UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023307
Receipt number R000024258
Scientific Title A preliminary study nasopharyngeal pressure is increased by the concomitant use of a nasal high flow cannula with surgical face mask in healthy volunteers
Date of disclosure of the study information 2016/07/23
Last modified on 2017/04/17 12:54:35

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Basic information

Public title

A preliminary study nasopharyngeal pressure is increased by the concomitant use of a nasal high flow cannula with surgical face mask in healthy volunteers

Acronym

Nasopharyngeal pressure is increased by the concomitant use of a nasal high flow cannula with surgical face mask

Scientific Title

A preliminary study nasopharyngeal pressure is increased by the concomitant use of a nasal high flow cannula with surgical face mask in healthy volunteers

Scientific Title:Acronym

Nasopharyngeal pressure is increased by the concomitant use of a nasal high flow cannula with surgical face mask

Region

Japan


Condition

Condition

healthy volunteers

Classification by specialty

Anesthesiology Emergency medicine Intensive care medicine
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

During nasal high flow therapy, we consider a CPAP effect can be obtained by mimicking a closed-mouth state using a surgical face mask even in the mouth open.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

change in the nasopharyngeal pressure

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

4

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

No oxygen therapy(in the mouth open)

Interventions/Control_2

Nasal high flow(in the mouth open)

Interventions/Control_3

Nasal high flow(in the mouth open) plus surgical face mask

Interventions/Control_4

Nasal high flow(in the mouth close)

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

nurses who work in ICU at Fujita Health University School of Medicine

Key exclusion criteria

(1)state treating a respiratory disease

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Osamu Nishida

Organization

Fujita Health University School of Medicine

Division name

Department of Anesthesiology and Critical Care Medicine

Zip code


Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan

TEL

0562-93-9008

Email

nishida@fujita-hu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Komatsu

Organization

Fujita Health University School of Medicine

Division name

Department of Anesthesiology and Critical Care Medicine

Zip code


Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan

TEL

0562-93-9008

Homepage URL


Email

mind_koma@yahoo.co.jp


Sponsor or person

Institute

Fujita Health University School of Medicine, Department of Anesthesiology and Critical Care Medicine

Institute

Department

Personal name



Funding Source

Organization

none

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

2016 Year 07 Month 23 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

2016 Year 06 Month 30 Day

Date of IRB


Anticipated trial start date

2016 Year 07 Month 23 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

2016 Year 07 Month 23 Day

Last modified on

2017 Year 04 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024258


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name