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 |
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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 |
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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 |
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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 |
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Notes |
Declarations of interest: none reported Funding sources for the study: none reported |
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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 |