Japanese, multicenter, randomized controlled trial of noninvasive positive pressure ventilation (NPPV) versus high-flow nasal cannula oxygen therapy (HFNC) for acute hypoxemic respiratory failure

Not Applicable

• Conditions: acute hypoxemic respiratory failure

• Registration Number: JPRN-UMIN000028827
• Lead Sponsor: Kobe City Medical Center General Hospital Department of Respiratory Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-25
• Study Completion: 2021-03-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients with urgent need for endotracheal intubation. 2. Patients with respiratory failure fully explained by cardiac failure or fluid overload. 3. Patients with COVID-19. 4. Patients with exacerbation of asthma. 5. Patients with pulmonary embolism. 6. Patients who have received NPPV or HFNC for more than 24 hours at the time of the informed consent. 7. Patients who have the following chronic pulmonary disease. a. Chronic interstitial pneumonia apparent on chest radiography. b. Chronic pulmonary disease affecting the efficacy endpoints (for example; COPD, tuberculosis sequelae, bronchiectasis, pneumoconiosis etc.). c. Chronic respiratory failure with need for home oxygen therapy (more than 12 hours/day). d. Chronic pulmonary disease that are regarded as inadequate for the study by the investigators. 8. Patients with active malignant tumor affecting the efficacy endpoints. 9. Patients with contraindications either to NPPV or HFNC, such as undrained pneumothorax, upper airway obstruction, facial trauma, injury and deformity etc. 10. Patients with major surgery within 4 weeks prior to the time of the informed consent. 11. Patients with severe leukopenia (WBC < 1000 per microliter of blood). 12. Patients with hemodynamic instability (systolic blood pressure < 90 mmHg after fluid administration). 13. Patients with need for vasopressors. 14. Patients with altered consciousness (Glasgow Coma Scale <= 12 points. 15. Patients who have received NPPV or HFNC within the past 4 weeks prior to the informed consent, or are using NPPV or HFNC at home (more than 6 hours/day). 16. Patients with tracheostomy. 17. Patients who are pregnant. 18. Patients with cognitive impairment or mental disorder who are regarded as inadequate to evaluate for the study by the investigators. 19. Patients who have participated in the other study at the time of the informed consent, or will participate in the other study. 20. Any other cases who are regarded as inadequate for the study enrollment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Term from randomization to meeting criteria for endotracheal intubation censored at 28 days.

Secondary Outcome Measures

Name	Time	Method
1. Proportion of patients who required endotracheal intubation within 28 days after randomization. 2. Mortality at 28 days 3. In-hospital mortality 4. Ventilator-free days 5. Change of oxygenation (PaO2/FIO2) 6. Arterial blood gas analysis 7. Duration of need for any respiratory support 8. Duration of hospital stay for respiratory illness 9. Adverse events 10. Need for Continuous sedation (Drug, dose, duration)