UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036378
Receipt number R000041424
Scientific Title Study on the effect of High-Flow Nasal Cannula on exercise duration of patients with interstitial lung disease
Date of disclosure of the study information 2019/05/01
Last modified on 2023/04/27 17:43:13

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Basic information

Public title

Study on the effect of High-Flow Nasal Cannula on exercise duration of patients with interstitial lung disease

Acronym

Study on the effect of High-Flow Nasal Cannula on exercise duration of patients with interstitial lung disease

Scientific Title

Study on the effect of High-Flow Nasal Cannula on exercise duration of patients with interstitial lung disease

Scientific Title:Acronym

Study on the effect of High-Flow Nasal Cannula on exercise duration of patients with interstitial lung disease

Region

Japan


Condition

Condition

Interstitial lung disease

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effect of High-flow nasal cannula on exercise duration in patients with interstitial lung disease

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Endurance time of bicycle ergometer according to High-flow nasal cannula setting condition

Key secondary outcomes

Subjective dyspnea while performing a bicycle ergometer with High-flow nasal cannula settings


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Room air

Interventions/Control_2

High-flow nasal cannula(FiO2 0.21, Flow 40L/min)

Interventions/Control_3

High-flow nasal cannula(FiO2 0.6, Flow 40L/min)

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

40 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1, Patients with stable interstitial lung disease who are hospitalized for the purpose of introducing steroids, pirfenidone and nintedanib
2, Age at the time of consent acquisition is over 40 years old and under 80 years old
3, Informed consent can be obtained in writing from the person

Key exclusion criteria

1, Having collagen disease, neuromuscular disease, or orthopedic disease that may affect exercise tolerance assessment at enrollment
2, Requires antiarrhythmic treatment
3, Clinically complicated with severe pulmonary antihypertension
4, Researcher decides that it is not appropriate to register for this exam
5, Patients with malignant tumors whose recurrence has not been confirmed for over 3 years
6, Home oxygen therapy introduction patient

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Yanagita
Middle name
Last name Yorihide

Organization

Seirei Mikatahara General Hospital

Division name

Dept. of Rehabilitation

Zip code

433-8558

Address

3453 Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka

TEL

053-436-1251

Email

dependonhero@yahoo.co.jp


Public contact

Name of contact person

1st name Yanagita
Middle name
Last name Yorihide

Organization

Seirei Mikatahara General Hospital

Division name

Dept. of Rehabilitation

Zip code

433-8558

Address

3453 Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka

TEL

053-436-1251

Homepage URL


Email

dependonhero@yahoo.co.jp


Sponsor or person

Institute

Seirei Mikatahara General Hospital, Dept. of Rehabilitation

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Seirei Mikatahara General Hospital

Address

3453 Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka

Tel

053-436-1251

Email

dependonhero@yahoo.co.jp


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

聖隷三方原病院(静岡県)


Other administrative information

Date of disclosure of the study information

2019 Year 05 Month 01 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

Enrolling by invitation

Date of protocol fixation

2019 Year 04 Month 01 Day

Date of IRB

2019 Year 06 Month 07 Day

Anticipated trial start date

2019 Year 07 Month 01 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry

2023 Year 10 Month 01 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 04 Month 02 Day

Last modified on

2023 Year 04 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041424


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name