
• CT / Xray / Fluro
• No MRI
• Situation:
• Mass Casualty
• Natural Disaster
• Care Under Fire
Special Considerations
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• RULE OF THUMB: Longer wounds – multiple device
• OBVIOUS FEEDBACK when devices not placed correctly
• CAN BE repositioned if needed
• CAN BE USED WITH other haemorrhage control techniques
iTClamp – Device application – Tips and Tricks
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Questions?
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• Bleeding is a significant problem in trauma
• Rapid control of bleeding will affect patient outcomes
• Different strategies (wound closure, packing, pressure,
pharmacological agents) alone or in combination will
provide effective haemorrhage control
• iTClamp is a rapid and easy yet safe and effective
solution for hemostasis by wound closure
Summary
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iTClamp™ Application and Removal Procedures
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The iTClamp™ by
Innovative Trauma Care
instantly controls bleeding by
sealing the skin closed to
create a temporary pool of
blood under pressure. This
forms a stable clot until
surgical repair.
iTClamp – Mechanism of Action
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INDICATIONS For Use:
The iTClampTM50 device is indicated for use as an acute skin closure device for short-term soft
tissue approximation to inhibit severe bleeding in trauma wounds, lacerations, junctional bleeds,
or surgical incisions.
CONTRAINDICATIONS For Use:
The iTClamp50 is contraindicated where skin approximation cannot be obtained (for example,
large skin defects under high tension).
WARNINGS:
• This device is intended for temporary use only; use beyond three hours has not been
studied.
• Patients must be seen promptly by medical personnel for device removal and surgical
repair.
• Only use device as directed to avoid needle stick injury.
• Do not use where delicate structures are near the skin surface, within 10mm, such as the
orbits of the eye.
• Will not control haemorrhage in non-compressible sites, such as the abdominal and chest
cavities.
• Ensure personal protective equipment is utilized to protect against potential splashing of
blood during application.
CE Labeling
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Align needle tips along wound edges
Device application
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Insert needles alongside wound edges and close clamp
• Single gross motor skill
• Can be applied in adverse environments under stress and
during transport
• Applied in seconds with minimal training7,8
• Can be applied over clothing (2 layers of denim)
• Applied with thick gloves
• Can be used on scalp, neck, extremities, axilla, neck and
groin8
iTClamp – Device application
7 Filips, D., et al. The iTClamp controls junctional bleeding in a lethal swine exsanguination model. Prehospital Emergency Care; 2013; 17(4), 526-532. 8 Mottet, K. et al. Evaluation of the iTClamp in a Human Cadaver Model. J of Trauma; March 2014; 76:3
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Close clamp
Bleeding stops
Hematoma forms
Device application
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Additional Bleeding Control
• If bleeding continues:
• Close device more firmly
• Place additional devices for larger wounds (wounds longer than you thumb, require more than one device)
• Remove, reposition & reapply device
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iTClamp Removal / Repositioning
• Remove or reposition the iTClamp if:
• The device was inadvertently closed prior to placement
• The device was positioned incorrectly
• Patient is ready for definitive surgical wound repair
Release Buttons
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iTClamp Removal
• Squeeze the device
• Push in both release buttons
• Allow the pressure bars to open
• Rotate the needles out of the wound
• Remove device and dispose safely
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Questions? For More Information:
www.itraumacare.com
Clinical Support: 1-855-774-4526
Email: [email protected]
US:
North American Clinical Education Manager:
Kim Marie C. Macygin, MSN RN
Email: [email protected]
Europe:
International Clinical Education Manager:
Thomas Semmel, EMT-P
Email: [email protected]
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