UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023371
Receipt number R000026888
Scientific Title Comparison of an ordinary mask and an open face mask
Date of disclosure of the study information 2016/07/29
Last modified on 2020/07/31 11:05:36

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Basic information

Public title

Comparison of an ordinary mask and an open face mask

Acronym

The open face mask study

Scientific Title

Comparison of an ordinary mask and an open face mask

Scientific Title:Acronym

The open face mask study

Region

Japan


Condition

Condition

respiratory failure

Classification by specialty

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We hypothesize that the use of an open face mask is better for our spontaneous breathing patients who need oxygen than an ordinary mask because it can give patients better oxygenation and CO2 clearance.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Fraction of inspired carbon dioxide
(FICO2) after 15 minutes of 5L/min oxygen, and with variable flows(4,3,2,1 and 0.5L/min: the flow is decreased every 3 minutes) by using an open face mask and an ordinary mask.

Key secondary outcomes

Respiratory rate, end-tidal CO2, SpO2 and patients' satisfaction with the mask, under the same conditions.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

We applied both masks (ordinary and open face mask) with various flow rates: 5, 4, 3, 2, 1 and 0.5 l/min for three minutes, respectively. First, we tried ordinary masks with 5 l/min for 15 minutes and decreased the flow to 0.5 l/min every three minutes.
FICO2 and EtCO2 were measured via CapnostreamTM (Medtronic, US).

Interventions/Control_2

Next, we investigated an open face mask in the same manner: applying 5 l/min of oxygen for 15 minutes. Finally, we checked patient satisfaction with each mask using a visual analogue scale (VAS: 0-best, 5-worst) at the end of each trial.

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

18 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Stable ICU patients who suffered from mild respiratory failure

Key exclusion criteria

The patients who are not arousal.
The patients who are unstable.
The patients who need positive pressure ventilation to maintain their SpO2.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kaneyuki
Middle name
Last name Kawamae

Organization

Yamagata University Faculty of Medicine

Division name

Department of Anesthesiology and Critical Care Medicine

Zip code

990-2331

Address

2-2-2, Iida-nishi, Yamagata, Yamagata, Japan

TEL

023-628-5400

Email

kkawamae@yamagata-u.med.id.jp


Public contact

Name of contact person

1st name Tadahiro
Middle name
Last name Kobayashi

Organization

Yamagata University Faculty of Medicine

Division name

Department of Emergency and Critical Care Medicine

Zip code

990-2331

Address

2-2-2, Iida-nishi, Yamagata, Yamagata, Japan

TEL

023-628-5400

Homepage URL


Email

tad.kob11@gmail.com


Sponsor or person

Institute

Yamagata University

Institute

Department

Personal name



Funding Source

Organization

Yamagata University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Yamagata University Faculty of Medicine

Address

2-2-2, Iida-Nishi, Yamagata

Tel

023-628-5047

Email

ikekenkyu@jm.kj.yamagata-u.ac.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

山形大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2016 Year 07 Month 29 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

No longer recruiting

Date of protocol fixation

2015 Year 12 Month 22 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2018 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 07 Month 28 Day

Last modified on

2020 Year 07 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026888


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name