Monitoring OXYgen in Infants Hospitalized With Bronchiolitis: A Best Practices Trial (The MOXY Trial)
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In infants hospitalized with bronchiolitis, a common infection in the lungs caused by a
      virus, it is uncertain on how to best monitor their oxygen levels. It is common to place a
      probe on infants hands or legs to monitor oxygen levels. The probe can be used to monitor
      oxygen levels all the time (continuous oxygen monitoring) or just every 4-6 hours
      (intermittent oxygen monitoring). There is reason to believe that placing children with
      bronchiolitis on continuous monitoring might result in children staying longer in hospital
      than needed. This is a research study that is aiming to provide data to plan a larger
      research study to answer the question of whether intermittent oxygen monitoring is better
      than continuous oxygen monitoring. This study is part of a larger initiative to determine the
      best way to care for children with bronchiolitis, including making sure that children do not
      stay in hospital longer than needed.

      Parents will be asked to participate in this research study if their child is hospitalized
      with bronchiolitis and has been stable for at least 6 hours, meaning that he/she is not
      having more trouble breathing or does not require more supplemental oxygen. If they agree
      participate, the child will have one of the two oxygen monitoring strategies: intermittent or
      continuous monitoring. Each child will have an equal chance of getting one or the other of
      these two monitoring strategies.

      The study team will review the children's charts to determine the number of tests ordered,
      the need for intensive care unit help or admissions, the number of blood tests and chest
      x-rays the treating doctors ordered, and the length of hospital stay. Parents will be
      contacted about 4-5 days after discharge to ask if there were any unscheduled visits to
      doctors or emergency rooms after discharge. The investigators will the parents to fill out a
      scale twice a day asking how well their child is feeding. The investigators will also them to
      rate their anxiety level once a day.

      The information from this study will help plan and support an application for external
      funding. The results of a larger study could potentially decrease unnecessary monitoring,
      oxygen supplementation, and hospital stay and thereby improve quality of care with large cost
      savings. A reduction in length of hospital stay for this common hospital condition would also
      reduce the burden of hospitalization to families and reduce the risks associated with harm in
      the hospital setting such as infection and medical error.
    


Intervention name(s): Intermittent oxygen monitoring; Continuous oxygen monitoring
Intervention type(s): Procedure; Procedure
Intervention description(s): Oxygen saturation and vital signs will be measured intermittently at a frequency of every 4 hours by the bedside nurse through the child's hospital stay until discharge. The nurse will attach the probe to the electrical cord which is connected to the monitor. For each measurement, the duration of monitoring will be until a steady wave form is present on the oxygen saturation monitor, indicating a reliable measurement (consistent with current standard of practice). The nurse will document the maximum and minimum reading during the period. The nurse will detach the probe from the electrical cord, leaving the probe attached to the child. Hence, the child's probe will be attached to the electrical cord intermittently as well.; Oxygen saturation will be measured continuously through the child's hospital stay until discharge. Every 4 hours the nurse will complete and document a set of vital sign measurements, including oxygen saturation level, in keeping with current clinical practice. The reading will be displayed on the bedside monitor in the participants' room. At the completion of vital signs measurement, the nurse will not detach the electrical cord from the probe. Hence, the child's probe will be attached to the electrical cord continuously as well.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Bronchiolitis; Length of stay; Pilot Projects; Oxygen saturation monitoring