Transcript The ResQ Trial - Whatcom County EMS Council

“Possibly, by focusing so much attention on
discovering more effective drugs and more
sophisticated defibrillator technology, we have lost
sight of the vital importance of more mundane
therapies, such as timely and proper provision of
rescue breathing and chest compressions.
Perhaps those who research cardiac arrest are
guilty of the same oversight made by resuscitation
team leaders – we have all been looking at the
wrong aspects of the resuscitation attempt.”
Stephen Pitts, Arthur L. Kellerman
(Lancet 2004;364:314)
The ResQ Trial:
Comparison of
Standard Cardiopulmonary Resuscitation (S-CPR) Alone
vs. Active Compression Decompression CPR (ACD-CPR) Plus an
Inspiratory Impedance Threshold Device (ITD) (ACD-CPR+ITD)
on Survival from Out-of-Hospital Cardiac Arrest
Learning Objectives
After completing this course you will be able to:
1. Briefly describe the study objectives and your role in
the ResQ Trial.
2. List the patient inclusion/exclusion criteria.
3. State the purpose of the randomization calendar and
the method your agency uses to insure the calendar is
followed correctly each week.
4. Describe the correct performance of standard CPR
(with the modified hand position) and use of the AED
according to current AHA guidelines.
5. Describe the correct performance of active
compression-decompression (ACD-CPR) with the
ResQ Pump and ResQ POD.
Agenda
• Study presentation
• Manikin practice
• Skills evaluation
– Standard CPR with modified hand position
– Use of an impedance threshold device (ResQ
POD)
– Performance of active compression
decompression CPR with the ResQ Pump
• Written evaluation
– 80% correct (at least 12/15 questions correct)
Funding Support
Funding for this study is being provided by the
National Institute of Health (NIH) grant
#2-R44-HL065851-03 to Advanced Circulatory
Systems, Inc. (ACSI), Eden Prairie, MN;
Keith G. Lurie, MD, Principal Investigator.
The contents of this presentation are solely the
responsibility of ACSI and do not necessarily
represent the official views of the NIH National
Heart, Lung and Blood Institute.
Study Purpose
Evaluate the ability of two investigational
devices to make Standard CPR
(S-CPR) more effective:
Active Compression Decompression
CPR (ACD-CPR)
– Performed with a ResQPump®
Impedance Threshold Device (ITD)
– ResQPOD®
Why Does CPR Work?
“Cardiac Pump” Theory
Blood flow during CPR is due to the direct
compression of the heart between the
sternum and the spine.
May play particularly
important mechanistic
role in early phases of
CPR (valves lose
competence after
prolonged CPR).
“Thoracic Pump” Theory
• Ribs & sternum act as a
bellows.
• During chest compression,
increased intrathoracic
pressure, aided by one-way
valves in the heart and venous
system, cause forward
movement of blood through
the circulatory system.
Decompression Phase
• Blood returns to the heart during the
relaxation (decompression) phase of
CPR.
• A small, but important, vacuum
(negative pressure) forms in the chest
relative to atmospheric pressure and
draws blood back into the chest and
heart.
• The more blood that returns to the
heart (preload), the more that is
circulated forward (cardiac output) on
the next compression.
CPR with Incomplete Chest Relaxation
0 mmHg
The desired negative pressure within this patient’s chest is never achieved.
“Allowing complete chest recoil after each
compression allows blood to return to the
heart to refill the heart. If the chest is not
allowed to recoil/re-expand, there will be
less venous return to the heart, and filling
of the heart is reduced. As a result, cardiac
output produced by subsequent chest
compressions will be reduced.”
Highlights of the 2005 American Heart Association Guidelines for
Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Currents
in Emergency Cardiovascular Care. Vol. 16 No. 4, Winter, 2005-2006
Device Mechanisms
• Goal: Enhance the negative pressure
(or vacuum) in the chest during the
decompression phase of CPR in order
to return more blood to the heart.
• ResQPump: Begins the creation of the
vacuum
• ResQPOD: Sustains the vacuum that is
created
Study Design
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Prospective (using only “new” data)
Randomized
Multi-center (Whatcom Co. is 1 of 6 sites)
Waiver of Informed Consent
Sponsored by Advanced Circulatory Systems,
Inc. (Eden Prairie, MN)
• Funding support: NIH
• Timeline: approximately 3 years to complete
Study Sites

MN: City of St. Paul (R. J. Frascone, MD)
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
MN: City of Minneapolis (Brian Mahoney, MD)
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Minneapolis FD & Hennepin Co. EMS
WA: Whatcom Co. EMS (Marv Wayne, MD)
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Including Bellingham FD
MI: Oakland & Macomb Co. (Bob Swor, MD)
WI: City of Oshkosh (Tom Aufderheide, MD)
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
St. Paul FD
Oshkosh FD
MI: Ann Arbor (Bob Domeier, MD)
Waiver of Informed Consent
• Permitted by federal regs: 21 § CFR 50.24
• Qualifications
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Life-threatening situation
Obtaining informed consent is not feasible
Prospect of direct benefit
Research could not be done without a waiver
Additional protections (next slide)
Waiver of Informed Consent
• Additional Protections
– Community Consultation
– Public Disclosure
– Data and Safety Monitoring Board (DSMB)
– Subsequent Notification
– Written Informed Consent for continued
participation
Community Consultation
• Open public meeting
– Date/Time: June 30, 2005, 7-9PM
– Location: Health Education Center
• Surrogate community from which
research subjects will be drawn
– Variety of organizations & stakeholders
• No veto power
Public Disclosure
• Communities in which study will be
conducted; e.g.:
–
–
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Newspaper announcement
Radio/TV spots
Community organization newsletter
Website
• Plan for the investigation
• Risks and expected benefits
• Contact information
Data and Safety Monitoring Board (DSMB)
• Independent
• Comprised of experts
– e.g.: emergency medicine, neurology,
bioethics, statistics, cardiology,
anesthesiology
• Responsible for oversight of safety
– Monitor @ regular intervals
• Authority to halt study
CONFIDENTIALITY
EMS personnel’s role is to
maintain confidentiality of
patient information at all
times.
Randomization
• Definition: [n] The process of assigning study
subjects to treatment (experimental) or
control (standard of care) groups using an
element of chance to determine the
assignments in order to reduce bias.
• Extremely important to follow when
conducting research
– Intention to treat
Intention to Treat
• Patients will be analyzed in the group
that they should have received, not
what they actually got.
• Extremely important
– Follow the schedule exactly
– Implement the devices ASAP
– Report errors
Study Randomization
• 2 arms
– #1: CONTROL: Standard CPR (S-CPR)
– #2: EXPERIMENTAL: ACD-CPR + ITD
• Weekly randomization
– equal, but randomly applied
– week will begin on Sundays at 8AM
– schedule is computer-generated and known in
advance
List at least two locations where you can find a copy of the
calendar in your agency?
Getting the Word Out
Things we’re going to do in our system to
make sure everyone knows what method
of CPR they’re supposed to be
performing:
1. Device availability (in color-coded bags)
2. Color-coded ResQ Trial calendar posted
3. Resource Guide in each vehicle
(“rig folder”)
Study Protocol (3100 pts)
Cardiac Arrest
Randomize by week
S-CPR
ACD-CPR + ITD
Standard Treatment
• Intubation
• Defibrillation
• IV & medications
Outcome
BLS & ALS Care
• Only difference will be CPR method
• Important: Equally aggressive regardless of
CPR method
• ResQPOD can be applied to:
– Facemask (FIRST!)
– ET tube (most preferred airway)
– Combitube
• Length of resuscitation: minimum 30 minutes
Exceptional CPR Quality
• Follow correct compression rates:
– S-CPR: 100/min
– ACD-CPR: 80/min
• Allow chest to completely recoil
• Do not hyperventilate
– Facemask: 30:2 compression to ventilation ratio
– Advanced airway: 8-10/min
• Provide each ventilation over 1 sec
• Avoid interruptions of CPR longer than 10 s
Example:
Vent rate:
48/min
Switch
Chest pressure
seldom becomes
negative
The DANGER of Hyperventilation
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Seven pigs
V-fib for 6 min
Comp: 100/min
Vent: 30/min
CPR for 6 min
Shock(s) as nec
Survival: 1/7 (14%)
•
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Seven pigs
V-fib for 6 min
Comp: 100/min
Vent: 12/min
CPR for 6 min
Shock(s) as nec
Survival: 6/7 (86%*)
*P<0.05
Inclusion Criteria
• Adults known or presumed to be ≥ 18 yrs
• Presumed* non-traumatic cardiac arrest
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Cardiac etiology
Respiratory etiology
Stroke
Overdose
Smoke inhalation
Drowning
Burns
Metabolic imbalance
Seizures
*If you are uncertain, presume it is non-traumatic until you discover otherwise
Exclusion Criteria
• Known or presumed < 18 years
• Obvious or likely traumatic etiology
– Penetrating or blunt trauma
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Pre-existing DNR orders
Obvious signs of clinical death
Family members who request exclusion
For ACD-CPR+ITD arm: recent sternotomy
(wound not appearing completely healed or,
if known, < 6 months)
Study Endpoints
• Primary: Survival to hospital discharge
• Secondary:
– Return of spontaneous circulation (pulse)
– Survival to: 1-hour, 24 hours, ICU
admission, 30 days, 90 days & 365 days
– Neurologic recovery @ hospital discharge,
and 30, 90 & 365 days
– Adverse events & complications
Study Scene Monitor
• Research personnel will be making
random scene responses to
– Monitor quality of CPR
– Make sure devices are being used properly
– Act as a resource in the field
Name at least one way to find the answers to your
questions about adult CPR and the ResQ Trial.
Run Follow-up
• Complete patient care record accurately
• Call in to research hotline (24/7)
– 1-866-640-2832
– ALL ARRESTS; regardless of whether entered
and regardless of resuscitation attempted
• ResQPOD: place sticker on run report;
dispose of ResQPOD unless there were
problems; replace with new
• Clean ResQPump and reuse; record device
number on run report
Benefits to Patients
• Possibly an opportunity for improved
survival (but this is not guaranteed and
is unknown at this time)
• Opportunity to contribute to the scientific
knowledge base that may benefit others
• Patients in the control group may
benefit as well
– Hawthorne effect
Risks to Patient
• Vomiting during CPR (EMS hotline report)
• Chest fractures (verified by CXR)
• Pulmonary edema (EMS hotline report: airway
fills with fluid twice; and/or CXR)
• Organ damage (chart review or autopsy)
• Chest bruising or redness (EMS hotline report)
• Death (EMS hotline report and chart review)
• Survival with neurologic damage (chart review)
• Device performance/failure (EMS hotline report)
Hotline Report
(example questions)
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Did you attempt resuscitation on the patient? If not, why?
Was the patient believed to be at least 18 yrs old? If not, age:
Was the likely cause of the arrest non-traumatic?
Was the likely cause of the arrest presumed to be cardiac?
Did the patient have preexisting DNR orders or did you stop efforts
early because of the family’s
request?
Did family or bystanders request that the experimental devices not be
used?
Did the patient have a recent sternotomy?
Was the patient a prisoner?
Was the patient known or suspected to be pregnant?
Did EMS perform 1-59 seconds of CPR on the patient?
Did the patient have a complete airway obstruction that could not be
cleared?
Did you attempt to intubate the patient with an ET tube or Combitube?
If yes, were you successful?
Standard CPR (S-CPR)
• Package with facemask only
• Airway not secured (facemask)
– Compression to ventilation ratio 30:2
– Compress to 1.5 - 2” & allow complete recoil with modified
hand position
– Compress at rate of 100/min but pause for breaths
– Ventilate over 1 second
• Airway secured (ET or Combi-tube)
– Compress continuously @ 100/min; do not pause for breath
– Compress to 1.5 – 2” & allow complete recoil with modified
hand position
– Ventilate at 8-10/min (1 breath about every 6-8 seconds)
– Ventilate over 1 second
Hand Positions for S-CPR
Old
New
ResQPump™
Metronome
Force Gauge
Suction Cup
Handle
ACD-CPR
Compression
• Same as standard CPR
• 1 ½ - 2”
• Compression rate 80/min
Body position
is critical to
avoid fatigue.
Perform CPR
at patient’s
side.
Rotate
compressor
role @ every 2
minutes.
ACD-CPR
Decompression
 Lift until force gauge
reads approx.
–20 to –30 lbs
Most common error is
failure to actively
decompress chest
ACD-CPR + ITD
• ResQPump & package with facemask, ResQPOD &
sticker
• Place ResQPOD on facemask ASAP
– Hold tight facemask seal at all times
• Airway not secured (facemask)
– Compression to ventilation ratio 30:2
– Compress to 1.5 - 2” with active decompression (use gauge)
– Use ResQPump & compress @ 80/min (metronome); pause
for breaths (less than 10 sec)
– Ventilate over 1 second
• Airway secured (ET 1st choice)
– Compress continuously @ 80/min (metronome); do not
pause for breaths
– Compress to 1.5 – 2” with active decompression (use gauge)
– Move ResQPOD to airway and turn on timing assist lights
– Ventilate according to lights or 8-10 breaths/min
– Ventilate over 1 second
Hand placement to
maintain a tight seal
Two-person rescue breathing*
One person rescue breathing
*The two-handed technique is
preferred. When it’s time to
pause compressions to give the
breaths, the person doing chest
compressions can reach over
and squeeze the ventilation bag.
ResQPOD with an ET Tube
The timing-assist lights
should be turned on to
guide ventilation rate (or
8-10 breaths/min.) only
after an advanced
airway is placed.
(Disconnect the ResQPOD to deliver meds thru ET tube, then
reconnect and continue ventilations.)
The ResQ POD is a CPR Tool
If CPR is in
progress…
When pulse
returns…
ETCO2 Monitoring
Place the ETCO2
sensor between
the ventilation
source and the
ResQPOD.
Troubleshooting
• Timing assist light function is independent of
inspiratory impedance valve feature.
• If timing assist lights fail to operate or appear
to blink at a rate different than  10/minute,
disregard the lights, continue using the
ResQPOD, and ventilate the patient at 8-10
breaths/minute.
• Discontinue ResQPOD if:
– Chest does not rise with ventilation
– Device appears to malfunction in any way
– The POD fills with fluid twice
(the airway may be suctioned as needed)
Troubleshooting
ResQPOD Fills With Fluid
• Clear fluids or secretions from the ResQPOD by
removing it from the airway adjunct and blowing out
debris using the ventilation source.
• Discontinue use if the device cannot be cleared.
• Discontinue use if the ResQPOD fills with fluid more
than once.
– May replace POD with new one (preferred), or d/c
completely
– Suctioning of tube (w/o fluid in POD) does not require that
the POD be discontinued
• If any problems with the ResQPOD, save in a red
bag and return to study coordinator
Troubleshooting
ACD-CPR
•
Suction problems in 10-15% of patients
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May interfere with AP patch placement
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Check placement and continue
Hickey or bruising to chest
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Rotate frequently
Rib fractures
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Move patches
Requires 25% more rescuer energy
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Reposition, shave, or dry off chest
Continue use unless distracting
Continue
Discontinue use if device appears to malfunction.
ResQ Pump Cleaning/Reuse
• Clean cup with soap and water.
• May be cleaned with bleach solution or
other disinfectant.
• Check gauge for proper calibration.
Untrained Healthcare Providers
Do not leave the
ResQPOD or
ResQPump in the
hands of healthcare
providers who have
not been trained in
their use.