UMIN-CTR Clinical Trial

Basic information
Public title	Japanese, multicenter, randomized controlled trial of noninvasive positive pressure ventilation (NPPV) versus high-flow nasal cannula oxygen therapy (HFNC) for acute hypoxemic respiratory failure
Acronym	Study of NPPV versus HFNC for acute hypoxemic respiratory failure (Ja-NP-Hi trial)
Scientific Title	Japanese, multicenter, randomized controlled trial of noninvasive positive pressure ventilation (NPPV) versus high-flow nasal cannula oxygen therapy (HFNC) for acute hypoxemic respiratory failure
Scientific Title:Acronym	Study of NPPV versus HFNC for acute hypoxemic respiratory failure (Ja-NP-Hi trial)
Region	Japan

Condition
Condition	acute hypoxemic respiratory failure
Classification by specialty	Pneumology Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Term from randomization to meeting criteria for endotracheal intubation censored at 28 days.
Key secondary outcomes	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)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Arm A (NPPV): Subjects receive NPPV as a protocol treatment.
Interventions/Control_2	Arm B (HFNC): Subjects receive HFNC as a protocol treatment.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion 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.
Key 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.
Target sample size	104

Research contact person
Name of lead principal investigator	1st name Middle name Last name Keisuke Tomii
Organization	Kobe City Medical Center General Hospital
Division name	Department of Respiratory Medicine
Zip code
Address	2-1-1 Minatojima-minamimachi, Chuo-ku, Kobe
TEL	078-302-4321
Email	ktomii@kcho.jp

Public contact
Name of contact person	1st name Middle name Last name Kazuma Nagata
Organization	Kobe City Medical Center General Hospital
Division name	Department of Respiratory Medicine
Zip code
Address	2-1-1 Minatojima-minamimachi, Chuo-ku, Kobe
TEL	078-302-4321
Homepage URL
Email	kazuma_n1101@yahoo.co.jp

Sponsor
Institute	Kobe City Medical Center General Hospital Department of Respiratory Medicine
Institute
Department

Funding Source
Organization	Philips Respironics
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	神戸市立医療センター中央市民病院、JA広島総合病院、倉敷中央病院、松阪市民病院、仙台厚生病院、伊勢赤十字病院、島根大学医学部附属病院、亀田総合病院、公立陶生病院、長野赤十字病院、愛媛県立中央病院、大垣市民病院、麻生飯塚病院、聖路加国際病院、広島大学医学部附属病院、済生会熊本病院、KKR高松病院、姫路医療センター、天理よろづ病院、松江医療センター、済生会宇都宮病院

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 22 Day
Date of IRB	2020 Year 02 Month 04 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date	2021 Year 03 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 08 Month 25 Day
Last modified on	2022 Year 02 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032953