CTRI/2018/09/015717.

Study name	High‐flow oxygen through nasal cannula in acute hypoxemic respiratory failure
Methods	RCT, parallel‐group design
Participants	Estimated number of participants: 140 Setting: ICU, India Inclusion criteria: age ≥ 18; respiratory rate > 25 breaths/min; PaO2/FiO2 ≤ 300 whilst breathing 10 L/min O2 for 15 mins Exclusion criteria: PaCO2 > 45 mmHg, exacerbation of asthma or chronic respiratory failure; cardiogenic pulmonary oedema; history of chronic respiratory disease; haemodynamic instability; GCS ≤ 12, contraindications to NIV, urgent need for intubation; palliative patients; tracheostomy; moribund < 72 hrs, respiratory failure due to potentially irreversible causes
Interventions	Intervention group (HFNC): flow = 60 L/min, Fisher & Paykel Control group 1 (standard oxygen therapy): flow ≥ 10 L/min non‐rebreathe facemask Control group 2 (NIV): via facemask (Teleflex/Hudson)
Outcomes	All outcomes measured: intubation rate within 28 days; number of ventilator‐free days; ICU mortality rate; intubation rate with PaO2/FiO2 < 200; intubation rate in neutropenic participants; total duration of ICU stays; complication rate; dyspnoea Outcomes relevant to this review: intubation rate within 28 days; ICU mortality rate; total duration of ICU stays; complication rate; dyspnoea
Starting date	14 September 2018
Contact information	Dr Sheila Nainan Myatra, sheila150@hotmail.com
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