Original ArticleNoninvasive Therapy with Helium–Oxygen for Severe Bronchiolitis
Section snippets
Study Design
This was a concealed, randomized trial with blinding of patients, their parents, all caregivers except for respiratory therapists, and data collectors. After parental consent, infants were randomly assigned to receive a helium–oxygen mixture (helium group) or an air–oxygen mixture (control group) through an inflatable head hood. This research project was approved by the institutional review boards of all participating hospitals.
Study Population
All infants under age 9 months and weighing < 10 kg who were
Patient Characteristics
From October 2000 to May 2003, 157 infants were screened for inclusion, and 39 met eligibility criteria. Reasons for nonenrollment included intubation and institution of mechanical ventilation before PICU entry (83), age > 9 months or weight > 10 kg (16), negative RSV test (10), PICU stay > 8 hours (8), uncorrected cyanotic heart disease or cardiac failure (8), unavailable equipment (6), history of a previous bronchiolitis episode (5), parental refusal of consent (4), bronchopulmonary dysplasia
Discussion
This study did not detect any differences between the patients in the helium group and the control group with respect to the rate of positive-pressure ventilation (invasive or noninvasive), the evolution of clinical signs and symptoms, or the duration of the study gas administration. The rate of endotracheal intubation observed in our study population (8/39; 21%) was far below that observed previously (58%) and could not be attributed to a lesser gravity of illness, as suggested by the fact
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Supported by Air Liquide Santé International, France, and by the Fonds de la Recherche en Santé du Québec (FRSQ), Québec, Canada.