Hollmann 1998.
Methods | Randomised, double‐blind, controlled, cross‐over study | |
Participants | 13 infants (3 weeks to 23 months old) admitted to the PICU with RSV bronchiolitis RSV+, FiO2 < 50%, Criteria for inclusion: Bronchiolitis RSV+, with signs of lower respiratory tract disease Baseline characteristics, median (range): Age, mo 2.5 (3 wks to 24 mos) Clinical Asthma Score (m‐WCAS, maximum score of 10): 3.04 (1 to 7.5). | |
Interventions | Inhalation in a random order of heliox AND air‐oxygen, by non‐rebreather standard reservoir mask for two 20‐minute study periods | |
Outcomes | Primary endpoint: Clinical Asthma Score at 20 min Secondary endpoints: respiratory rate, heart rate and SpO2 | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Coin tossing |
Allocation concealment (selection bias) | Low risk | |
Blinding (performance bias and detection bias) All outcomes | Low risk | 1 investigator was not blinded: the respiratory therapists; blinding was maintained by covering the on‐off valves to the air and helium sources with tape |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All patients completed the study and there were no losses to follow‐up, no treatment withdrawals 21 eligible patients were admitted during the study period. 3 patients were excluded from the study because of technical difficulties in setting up the gas delivery system (n = 1) and because of marked agitation (n = 2). 1 of the patients with agitation was intubated shortly after admission to the ICU. A total of 18 patients were studied, 13 of whom were randomised. Of the 13 randomised patients, 12 patients had Clinical Asthma Scores of < 6 and 1 patient had a Clinical Asthma Score of 7.5 but only mild signs of expiratory obstruction |
Selective reporting (reporting bias) | Low risk | All results for outcomes were reported |
Other bias | Low risk |