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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028827
Receipt No. R000032953
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
Date of disclosure of the study information 2017/08/25
Last modified on 2018/08/09

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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 exacerbation of asthma.
4. Patients with pulmonary embolism.
5. Patients who have received NPPV or HFNC for more than 24 hours at the time of the informed consent.
6. 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.
7. Patients with active malignant tumor affecting the efficacy endpoints.
8. Patients with contraindications either to NPPV or HFNC, such as undrained pneumothorax, upper airway obstruction, facial trauma, injury and deformity etc.
9. Patients with major surgery within 4 weeks prior to the time of the informed consent.
10. Patients with severe leukopenia (WBC < 1000 per microliter of blood).
11. Patients with hemodynamic instability (systolic blood pressure < 90 mmHg after fluid administration).
12. Patients with need for vasopressors.
13. Patients with altered consciousness (Glasgow Coma Scale <= 12 points.
14. 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).
15. Patients with tracheostomy.
16. Patients who are pregnant.
17. Patients with cognitive impairment or mental disorder who are regarded as inadequate to evaluate for the study by the investigators.
18. Patients who have participated in the other study at the time of the informed consent, or will participate in the other study.
19. Any other cases who are regarded as inadequate for the study enrollment by the investigators.
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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
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
2018 Year 08 Month 09 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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