Best Practices in EMS: From Gestalt to Scene

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Best Practices in EMS From Gestalt to Scene

• Dianne L. Atkins, MD
• University of Iowa
• Childrens Hospital of Iowa

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Best Practices in EMS From Gestalt to SCIENCE to
Scene

• Dianne L. Atkins, MD
• University of Iowa
• Childrens Hospital of Iowa

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Fatal Disease to Long-Term Remission

• In 1970, childhood leukemia was virtually always
  fatal
• By 1990, 85 long-term (gt20 years) remission

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Where Are We in Resuscitation Research

• Consensus evidence (Whose voice is the loudest?)
  
• Written guidelines
• Very few randomized controlled trials
• Practices become standard, routine prior to
  validation
• Evidence-based practices are the goal

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Practice 1 Defibrillation

• Automated external defibrillators
• First released by FDA in 1996
• Brand new technology
• Algorithm to detect ventricular fibrillation
• Biphasic waveforms
• Fire extinguisher analogy, e.g. minimal training
• Assumptions
• Defibrillation alone would increase survival
• Anybody could (and would) use them

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AEDs within EMS

• Proven efficacy within EMS systems
• Proven efficacy when used by trained
  public-safety personnel with a duty to respond
• Police
• Airline attendants
• Security guards

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What About the Lay Public?

• Public Access Defibrillation Trial
• Funded 2000-2003, NIH, AHA, manufacturers
• Community-based randomized controlled trial
• 19,000 trained volunteer responders, 993
  locations, 93 North American regions
• Public (85) and residential facilities (15)

NEJM 351637-646, 2004
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PAD Trial Results
NEJM 351637-646, 2004
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Conclusions from PAD Trial

• use of AEDs by trained volunteers is safe and
  effective when initiated in public locations
  where there is at least a moderate likelihood of
  an out-of-hospital cardiac arrest
• widespread implementation of public AED
  programs could result in 2000-4000 lives saved
  each year
• First trial for cardiac arrest to show improved
  hospital discharge!!

NEJM 351637-646, 2004
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Shortcomings of PAD Trial

• 80 of cardiac arrest occur at home, not a public
  location
• 8000 volunteers trained at least twice
• Attrition rate was 18 per year
• Volunteer response system activated in 53 (CPR)
  and 70 (CPRAED) of events
• CPR administered 64 of events.

NEJM 351637-646, 2004
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Practice 2 CPR

• High quality CPR is vital to cardiac and cerebral
  resuscitation
• Manual compressions at recommended rate, depth,
  and release are hard to maintain
• Hands off time is high
• Difficult and dangerous to perform in some
  settings transfer and transport
• Test an automated CPR device

Ornato, JAMA 2006
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AutoPulse Resuscitation System

• Load-distributing band circumferential chest
  compression
• Rhythmical squeezing effect, 80 cpm
• Battery powered, 15.8 kg
• Animal data indicated better survival and
  neurologic outcomes
• http//www.zoll.com/

Ornato, JAMA 2006
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Advantages of AutoPulse

• Circulates blood in the patient during cardiac
  arrest.
•  Compact and portable.
•  Deploys in seconds.
•  Easy to use.
•  Consistent depth and rate of compressions.
•  Reduces rescuer fatigue.
•  Reduces interruptions during code and
  transport

ZOLL.com
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Richmond VA

• Non-randomized observational study with
  historical controls
• All patients during each time frame were treated
  the same
• Previous CPR recommendations used

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ASPIRE Design

• Randomized, controlled trial of AutoPulse
• Primary endpoint 4 hour survival after 911 call
• Secondary endpoints Hospital discharge and
  cerebral performance category score

JAMA 2952620-2628, 2006
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ASPIRE Results

• Trial halted early after planned interim review

JAMA 2952620-2628, 2006
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Potential explanations

• Hawthorne effect Manual CPR improved within the
  study
• Learning curve of using device
• Last two months similar to first months
• Enrollment bias Attempts with device when
  patient was dead
• Delay in implementation in device group
• Device is harmful or increases hands-off time at
  critical point

JAMA 2952620-2628, 2006
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Implications

• Role of cohort, historical control trials
• Animal data generated under very tight conditions
• Post-resuscitation care
• Characteristics of EMS locally
• Device is VERY expensive
• Purchased device based on manufacturer, animal
  data

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Practice 3 Epinephrine

• Epinephrine needed to increase coronary perfusion
  pressure
• Increases blood pressure by constricting blood
  vessels, increasing force of contraction
• Maybe more is better??
• Increase oxygen requirements of heart, decrease
  blood flow to vital organs

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Consensus Recommendations

• Retrospective, study with historical controls
• Added to AHA guidelines in 1992, 1997
• Routineuse before controlled studies performed

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Randomized HDE Trials

• Multiple trials in animals, adults and children
• Ineffective
• Worse neurologic outcomes
• Now a Class III (harmful recommendation)

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But When to Intubate?

• Randomized controlled clinical trial in Orange
  County, California
• Cardiac arrest patients lt 12 years or lt 40 kg
• 820 patients analyzed
• Intubation vs. Bag-valve mask
• Short transport times 4-8 minutes

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Training for Trial

• ETI not a scope of practice for pediatrics before
  trial
• All paramedics had two 3-hour educational
  sessions
• Mannikin training
• BVM Squeeze-release-release
• Ventilation rate 20/minute

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Outcomes

• Hospital discharge
• Neurologic status at discharge
• Effectiveness of ventilation O2 saturation
• Complications of intubation
• Main stem intubation
• Recognized dislodgment
• Unrecognized dislodgment
• Esophageal intubation

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Results
Gausche et al JAMA 2000
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Outcomes

• ETI was worse for subgroup of patients
• Respiratory arrest
• Foreign body aspiration
• Abuse
• No difference in all other categories
• Trauma, head injury, drowning, CA, asthma,
  seizure

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Study Conclusions

• Endotracheal intubation does not improve survival
  or neurologic outcome of pediatric patients in an
  urban EMS system.
• Does this extrapolate to all systems
• Need for alternate airways

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What Does This Have to do with Cancer?

• Complex, multifactorial problem
• Small numbers locally, large nationally
• Cooperation
• Incorporation of new knowledge along the way

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How Did this Happen?

• Childrens Cancer Study Group
• Methodical, stepwise approach to treatment
  protocols
• Performed nationally EVERY child with cancer
  was enrolled
• Initial endpoints were surrogates for cure

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Whats the Good New?

• Resuscitation Outcomes Consortium
• NIH funded
• 50 Million
• NHLBI, Stroke, CIHR, AHA, CHA
• On-scene, randomized interventions for cardiac
  arrest and severe trauma
• Database of ALL cardiac arrest and severe trauma
• The EMS research opportunity of the
  century Dr. Joe Ornato

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Resuscitation Outcomes Consortium
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Trauma Trial

• No change in resuscitation fluid for 40 years
• Hypertonic Saline-Dextran trial for patients
  with severe hemorrhage or traumatic brain injury
• Patients receive 250 cc ofinvestigational fluids
  or placebo

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Cardiac Arrest Trial

• Impedance threshold valve
• Enhances CPR blood-flow with an airway valve
• Increases venous return to the heart
• Can be added to BVM, endotracheal tube, combitube
  or LMA

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Timeline

• Funded September 2004-April 2009
• First protocol submitted to regulatory committees
  Dec 2004
• First patient enrolled Spring 2006
• Canada May 2006
• US August 2006
• Second protocol submitted April 2005
• Just received final approval this week!
• Longest time from funding to patient enrollment
  at NHLBI

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WHY??

• Regulatory bodies
• Office Human Research Protection
• NIH Protocol Review Committee
• FDA
• Individual Institutional Review Boards
• Each EMS agency and hospital
• Iowa 12 EMS agencies, 20 hospitals, 13 IRBs

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45 CFR 46 Waiver of Informed consent in
Emergency Research

• FDA Final Rule
• A life-threatening situation that necessitates
  intervention
• Direct benefit to the subjects is supported by
  appropriate animal and other preclinical studies
  related evidence
• The risks are reasonable given what is known
  about the medical condition and the risks and
  benefits of standard therapy,

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45 CFR 46 Waiver of Informed consent in
Emergency Research

• Media Advertisements / Community Meetings /
  Community feedback
• Patient given enrolled in trial without initial
  consent
• Patient/family consent needed for continued
  enrollment and data collection

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Obstacles to EMS Research

• Obstacles
• Consent issues
• Legislative support for emergency care trials
• Funding
• EMS provider devotion to research efforts
• Data collection from the field

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Getting the Best Practices to the Scene

• It takes critical thinking
• It takes chosen tests and endpoints
• It takes patience
• It takes a lot of money

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Where is the Fire Extinguisher? Is there an AED
here?
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Necessary Personnel for CPR
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