NCT04269681.

Study name	Renovate palliative study: randomized controlled trial comparing high‐flow nasal catheter versus standard respiratory support in patients with do‐not‐intubate order and acute respiratory failure
Methods	RCT, parallel‐group design. Multicentre study
Participants	Estimated number of participants: 150 Setting: ICU, Brazil Inclusion criteria: age ≥ 18; AHRF of any cause on admission or post‐extubation; do‐not‐intubate order; dyspnoea (Borg scale ≥ 4); SpO2 < 90% or PaO2 < 60 mmHg on room air; absence of delirium; signs of respiratory distress and use of accessory muscles or respiratory rate > 25 breaths/min Exclusion criteria: refusal of treatment; agitation or non‐co‐operation; delirium at randomization; anatomical abnormalities that would interfere with NIV mask; GCS < 12; psychomotor agitation requiring sedation; contraindications to NIV; pneumothorax or extensive pleural effusion; moribund
Interventions	Intervention group (HFNC): AIRVO 2, Fisher & Paykel Healthcare, Auckland, New Zealand; offered until resolution of AHRF or intolerance; flow = 45 L/min titrated to 60 L/min or highest tolerable flow; FiO2 = 0.5 titrated to SpO2 = 92 to 98% Control group (standard oxygen therapy): SpO2 targeted 90‐98%; NIV at discretion of the treatment team
Outcomes	All outcomes reported: dyspnoea; comfort; opioid dose; delirium; ICU length of stay; mortality (28 day); use of respiratory support devices Outcomes relevant to this review: comfort; ICU length of stay; mortality; use of respiratory support devices (if NIV/MV)
Starting date	17 February 2020
Contact information	Israel Maia, israils.maia@gmail.com. Leticia Kawano‐Dourado, ldourado@hcor.com.br
Notes