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. 2015 Oct 5;2015(10):CD009134. doi: 10.1002/14651858.CD009134.pub2

Gao 2002.

Methods Randomization procedure: concealed randomization
Allocation: not reported
Blinding: not reported
Design: randomized, controlled
Duration: not reported
Multicentre: no
Analysis (ITT): not reported
Informed consent: not reported
Participants Number of participants: 60
Setting: ICU
Age (mean ± SD): O: 64 ± 8.1 years; NPPV: 65 ± 10.4 years
Gender (M/W): O: 21/9; NPPV: 23/7
Diagnostic criteria: elderly participants with respiratory rate over 30 breaths/minute after upper abdominal surgery in an ICU
Exclusion criteria: indication of endotracheal intubation PaO2 ≤ 60 mm Hg or PaCO2 ≥ 50 mm Hg under oxygen mask or NPPV with oxygen flow rate of 5 L/min
Number excluded: not reported
Interventions Control: routine oxygen mask with oxygen flow rate of 5 L/min
Intervention: NPPV. Assisted mechanical ventilation using an oxygen mask. The ventilator was Evita 4, PSV pattern was used, with the flow trigger 3 L/min and FiO2 40%. The PSV levels were adjusted from 10 cm H2O until VT > 7 mL/kg or respiratory rate < 25 breaths/min. PEEP was set at 3‐5 cm H2O
Number of participants per group: O: 30; NPPV: 30
Mask: appropriate facial mask was adopted that allowed the stomach tube to pass through
Outcomes Primary outcome: endotracheal intubation
Secondary outcome: ICU and hospital length of stay; incidence of pneumonia, infection, and sepsis within the first month after surgery; and hospital mortality. Pneumonia, infection, and sepsis were identified using standard definitions
Mortality: not reported
Tracheal intubation rate: O: 8 NPPV: 3
ICU length of stay: O: 7 ± 5 days; NPPV: 4 ± 3 days
Hospital length of stay: not reported
Treatment failure: not reported
Adverse effects: not reported
Participant compliance: not reported
Drop‐outs/withdrawals: not reported
Notes Declarations of interest: none reported
Funding sources for the study: none reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The method used was not reported. We wrote to the contact author asking about this procedure but did not receive an answer
Allocation concealment (selection bias) Unclear risk The method used was not reported. We wrote to the contact author asking about this procedure but did not receive an answer
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not reported. We contacted the authors of this study to ask about blinding of study participants and personnel but did not obtain an answer
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported. We contacted the authors of this study to ask about blinding of study outcome assessors but did not obtain an answer
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No missing outcome data
Selective reporting (reporting bias) Low risk The study protocol was available and all of the study's pre‐specified (primary and secondary) outcomes that are of interest in the review were reported in the pre‐specified way
Other bias Low risk This study was not a cluster randomized or a cross‐over trial. This study was a randomized controlled trial. The participants were randomized. The distribution of the participants was balanced between the control and intervention groups. The authors did not deviate from the study protocol