Suctioning of NOse Therapy in Bronchiolitis
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional

Summary: 
      Research Questions:

      Primary:

      In otherwise healthy infants 4 weeks to 12 months of age discharged home from the ED with
      acute bronchiolitis,1 is there a difference in the probability of "treatment failure" by 72
      hours post discharge from the index ED visit in those receiving nasal suctioning via Zo-Li
      device prior to feeds compared to infants who receive nasal suctioning via bulb? Treatment
      failure is defined as 1) any bronchiolitis-related healthcare visit, except visits that have
      occurred only due to ED-recommendation at time of ED discharge or 2) the use of additional
      (non-study assigned) suctioning devices (see Outcome Measures section) within approximately
      72 hours post discharge at the index ED visit.

      Hypothesis:

      We hypothesize that the infants who undergo scheduled nasal suctioning via ZoLi device will
      experience a lower treatment failure probability by approximately 72 hours post discharge
      from index ED visit compared to those managed by suction via a bulb.

      Secondary:

        1. In these infants, is there a difference in the mean number of medical visits for
           bronchiolitis (defined as #1 under primary outcome above) within 72 hours of ED
           discharge?

        2. In these infants, is there a difference in the mean number of unscheduled medical visits
           for bronchiolitis within 72 hours of ED discharge?

        3. In these infants, is there a difference in the mean number of ED visits for
           bronchiolitis within 72 hours of ED discharge?

        4. In these infants, is there a difference in the probability of a parent reporting
           normal/near normal feeds on approximately 72 hours discharge?

        5. In these infants, is there a difference in the probability of a parent reporting
           normal/near normal sleeping on approximately 72 hours post ED discharge?

        6. For the parent, is there a difference in the probability of a parent reporting their own
           normal/near normal sleeping on approximately 72 hours post ED discharge?

        7. In these infants, is there a difference in the probability of parents reporting at 72
           hours post ED discharge as being "very satisfied" or "satisfied" with their ability to
           care for their child during the study period?

      The sample size calculation is based on the assessment of the between-group difference in
      probability of treatment failure. The estimated total re-visit probability in bronchiolitis
      based on a recently published study was approximately 35% within 72 hours of ED discharge.49
      In our pilot we have found the same rate of treatment failure. This is a superiority study in
      which the adoption of nasal suctioning will be recommended for future practice if the
      observed proportion of the primary outcome in this group is significantly lower than in the
      controls. With 162 patients per arm (324 in total) a two-sided test with a type I error of
      0.05 will have 80% power to achieve statistical significance if suctioning reduces the
      probability of treatment failure from 40% to 25% (i.e. absolute reduction of 15%). This
      estimate is based on clinically relevant differences agreed upon by study investigators and
      it also represents an NNT of 7. In the Cochrane review of asthma therapies an NNT of a
      comparable magnitude led to a change in national practice recommendations.51 Since
      bronchiolitis and related medical visits are highly prevalent,20 this target difference would
      also have an important economic impact. Based on our previous bronchiolitis trials, the
      anticipated refusal rate may be 20%. Given the study design and our past experience, the
      study non-completion rate and loss to follow-up can safely be assumed to be no higher than 5%
      each. Therefore, to have complete data on 324 patients we plan to randomize 360 (i.e. 324/ (1
      - 0.05) *(1 - 0.05) and to approach 450 (i.e. 360/ (1 - 0.20).
    

Detailed description: 
      This is a multi-center, randomized, outcome assessor- blinded clinical trial of infants
      discharged home from the ED with acute bronchiolitis. Two groups will be compared: infants
      receiving bronchiolitis suctioning via a bulb (see below) versus those given nasal suctioning
      via a battery-operated nasal aspiration Zo-Li device just prior to each feeding for 72 hours
      post index ED visit discharge. Evidence suggests that suctioning at frequent intervals is
      associated with movement of secretions from the lower airway with improved minute volume.40
      The 72 hour study period has been chosen since the majority of infants discharged from the ED
      with bronchiolitis experience the targeted outcomes within this time frame.9

      Prior to the ED discharge, all study participants will receive usual bronchiolitis care
      ordered by the ED physician as per standard of care which consists of supplemental oxygen for
      saturations <90% and supplemental IV hydration in those with inadequate oral intake.41
      Eligible consenting patients deemed suitable for discharge home (representing approximately
      60-70% of the bronchiolitis population presenting to the ED) will be randomly allocated to
      one of two study groups:

      Control Group: this group will receive standardized routine discharge instructions describing
      information about bronchiolitis, expected course of illness, recommended management
      strategies such as fever control, augmented air humidification, need for frequent feeding and
      warning signs prompting return for care. This group will be suctioned prior to feeds via bulb
      suction (with saline drops) which is expected to provide minimal effect, due to non-sustained
      negative pressures generated during bulb release. Since the benefit of nasal suction in
      bronchiolitis is unknown, this design is ethically reasonable. However, the use of no suction
      would likely meet with parental resistance and enrollment would be difficult. Families in the
      control group will be given the bulb device at no cost and instructed in the appropriate
      technique of using this tool prior to feeds.

      Intervention Group: in addition to receiving the aforementioned bronchiolitis discharge
      instructions, this group will undergo nasal suctioning prior to each feeding as needed for 72
      hours post discharge home, using exclusively the Zo-Li study device (see above under study
      device), with saline nose drops. Families in this group will be given the Zo-Li device at no
      cost and instructed in the appropriate technique and importance of using this tool.

      We shall not reveal the identity of the study devices to the ED physicians in order to
      minimize contamination of the control group. The ED treating physicians will also be blinded
      to which device the infant had been randomized to. We shall also ask the ED treating
      physicians not to recommend specific suctioning devices to the study patients.
    

Intervention name(s): Battery operated nasal aspirator; Suction bulb
Intervention type(s): Device; Device
Intervention description(s): Suctioning prior to every feed with battery operated nasal aspirator for three days in addition to the routine standard of care.; Suctioning prior to every feed with bulb nasal aspirator for three days in addition to the routine standard of care.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective interventional.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nose suctioning; Pediatric