UMIN-CTR Clinical Trial

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

acute hypoxemic respiratory failure

Classification by specialty

Pneumology	Emergency medicine	Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

Kobe City Medical Center General Hospital
Department of Respiratory Medicine

Institute

Department

Personal name

Organization

Philips Respironics

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2017

Year

08

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

08

Month

25

Day

Last modified on

2022

Year

02

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032953