Transcript Journal Club slides

JAMA Pediatrics Journal Club Slides:
Nebulized Hypertonic Saline for Bronchiolitis
Florin TA, Shaw KN, Kittick M, Yakscoe S, Zorc JJ. Nebulized
hypertonic saline for bronchiolitis in the emergency department: a
randomized clinical trial. JAMA Pediatr. Published online May 26,
2014. doi:10.1001/jamapediatrics.2013.5306.
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Introduction
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Background
– Acute bronchiolitis is the most frequent lower respiratory infection and
most frequent cause for hospitalization in infants.
– There are no proven effective therapies for bronchiolitis; nebulized
hypertonic saline (HS) has been proposed as a potential therapy.
– HS is thought to increase mucociliary clearance by lowering the
viscosity of mucus secretions, stimulating cilial beat, and reducing
airway edema.
– There is conflicting evidence about the role of HS for the treatment of
acute bronchiolitis.
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Study Objective
– To determine whether nebulized 3% HS compared with normal saline
(NS) improves respiratory distress in infants with bronchiolitis not
responding to a trial of nasal suctioning and nebulized albuterol sulfate
in the emergency department (ED).
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Methods
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Study Design
– Randomized clinical trial with blinding of investigators, health care
providers, and parents.
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Setting
– A single urban tertiary care pediatric ED during 2 bronchiolitis seasons,
from November 1 to April 30 of 2010 and 2011.
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Patients
– Inclusion: (1) Aged 2 to <24 months, (2) first episode of bronchiolitis
(wheezing with signs and symptoms of respiratory distress and upper
respiratory infection), (3) Respiratory Distress Assessment Instrument
(RDAI) score of 4-15 after albuterol treatment.
– Exclusion: (1) History of wheezing or asthma, or bronchodilator therapy
before current illness, (2) chronic lung or heart disease, (3) critical
illness, (4) inability to receive nebulized medications, (5) non–Englishspeaking guardians.
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Methods
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Interventions
– 4 mL of 3% HS vs 4 mL of NS.
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Outcomes
– Primary: Respiratory Assessment Change Score (RACS) at 1 hour after
study intervention (RACS = change in RDAI score + standardized change
in respiratory rate; decrease in RACS signifies clinical improvement).
– Secondary: Vital signs, oxygen saturation, hospitalization, physician
clinical impression, parental perception of improvement, adverse events.
Respiratory Distress Assessment Instrument
(adapted from Lowell et al22)
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Results
Consolidated Standards for Reporting of Trials Study Flow Diagram
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Results
Baseline Characteristics
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Results
RACS Values 1 Hour After HS and NS Administration
Using a RACS of −3 as a clinically significant improvement, the NS
group demonstrated improvement in respiratory status 1 hour after
treatment, and the HS group did not substantially improve.
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Results
Outcomes 1 Hour After Saline Administration
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Difference in RACS at 1
hour after treatment
demonstrated
significantly less
improvement in HS group
compared with NS group.
No significant difference
in RDAI score.
Greater decrease in
respiratory rate from
baseline to 1 hour in NS
group compared with HS
group.
No significant differences
in secondary outcomes.
Results
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No significant difference in RACS at 2 hours after study intervention
between the 2 groups.
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During patient follow-up, there were no significant differences between the
HS and NS groups in:
– Parental perception of study treatment improving their child’s symptoms.
– Unscheduled pediatrician visits.
– Hospitalization after initially being discharged from the ED.
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No adverse events occurred during the study.
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Comment
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This randomized clinical trial demonstrated that infants with bronchiolitis
with persistent distress after nasal suctioning and a trial of albuterol who
received a single dose of nebulized 3% HS in the ED had less improvement
in respiratory distress compared with those receiving NS.
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Lack of benefit of HS compared with NS in the ED is consistent with findings
of prior studies.
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These results are in contrast to those of studies examining the use of HS
repeatedly over time, which generally show a decreased length of stay in
hospitalized infants or improved clinical severity in outpatients.
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Comment
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Limitations
– Single-center study—results may not be generalizable.
– Single dose of 3% HS—relatively low concentration of HS. Results may differ with
increasing concentrations or repeated doses.
– Intended to separate delivery of albuterol and HS, so primary outcome was
measured after peak effect of albuterol; however, it is possible there were residual
effects of albuterol at time of assessment.
– RACS as short-term outcome; however, ED and primary care providers make
disposition and treatment decisions based on short-term outcomes, making this a
relevant choice given the practice environment.
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Conclusions
– HS results in less improvement 1 hour after treatment in the ED compared with NS in
infants with bronchiolitis who had persistent distress after albuterol and nasal
suctioning.
– Administration of a single dose of HS in the acute care setting does not appear to be
more effective than NS in improving short-term respiratory distress in bronchiolitis.
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Contact Information
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If you have questions, please contact the corresponding author:
– Todd A. Florin, MD, MSCE, Division of Pediatric Emergency
Medicine, Cincinnati Children’s Hospital Medical Center, 3333 Burnet
Ave, ML 2008, Cincinnati, OH 45229 ([email protected]).
Funding/Support
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This study was supported by a Young Investigator Award from the
Academic Pediatric Association.
Conflict of Interest Disclosures
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None reported.
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