Measurement of the Quality of Pediatric CPR
Condition: Cardiac Arrest
MeSH terms: Heart Arrest
Study type: Observational

Summary: 
      Outcomes for pediatric cardiopulmonary resuscitation (CPR) are suboptimal. CPR quality is
      directly related to resuscitation outcome, yet numerous deficiencies in CPR quality have been
      documented in adult studies. While similar deficiencies can be expected in pediatric
      resuscitation attempts, there is little to no data evaluating the existing quality of CPR
      performed during resuscitation attempts. Therefore, the objective of this study is to
      quantitatively evaluate existing CPR quality using a Q-CPR compression sensor manufactured by
      Philips Medical Systems with technology from Laerdal Medical.
    

Detailed description: 
      In the event of a cardiac arrest in the pediatric intensive care unit, a 24 hour paging
      system will notify the Cardiac Arrest Research Team to facilitate data collection. This
      system has been active as part of The Children's Hospital of Philadelphia (CHOP)
      Institutional Review Board (IRB) Protocol No. 2006-6-4839, and has resulted in capture of
      more than 95% of eligible events.

      Cardiac arrest events requiring chest compressions in the PICU (pediatric intensive care
      unit) involving children greater than or equal to 1 year of age, but less than 8 years of age
      and who were previously screened, identified, and who have provided written consent are
      eligible for study. CPR quality will be recorded with the modified Heartstart MRx with Q-CPR
      Option, an external defibrillator with a chest compression sensor interposed between the
      hands of the rescuer providing chest compressions and the sternum of the patient. The device
      to be used is a regular Heartstart MRx with Quality of CPR (Q-CPR) Option cleared under
      510(k) Premarket notification - K051134, but which has been modified for this study. In its
      current version, Q-CPR Option is approved for patients ≥ 8 years of age and has been utilized
      in the CHOP Pediatric Intensive Care Unit (PICU) under CHOP IRB Protocol No. 2006-6-4839.
      This Q-CPR Option on the Heartstart MRx has been modified for this study to accommodate
      children 1 year to less than 8 years of age. Since the device has been modified for use in
      this study, the device is an Investigational Device during this study regulated by the IDE
      regulation (CFR 21 Part 812). FDA has determined through a pre-investigational device
      exemption (IDE) process (I090674) that the use of the Heartstart MRx with the modified Q-CPR
      Option in a non-significant risk (NSR) device study. Two primary modifications were done on
      the Q-CPR Option: 1) changing the size of the compressions sensor footprint that interfaces
      with the patient's chest and 2) disabling the audiovisual Q-CPR feedback. Specifically the
      contact area of the compression sensor has been reduced to better mimic the area of the heel
      of a hand - the current recommended interface between the CPR administrator and the patient's
      chest during usual CPR / resuscitative care. Furthermore, no audiovisual feedback will be
      provided for this patient group as absolute measurement-based CPR quality targets do not
      exist for this age group. The device records CPR parameters (depth and rate of chest
      compressions), as well as electrocardiographic (ECG) data, and defibrillation shock data (if
      used). The pad relays this information to a recording component on the defibrillator which
      stores such data onto an internal data card. Once the cardiac arrest is completed, the MRx
      data can be exported to an external data card and downloaded to a secure laptop.

      The investigator will use the Study Data Collection Form I in the Appendix to collect
      additional information immediately after resuscitation event has concluded. The patient's
      medical record will also be accessed and data will be collected as specified in the Medical
      Record Data Collection Form II. In addition to medical information, data collected will also
      include the post arrest chest depth in centimeters (cm) of the patient, chest circumference
      (cm) and details of the mattress and bed on which the child was resuscitated. Phase 2
      procedures will be identical to those employed as per CHOP IRB Protocol No. 2006-6-4839.
    

Intervention name(s): There is no intervention for this study.
Intervention type(s): Device
Intervention description(s): There is no intervention for this study. The pre-NSR IDE for this study is simply a modification to allow for recording of data without intervention.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Cardiac arrests (chest compression events) occurring in the pediatric intensive care unit
        having consented for enrollment in the study.
      
Keywords: Cardiac arrest, CPR, pediatric