Heliox therapy in bronchiolitis: phase III multicenter double-blind randomized controlled trial.

Abstract:

BACKGROUND AND OBJECTIVE:Supportive care remains the mainstay of therapy in bronchiolitis. Earlier studies suggest that helium-oxygen therapy may be beneficial, but evidence is limited. We aimed to compare efficacy of 2 treatment gases, Heliox and Airox (21% oxygen + 79% helium or nitrogen, respectively), on length of hospital treatment for bronchiolitis. METHODS:This was a multicenter randomized blinded controlled trial of 319 bronchiolitic infant subjects randomly assigned to either gas; 281 subjects completed the study (140 Heliox, 141 Airox), whose data was analyzed. Treatment was delivered via facemask (nasal cannula, if the facemask intolerant) ± continuous positive airway pressure (CPAP). Severe bronchiolitics received CPAP from the start. Primary end point was length of treatment (LoT) required to alleviate hypoxia and respiratory distress. Secondary end-points were proportion of subjects needing CPAP; CPAP (LoT); and change in respiratory distress score. RESULTS:Analysis by intention to treat (all subjects); median LoT (inter-quartile range, days): Heliox 1.90 (1.08-3.17), Airox 1.87 (1.11-3.34), P = .41. Facemask tolerant subgroup: Heliox 1.46 (0.85-1.95), Airox 2.01 (0.93-2.86), P = .03. Nasal cannula subgroup: Heliox 2.51 (1.21-4.32), Airox 2.81 (1.45-4.78), P = .53. Subgroup started on CPAP: Heliox 1.55 (1.38-2.01), Airox 2.26 (1.84-2.73), P = .02. Proportion of subjects needing CPAP: Heliox 17%, Airox 19%, O.R. 0.87 (0.47-1.60), P = .76. Heliox reduced respiratory distress score after 8 hours (mixed models estimate, -0.1298; P < .001). The effect was greater for facemask compared with nasal cannula (mixed models estimate, 0.093; P = .04). CONCLUSIONS:Heliox therapy does not reduce LoT unless given via a tight-fitting facemask or CPAP. Nasal cannula heliox therapy is ineffective.

journal_name

Pediatrics

journal_title

Pediatrics

authors

Chowdhury MM,McKenzie SA,Pearson CC,Carr S,Pao C,Shah AR,Reus E,Eliahoo J,Gordon F,Bland H,Habibi P

doi

10.1542/peds.2012-1317

subject

Has Abstract

pub_date

2013-04-01 00:00:00

pages

661-9

issue

4

eissn

0031-4005

issn

1098-4275

pii

peds.2012-1317

journal_volume

131

pub_type

杂志文章,多中心研究,随机对照试验
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