UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026346
Receipt number R000030229
Scientific Title Intrathoracic pressure measurement during Nasal High-flow Oxygen Therapy System (NHF-OTS)
Date of disclosure of the study information 2017/03/01
Last modified on 2019/09/02 12:51:19

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Basic information

Public title

Intrathoracic pressure measurement during Nasal High-flow Oxygen Therapy System (NHF-OTS)

Acronym

Intrathoracic pressure measurement during Nasal High-flow Oxygen Therapy System (NHF-OTS)

Scientific Title

Intrathoracic pressure measurement during Nasal High-flow Oxygen Therapy System (NHF-OTS)

Scientific Title:Acronym

Intrathoracic pressure measurement during Nasal High-flow Oxygen Therapy System (NHF-OTS)

Region

Japan


Condition

Condition

Volunteers

Classification by specialty

Pneumology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The physiological mechanisms of the constant-flow and constant-pressure models of the Nasal High-flow Oxygen Therapy System are studied.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The physiological mechanisms of the constant-flow and constant-pressure models of NHF-OTS study in 10 volunteers by esophageal balloon methods, electrical impedance method, and the forced oscillation technique (FOT).

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

6

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Steady air Atom Medical,Japan 30L/min 5minutes

Interventions/Control_2

Steady air Atom Medical,Japan 50L/min 5minutes

Interventions/Control_3

AIRVO2, Optiflow Fisher&Paykel, New Zealand
30L/min 5minutes

Interventions/Control_4

AIRVO2, Optiflow Fisher&Paykel, New Zealand
50L/min 5minutes

Interventions/Control_5

Vivo 50 Breas Medical AB, Sweden PMH7000plus Pacific Medico Co. Ltd.,Japan nasal cannula No.3Pacific Medico Co. Ltd.,Japan 30L/min 5minutes

Interventions/Control_6

Vivo 50 Breas Medical AB, Sweden PMH7000plus Pacific Medico Co. Ltd.,Japan nasal cannula No.3Pacific Medico Co. Ltd.,Japan 50L/min 5minutes

Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

25 years-old <=

Age-upper limit

45 years-old >=

Gender

Male

Key inclusion criteria

Ten healthy adult Japanese men are enrolled
in the study.

Key exclusion criteria

Respiratory dysfunction

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Miyuki Okuda

Organization

Hirakata Kohsai Hospital

Division name

Respiratory medicine

Zip code


Address

1-2-1-,Fujisakahigashimachi, Hirakata

TEL

072-858-8233

Email

ryoheikunn@msf.biglobe.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Miyuki Okuda

Organization

Hirakata Kohsai Hospital

Division name

Respiratory medicine

Zip code


Address

1-2-1-,Fujisakahigashimachi, Hirakata

TEL

072-858-8233

Homepage URL


Email

ryoheikunn@msf.biglobe.ne.jp


Sponsor or person

Institute

Hirakata Kohsai Hospital

Institute

Department

Personal name



Funding Source

Organization

Hirakata Kohsai Hospital

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


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



Other administrative information

Date of disclosure of the study information

2017 Year 03 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

Main results already published

Date of protocol fixation

2017 Year 03 Month 01 Day

Date of IRB

2017 Year 02 Month 25 Day

Anticipated trial start date

2017 Year 03 Month 01 Day

Last follow-up date

2018 Year 03 Month 01 Day

Date of closure to data entry

2018 Year 03 Month 01 Day

Date trial data considered complete

2018 Year 03 Month 01 Day

Date analysis concluded

2018 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2017 Year 03 Month 01 Day

Last modified on

2019 Year 09 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030229


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name