Heliox therapy in bronchiolitis: phase III multicenter double-blind randomized controlled trial.
Pediatrics
; 131(4): 661-9, 2013 Apr.
Article
em En
| MEDLINE
| ID: mdl-23509160
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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Oxigênio
/
Terapia Respiratória
/
Bronquiolite
/
Hélio
/
Nitrogênio
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Limite:
Female
/
Humans
/
Infant
/
Male
Idioma:
En
Revista:
Pediatrics
Ano de publicação:
2013
Tipo de documento:
Article
País de afiliação:
Reino Unido