7% Hypertonic Saline for Acute Bronchiolitis
Condition: Acute Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Research suggests that hypertonic saline may improve mucous flow in infants with acute
      bronchiolitis. Data suggest a trend favoring reduced length of hospital stay and improved
      pulmonary scores with increasing concentration of nebulized solution to 3% and 5% saline as
      compared to 0.9% saline mixed with epinephrine. To our knowledge, 7% hypertonic saline has
      not been previously investigated. OUr hypothesis was that 7% hypertonic saline would improve
      bronchiolitis severity scores and admission rate.
    

Detailed description: 
      Study design A double-blinded, randomized, comparative, controlled trial was conducted in the
      ED of an urban tertiary care center, with an annual census of 70,000 patient visits. The
      Institutional Review Board approved the study.

      Patient selection Informed consent was obtained from a parent or legal guardian of each
      patient enrolled in the study. Patients age 6 weeks to ≤ 18 months presenting to the ED
      between October and March over a 2-year period (2010-2012) with bronchiolitis (defined as
      viral respiratory illness and first episode of wheeze) and a BSS score of ≥ 4 were eligible
      for the study. Exclusion criteria were a previous history of wheezing; diagnosis of asthma;
      any use of bronchodilators within 2 h of presentation; gestational age ≤ 34 weeks; history of
      congenital heart disease, chronic pulmonary or chronic renal disease; oxygen saturation of ≤
      85% at the time of recruitment; severe disease requiring intensive care unit admission, or
      inability to obtain informed consent. Depending on the availability of the principal
      investigator (a pediatric emergency medicine fellow), a convenience sample was used to
      recruit patients. The ED physicians and staff were notified of the fellow's hours of
      availability by way of a call schedule that was posted in the ED.

      Study protocol Eligible patients were randomized to one of two groups in blocks of 10. The
      control group received an aerosol of 0.5 ml of 2.25% racemic epinephrine with 3 ml of 0.9%
      saline, and the study group received 0.5 ml of 2.25% racemic epinephrine with 3 ml of 7% HS.

      The treating clinician in the ED contacted the principal investigator within an hour of an
      eligible patient's arrival. The pharmacy department maintained a box in the ED holding
      sequentially numbered, previously randomized concealed envelopes containing either the study
      (7% HS) or control (0.9% saline) medication. After initial screening and assessment and after
      consent was obtained, the patient was administered the medication via nebulization driven by
      6 L/min O2 flow. Research personnel, the treating physician, and staff who performed the BSS
      were kept blinded throughout the process. Bronchiolitis severity scores were recorded prior
      to administering aerosols, after administering the aerosol, and again once the treating
      clinician determined the final disposition of the patient.

      After a 4-h observation period, the treating clinician determined patient disposition. If
      admitted, the patient continued to receive aerosols containing the same designated medication
      every 6 h until discharge or 24 h after the admission. Bronchiolitis severity scores were
      obtained before and after each treatment. A standardized data sheet was completed after
      enrollment and during each patient's stay in the ED or inpatient ward. Any co-interventions
      such as additional bronchodilators, supplemental oxygen, intravenous fluids, or deep nasal
      suction were at the discretion of the treating clinician. The clinician was free to withdraw
      the patient from the study if clinical deterioration warranted escalation of care or if
      adverse effects related to the medication were observed.

      Outcome measures The BSS is an objective respiratory assessment tool that has been previously
      validated (Table 1).14 We used a modified BSS, which is used in our institution since 2006,
      to assess severity of illness in acute bronchiolitis. (Table 2) A change in the modified BSS
      was the primary outcome.
    

Intervention name(s): Hypertonic saline and epinephrine; Normal saline and epinephrine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment