Utility of Continuous Pulse Oximetry for Pediatric Patients With Stable Respiratory Illness
Condition: Respiratory Disease; Asthma in Children; Pneumonia in Children; Bronchiolitis Acute
MeSH terms: Bronchiolitis; Respiratory Tract Diseases; Respiration Disorders
Study type: Interventional

Summary: 
      This is a randomized, prospective study to determine if there is a difference in hospital
      length of stay between patients receiving continuous hardwire cardiorespiratory monitoring
      and those receiving intermittent vital signs measurements among pediatric patients admitted
      for uncomplicated respiratory illness.
    

Detailed description: 
      Respiratory illnesses are among the most common causes for inpatient pediatric
      hospitalizations every year. The most common respiratory illnesses that make up these
      hospitalizations include pneumonia, acute bronchiolitis, and asthma.

      Pneumonia is one of the top three illnesses requiring pediatric hospitalization and is a
      significant cause or morbidity and mortality. The incidence of pediatric pneumonia varies
      depending on the country and age group, but worldwide the annual incidence in children
      younger than five years of age is 150 million and approximately 2 million pediatric deaths,
      per year, are attributed to pneumonia. Therefore, it is important to understand this disease
      and how it impacts pediatric hospital admissions.

      Pneumonia is defined as an acute infection of the lung parenchyma secondary to an infectious
      etiology such as viruses or bacteria. When an infectious organism is present, the defense
      mechanisms of the body, including the lungs, are disturbed and the resultant inflammation
      gives rise to parenchymal damage. Symptoms can include fever, cough, and shortness of breath.
      Findings on imaging can demonstrate infiltrates in the lungs. Vital sign testing can show
      elevations in a child's heart rate and decreases in the amount of oxygen present in the blood
      (pulse oximetry) secondary to the infiltrative processes in the lungs.

      Pneumonia is the most common serious infection in the pediatric population and accounts for
      up to 1-4% of all pediatric Emergency Department (ED) visits in the United States (US).
      Furthermore, of the pediatric patients that present to the ED with pneumonia, 20-25% are
      admitted to the inpatient pediatric unit for further management. This decision to admit a
      child to the hospital depends on various underlying factors including age, medical
      conditions, and severity of illness. One of the factors that is considered when deciding
      whether to admit a child to the hospital for pneumonia is oxygen saturation, or the amount of
      oxygen in the blood.

      Bronchiolitis is another common respiratory illness in the pediatric population and is
      estimated to account for up to 100,000 US hospital admissions annually. There is a
      seasonality with most infections occurring in the fall and winter months. It is the leading
      cause of hospitalization in infants and young children with most cases involving children
      less than two years of age.

      Acute bronchiolitis refers to lower airway inflammation and obstruction secondary to a viral
      infection. When a virus infects the terminal bronchiolar epithelial cells of the lower
      airways in the lungs, damage to these cells results and subsequently causes cellular
      sloughing and inflammation. This inflammation, coupled with mucous build-up, accounts for the
      obstruction that is seen in acute bronchiolitis. Symptoms include rhinitis, congestion,
      cough, tachypnea, wheezing, and accessory muscle use. Like pneumonia, hypoxemia (decreased
      oxygen content in the blood) can occur with acute bronchiolitis with the most severe
      complication being acute respiratory failure requiring mechanical ventilation.

      The third most common respiratory illness that accounts for pediatric hospital admissions is
      asthma. Asthma affects 1 in 12 children in the US and is a leading cause of ED visits. It is
      the most common chronic disease in childhood in developed countries and an estimated 8.3% of
      children in the US had been diagnosed with asthma in 2016.

      Asthma is a complex, multifactorial, immune-mediated disease and is defined by episodic and
      reversible airway constriction and inflammation. Triggers for asthma exacerbations can
      include infections, environmental allergens, and other irritants. Smooth muscle constriction
      in the airways and inflammation/edema result in intermittent and reversible lower airway
      obstructions. Symptoms of asthma include cough, wheezing, shortness of breath, and chest
      tightness. Like the other respiratory illnesses mentioned, asthma can also result in
      hypoxemia.

      Respiratory illnesses, including pneumonia, acute bronchiolitis, and pneumonia pose a
      significant threat to the pediatric population and are major causes of morbidity and
      mortality throughout the world. In the US, most pediatric hospital admissions are secondary
      to these illnesses and determining how to best monitor and manage these patients while in the
      hospital is important. Specifically, the most ideal technique to monitor for hypoxemia is one
      of current debate.

      Currently, there are two main ways to monitor for hypoxemia in a hospital setting. The first
      is to have a pediatric patient on continuous monitoring, which involves the child being
      continuously connected to a monitor that displays various vital signs, one of which being
      oxygen saturation (SpO2). This technique has been studied over the last several years and
      many concerns have been raised regarding alarm fatigue, or the phenomenon that occurs when a
      patient is continuously connected to a monitor and the monitor alarms an overwhelming amount.
      One study found that this form of monitoring was used in up to 50% of children in non-ICU
      settings and that up to 99% of the alarms did not require clinical action. In fact, this
      study found that more than 10,000 alarms can occur in a pediatric unit in 1 week and that
      greater than 150 alarms can occur on any one patient each day. Furthermore, while these
      continuous monitors are meant to identify patients who are deteriorating, it has been
      suggested that the efficacy is limited by alarm fatigue and that evidence has not shown them
      to improve patient outcomes. Finally, a recent study also demonstrated that the second form
      of monitoring, scheduled vital checks, may be superior to electronic measurements when
      assessing patients for deterioration. Currently, there are no guidelines to recommend what
      form of monitoring, continuous monitoring or scheduled vital checks, is superior and studies
      evaluating the rationale behind widespread continuous monitoring techniques are lacking.

      This study will determine if there is a difference in hospital length of stay between
      pediatric patients admitted for uncomplicated respiratory illnesses receiving continuous
      hardwire cardiorespiratory monitoring and those receiving intermittent vital signs
      measurements. Patients will be randomized to two groups. One group will be comprised of
      patients receiving continuous hardwire monitoring during the entire stay in the hospital. The
      other group will be comprised of patients receiving intermittent vital signs measurements
      (heart rate, respiratory rate, blood pressure, oxygen saturation, and temperature) every four
      hours, per standard of care on the pediatric unit.

      Data will be collected on supplemental oxygen use and patients' level of oxygen saturation
      throughout the hospital stay. On day of hospital discharge, up to 14 days, parents or
      guardians will be asked to complete the Parent Study Questionnaire, to assess parental rating
      of the level of care their child received in hospitalization and parental comfort level with
      continuing to care for their child at home.
    

Intervention name(s): Continous Pulse oximeter; Intermittent Pulse oximeter
Intervention type(s): Device; Device
Intervention description(s): Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization; Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Prospective, single-site
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulse oximetry; Oxygen saturation; Hypoxia; Blood oxygen level