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

Vargas 2015.

Study characteristics
Methods RCT, cross‐over design. Single‐centre study
Participants Total number of randomized participants: 12
Setting: ICU; France
Inclusion criteria: people with AHRF
Exclusion criteria: people with tracheostomies; < 18 years of age; chronic retention of CO2; respiratory acidosis; factors related to insertion of an oesophageal catheter; excessive amounts of respiratory secretions; SBP < 90 mmHg; ventricular arrhythmia; encephalopathy or coma; life‐threatening hypoxaemia; decision to limit life‐support treatments in the ICU
Baseline characteristics (overall):
  • Age, median (IQR): 63 (59 to 73) years

  • Gender, M/F: 10/2

  • BMI, mean (SD): not reported

  • SAPS II, median (IQR): 48 (35 to 56)

  • PaCO2: not reported

  • PaO2/FiO2, median (IQR): 178 (157 to 199) mmHg

Interventions Cross‐over study with each period lasting approximately 20 minutes. All participants were first given conventional oxygen therapy using a non‐rebreather face mask; participants were not randomized to this group.
Intervention group (HFNC):
  • Randomized, n = 12; losses, n = 0; analysed, n = 12

  • Details: HFNC via Optiflow, with largest cannula tolerated by the individual participants, gas flow set at 60 L/min, temperature set at 37 °C


Control group (NIV: BiPAP):
  • Randomized, n = 12; losses, n = 0; analysed, n = 12

  • Details: BiPAP fitted to a face mask. CPAP set at 5 cm H2O

Outcomes Oesophageal pressure; blood gas analysis and haemodynamic variables; comfort and dyspnoea
Note: we did not include outcome data in the review because the study authors did not report outcome data from the first study period.
Notes Funding/declarations of interest: supported by a research grant from Fisher & Paykel Healthcare Ltd
Study dates: January 2011 to January 2012