A comparison of conventional adult out-of-hospital cardiopulmonary resuscitation against a concept with mechanical chest compressions and simultaneous defibrillation - LINC study

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4 BACKGROUND INFORMATION
Although the number of individuals resuscitated from cardiac arrest has
increased greatly as the years have passed since the first CPR standards were
produced in 1974 [1], the success rate has not increased to any measurable
extent. Only about 6% of victims of out of hospital cardiac arrest survive to
discharge despite resuscitation attempts [2]. This includes those who have
received bystander cardiopulmonary resuscitation (CPR) which can improve
survival by a factor of 2.5 [3]. In Sweden, 1 month survival data from
out-of-hospital cardiac arrest victims have been collected since 1990 and the
figures have varied between 4-7 %. [4].One problem that militates against
greater success is the difficulty to perform effective and uninterrupted
compressions over time. Although the artificial maintenance of blood flow (by
chest compressions) is essential for survival if a shock cannot be given very
quickly, the theoretical 25% of normal cardiac output that might be obtained by
compressions are unlikely to be achieved during the great majority of
resuscitations. Computer print-outs from automated defibrillators show that
compressions are given on average only during 36% of the available
resuscitation time even when performed by experienced rescuers [5].Trained
first responders who compress at a rate of 120/min when providing CPR still end
up with only 38 compressions per minute over the resuscitation time because of
ventilatory and other interruptions [6]. Moreover, the depth of compressions,
even when given by healthcare professionals, is generally appreciably less than
what is recommended in guidelines [7, 8]. Whatever quality is achieved over the
first minute or so rapidly deteriorates if a single rescuer is involved [9].
New methods to achieve consistent and high quality compressions are needed.

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5 STUDY OBJECTIVES
5.1 PRIMARY OBJECTIVE
The primary objective is to show superiority in survival of the modified method
with the LUCAS Chest Compression System, compared to the conventional manual
resuscitation method in patients suffering from out of hospital sudden cardiac
arrest

Primary endpoint is four hour survival from successful restoration of
spontaneous circulation. This will generally mean survival to reach Intensive
Care Unit (ICU) or Cardiac Care Unit (CCU).

5.2 SECONDARY OBJECTIVES
The secondary objectives are to show superiority in survival for the modified
method with the LUCAS chest compression system compared to the conventional
manual resuscitation method in patients suffering from out of hospital sudden
cardiac arrest by measuring the following secondary endpoints:
• Restoration of spontaneous circulation (ROSC) defined as spontaneous palpable
pulse
• Arrival to the emergency room with spontaneous palpable pulse
• Survival to discharge from ICU without severe neurological impairment
(Cerebral Performance Category (CPC) 1 or 2).
• Survival to hospital discharge without severe neurological impairment
(CPC 1 or 2).
• Survival 1 and 6 months after cardiac arrest without severe neurological
impairment (CPC 1 or 2).

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Those randomized to treatment with LUCAS CPR will immediately be treated with
manual compressions with minimized interruptions until the device is unpacked
and ready to use. LUCAS Chest Compression System should be attached to the
patient as soon as possible. In this group the defibrillator need to be in
manual mood.

Mechanical compressions will continue initially for 3 minutes without checking
the heart rhythm, irrespectively if any manual compressions have been given by
bystanders or not. The first shock will be delivered during compressions after
90 seconds into the first 3 minute cycle of LUCAS compressions, followed by 90
seconds of continued compressions. This first shock will be done without
analyzing underlying heart rhythm. Heart rhythm will then be determined after
each 3 minute cycle by interrupting mechanical compressions briefly. This
should be achieved as quickly as possible, never exceeding 10 seconds. If the
analyzed rhythm is shockable, a new 3 minute cycle of compressions will start
including one shock delivered after 90 seconds of ongoing compressions. If the
rhythm is not shockable, a 3 minute cycle of compressions without interruption
will start followed by a new rhythm analysis. Heart rhythm and circulation will
be checked after each 3 minute cycle

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9 ASSESSMENT OF SAFETY
There will be no non-serious adverse event reporting in this study. Events like
rib fractures, sternum fractures and skin bruises are common after
cardiopulmonary resuscitation (CPR) using either method and are not needed to
be reported as adverse events. However, if events including the above mentioned
occur that fall under the Serious Adverse Event definition, they should be
reported as serious adverse events.

9.1 INJURIES FROM CHEST COMPRESSIONS
Autopsy will performed according to a specified Case Report Form (CRF) to
investigate injuries in both study groups. Number of injuries possibly
affecting survival will be studied.
This study will be done in a limited number of centres (Uppsala, Gävle and
Västerås, Sweden). The goal will be to get autopsy results from a total of 300
study patients.

9.2 SERIOUS ADVERSE EVENTS - SAE
SAE is defined as an event directly related to CPR as judged by
investigator/co-investigator and assumed to occur after the randomization in
the study, such as incidents that have resulted in:
• Death
• Serious deterioration of health in patient. This may include
- life threatening illness or injury
- permanent deterioration of body function or structure
- prolongation of hospitalization
-conditions that require medical or surgical treatment to prevent any of the
above

9.3 REPORTING OF SERIOUS ADVERSE EVENTS
The reporting by the Investigator to the Sponsor shall cover all serious AE:s,
including their intensity and cause. The Investigator should report all serious
AE:s by fax or phone to the Sponsor within 24 h from receiving knowledge of
the event. The Investigator should use a Serious Adverse Event Report form
included in the CRF file.

The Investigator*s initial report of serious AE:s should as far as possible be
supplemented by detailed information on diagnosis/symptoms, and any further
relevant data by a follow-up report within 7 days.

Information about SAE will be forwarded to all study sites and when applicable
to the MPA by the sponsor.


9.4 ADVERSE DEVICE EVENTS - ADE

ADE is defined as any untoward and unintended response of the device, leading
to that the protocol was not fulfilled due to technical issues or other
circumstances. It may also include injuries on LUCAS operators or another
person than the patient, which can be directly related to the device. If an
ADE occurs it should be reported within 24 hours to Jolife AB, by filling an
ADE report in the CRF file. The ADE will be handled according to Jolife
ordinary quality system.