JPRN‐jRCTs052180236.
| Study name | Japanese, multicenter, randomized controlled trial of noninvasive positive pressure ventilation (NPPV) versus high‐flow nasal cannula oxygen therapy (HFNC) for severe acute hypoxemic respiratory failure ‐ Ja‐NP‐Hi trial |
| Methods | RCT, parallel‐group design |
| Participants | Estimated number of participants: 104 Setting: Inclusion criteria: acute respiratory failure, which occurred within 1 week of a known clinical insult or new or worsening respiratory symptoms; new infiltrates on chest radiography; PaO2/FiO2 < 300 at screening; PaCO2 ≤ 45 Torr at screening; age > 20; written informed consent Exclusion criteria: urgent need for endotracheal intubation; respiratory failure fully explained by cardiac failure or fluid overload; exacerbation of asthma; pulmonary embolism; received NPPV or HFNC for > 24 hours at the time of the informed consent; chronic pulmonary disease; malignant tumour affecting the efficacy endpoints; contraindications either to NPPV or HFNC; major surgery within 4 weeks; severe leukopenia; haemodynamic instability; need for vasopressors; GCS ≤ 12 points; received NPPV or HFNC within the past 4 weeks prior to the informed consent; use of NPPV or HFNC at home (more than 6 hours/day); tracheostomy; pregnancy; cognitive impairment or mental disorder; participated in another study or will participate in another study; any other cases who are regarded as inadequate for the study enrolment by the investigators |
| Interventions | Intervention group (HFNC) Control group (NPPV) |
| Outcomes | All outcomes measured: intubation rate; 28‐day mortality; in‐hospital mortality; ventilator‐free days; oxygenation; arterial blood gas analysis; duration of respiratory support; length of hospital stay; adverse events; need for continuous sedation Outcomes relevant to this review: intubation rate; 28‐day mortality; oxygenation; arterial blood gas analysis; duration of respiratory support; length of hospital stay; adverse events |
| Starting date | 30 March 2019 |
| Contact information | Kazuma Nagata, kazuma_n1101@yahoo.co.jp. Keisuke Tomii, ktomii@kcho.jp |
| Notes |