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. 2021 Mar 4;2021(3):CD010172. doi: 10.1002/14651858.CD010172.pub3

Shebl 2018.

Study characteristics
Methods RCT, parallel‐group design. Single‐centre study
Participants Total number of randomized participants: 70
Setting: ICU; Saudi Arabia
Inclusion criteria: adults with interstitial lung diseases and acute respiratory failure; with PaO2/FiO2 ≤ 300 mmHg despite oxygen supplementation at a flow rate ≥ 10 L/min for at least 15 minutes or manifestation of increased work of breathing
Exclusion criteria: < 18 years of age; pneumothorax, absolute indication for urgent intubation like coma; contraindication to NIV
Baseline characteristics:
Intervention group (HFNC):

  • Age, mean (SD): 61.3 (± 13) years

  • Gender, M/F: 11/23

  • BMI, mean (SD): 22.9 (± 4.1) kg/m2

  • APACHE II, mean (SD): 14.9 (± 4.12)

  • PaCO2, mean (SD): 38.8 (± 3.4) mmHg

  • PaO2/FiO2, mean (SD): 178 (± 55) mmHg


Control group (NIV):

  • Age, mean (SD): 60.95 (± 12) years

  • Gender, M/F: 14/22

  • BMI, mean (SD): 24.3 (± 3.7) kg/m2

  • APACHE II, mean (SD): 15.2 (± 3.9)

  • PaCO2, mean (SD): 39.1 (± 2.6) mmHg

  • PaO2/FiO2, mean (SD): 166 (± 42) mmHg
Interventions Intervention group (HFNC):

  • Randomized, n = 34; losses, n = 0; analysed, n = 34

  • Details: oxygen delivered via Optiflow, using a large‐diameter nasal cannula. Therapy until the participant recovered or was intubated


Control group (NIV):

  • Randomized, n = 36; losses, n = 0; analysed, n = 36

  • Details: NIV using BiPAP Vision. Continuous positive airway pressure mode initiated for NIV, gradually incremented to 12 cm H2O. Pressure support for respiratory acidosis of if respiratory rate > 30 breaths/min. FiO2 adjusted at lowest level to maintain PaO2 > 60 mmHg
Outcomes Intubation within 28 days; ICU mortality; number of days without need for invasive MV within 28 days
Notes Funding/declarations of interest: no funding. Study authors declared no conflicts of interest.
Study dates: January 2016 to May 2017
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Described as randomized, but no additional details
Allocation concealment (selection bias) Unclear risk No details
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Blinding was not possible. Although we expected that this would not influence outcome data, we could not be certain of this.
Blinding of outcome assessors (objective outcomes) Low risk Blinding of outcome assessors was not described; we did not anticipate that this would influence the assessment of objective outcome measures.
Incomplete outcome data (attrition bias)
All outcomes Low risk No losses
Selective reporting (reporting bias) Unclear risk Study authors did not report clinical trials registration or prepublished protocol. It was not feasible to effectively assess risk of selective reporting bias without these documents.
Other bias Low risk We identified no other sources of bias.