Ja-NP-Hi trial

JRCT ID: jRCTs052180236

Registered date:30/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: acute hypoxemic respiratory failure
• Date of first enrollment: 26/01/2018
• Target sample size: 104
• Study type: Interventional
• Intervention(s): This is a prospective, randomized parallel study for demonstrating superiority of noninvasive positive pressure ventilation (NPPV) compared to high-flow nasal cannula oxygen therapy (HFNC) in acute hypoxemic respiratory failure in terms of the term from randomization to meeting criteria for endotracheal intubation.

Outcome(s)

• Primary Outcome: Term from randomization to meeting criteria for endotracheal intubation censored at 28 days.

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients who have acute respiratory failure, which occures within 1 week of a known clinical insult or new or worsening respiratory symptoms.
2. Patients who have new infiltrates on chest radiography.
3. Patients with PaO2/FIO2 < 300 at screening.
4. Patients with PaCO2 <= 45 Torr at screening.
5. Patients who are more than 20 years old at the time of the informed consent.
6. Patients who agree to participate in the study with the written informed consent.

Exclude 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 by the investigators.

Related Information

• Primary Sponsor: Tomii Keisuke
• Source(s) of Monetary Support: Philips Japan
• Secondary ID(s): UMIN000028827