Feasibility of Ventilation Detection Via Standard Defibrillator Pads in Mechanically Ventilated Pediatric Patients
Condition: Respiration, Artificial
Study type: Observational

Summary: 
      This study is a prospective, observational case series of a convenience sample of
      mechanically ventilated pediatric patients in the Pediatric ICU, Progressive Care Unit and
      Operating Room at the Children's Hospital of Philadelphia.

      We propose to observe, measure and report the accuracy, precision and bias of defibrillator
      electrode pads to detect breathing in stable but critically ill and mechanically ventilated
      children. This study will provide preliminary data to inform the resuscitation research
      community and assist development of evidence-based pediatric resuscitation guidelines in the
      future.
    

Detailed description: 
      Context: Resuscitation (CPR) guidelines recommend target values for rate and depth of rescue
      breathing and chest compressions. Defibrillator electrode pads can accurately detect the
      size, rate, and speed of machine-generated breaths in adults. The accuracy, precision, bias,
      and ability of the defibrillator electrode pads to detect the size, rate and speed of
      breathing in children have not been studied.

      Objectives: The primary objective is to evaluate the accuracy, precision, bias and ability of
      the pads and defibrillator to detect the rate and depth of breathing in critically ill
      children on breathing machines. Important secondary objectives include reporting the
      accuracy, precision and bias of the measurement of the speed of the breath, measurement
      variability, and impact of alternative defibrillator electrode pad location on the chest.

      Study Design/Setting/Participants:

      Prospective, pilot, observational study in the Pediatric Intensive Care Unit and Progressive
      Care Unit at the Children's Hospital of Philadelphia. The participants are all patients in
      the PICU and Progressive Care Unit (PCU), 6 months to 17 years, who are supported by their
      clinical management team with a tracheal tube, standard breathing machine, and standard ICU
      monitoring systems.

      Intervention:

      Standard defibrillator electrode pads will be placed on the patient's chest in two typical
      pediatric configurations, and data will be recorded for 5 minutes in each configuration.
      These defibrillator electrode pads will be used exclusively for monitoring, as additions to
      the standard ICU monitoring.

      Study Measures:

      The primary outcome variable will be the successful detection of breathing rate. We will
      compare the accuracy, precision and bias of detection of each breath of > 2 ml/kg by the
      defibrillator electrode pads compared with the "gold standard" mechanical ventilator
      pneumotachometer detected breaths. Secondary outcome variables will include defibrillator
      electrode pad detection of breathing depth and speed compared to standard ICU monitors
      (considered the gold standard). We will also study the effect of defibrillator electrode pad
      location on the accuracy, precision, bias and ability to detect breathing rate, depth, and
      speed.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients admitted to the Pediatric Intensive care Unit, Progressive Care Unit or
        Operating Room at the Children's Hospital of Philadelphia
      
Keywords: mechanical ventilation; thoracic impedence; defibrillator pads; ventilation detection; pediatric ventilation