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. 2017 Jul 13;2017(7):CD004104. doi: 10.1002/14651858.CD004104.pub4

Avdeev 1998.

Methods Country: Russia
Design: Randomised controlled parallel trial. Participants were matched for demographic and physiological norm values
Study site: One hospital in Moscow, conducted between September 1995 and March 1997
Method of analysis: Unclear
Aim: To determine the effect of NIV on need for endotracheal intubation, mortality rate, length of hospital stay, and incidence of complications in patients with acute respiratory failure caused by AECOPD
Participants Eligible for study: Not stated
Recruited: 58 adult patients with acute respiratory failure due to AECOPD (29 in each group)
Completed: Not stated
Age: NIV group: mean (SD) age = 63.4 (5.5) years; usual care group: mean (SD) age = 66.2 (7.1) years
Gender: NIV group (M:F) = 26:3, usual care group (M:F) = 22:7
Criteria used to define COPD: Not stated
Inclusion criteria: Insufficient information available
Exclusion criteria: Insufficient information available
Interventions Intervention description: NIV plus usual care. BiPAP ventilators (Respironics, Inc., Murrysville, PA, USA) used with inspiratory pressure titrated to 30 cmH2O and expiratory pressure of 4 to 6 cmH2O. Both face masks and nasal masks were used
Control description: Oxygen, bronchodilators, steroids, and theophylline
Duration of intervention: Mean (SD) duration of NIV was 29 (25) hours
Intervention delivery by: Insufficient information available
Setting: Intermediate care unit
Outcomes Method of outcome data collection: Not clear
Prespecified primary outcomes: Not clear which outcomes deemed primary. Specified outcomes were need for intubation, mortality rate, length of hospital stay, and incidence of complications. No clinical trial registry to confirm
Prespecified secondary outcomes: Other outcomes reported included breathlessness score (Borg) and ABGs
Follow‐up period: Data collected until hospital discharge
Notes Trial was published in Russian
Study author was contacted and provided additional information
Funder: Unclear
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Described as randomised; other information not available
Allocation concealment (selection bias) Low risk Sealed opaque envelopes were used for treatment allocation.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Owing to nature of the intervention, blinding was not possible. No sham NIV used; however, unlikely to have affected primary outcomes. May have affected subjective ratings of dyspnoea
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Unsure whether investigators were involved in participant treatment
Incomplete outcome data (attrition bias) 
 All outcomes High risk 3 participants from the NIV group were excluded owing to NIV intolerance. Insufficient information available to determine reasons or potential impact
Selective reporting (reporting bias) Low risk No evidence of selective reporting
Imbalance of outcome measures at baseline 
 All outcomes Unclear risk Insufficient information available
Comparability of intervention and control group characteristics at baseline Unclear risk Participants in the NIV group had lower age at baseline. Unclear whether statistically significant. Insufficient information available for other outcomes
Protection against contamination 
 All outcomes Unclear risk Insufficient information available
Selective recruitment of participants Low risk N‐values and methods of recruitment were similar
Other bias Low risk No other sources of bias identified