Hu 2020.
Study characteristics | ||
Methods | RCT, parallel‐group design. Single‐centre study | |
Participants |
Total number of randomized participants: 56 Setting: medical ICU; Taiwan Inclusion criteria: adults admitted to the ICU with acute respiratory failure and mechanically ventilated for > 48 hours, successfully passed a SBT; meeting at least one risk factor for high‐risk extubation failure Exclusion criteria: < 20 years of age; tracheostomy; pregnancy; facial trauma with intolerable post‐extubation facial mask or HFNC use; acute gastrointestinal bleeding; planning to use NIV after extubation Baseline characteristics: Intervention group (HFNC):
Control group (conventional oxygen therapy):
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Interventions | Intervention group:
Control group:
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Outcomes | Respiratory failure within 72 hours (requiring rescue management with oxygen therapy, NIV, or reintubation); time to post‐extubation failure within 72 hours; multiple organ failure; ICU length of stay; 28‐day all‐cause mortality (in‐hospital); 48‐hour respiratory and haemodynamic variables (heart rate, MAP, PaO2, PaCO2); causes of respiratory failure (dyspnoea or hypoxia, respiratory acidosis, decreased levels of consciousness, stridor or upper airway problems) | |
Notes |
Funding/declarations of interest: funding not reported. Study authors declared no competing interests. Study dates: September 2014 to December 2016 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | 1:1 block randomization used |
Allocation concealment (selection bias) | Unclear risk | No details |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding was not possible and we did not expect it to influence outcome data. However, the influence on RoB remains unclear. |
Blinding of outcome assessors (objective outcomes) | Low risk | Blinding of outcome assessors. Although we expected that this would not influence outcome data, we could not be certain of this. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No participant losses |
Selective reporting (reporting bias) | High risk | Study was prospectively registered with a clinical trials register (NCT 02290548). Whilst most review outcomes were reported according to these trial register documents, we noted that study authors did not report data for hospital length of stay and for pneumonia; this may indicate selective reporting bias for these outcomes. |
Other bias | Low risk | We identified no other sources of bias. |