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 | 2024/08/03 09:48:09 |
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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
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
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
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
20
Results
Open-face mask is more comfortable for the patients than ordinary oxygen mask. In higher flow of oxygen, open face mask is more effective to give high FIO2 to the patients.
Results date posted
| 2024 | Year | 08 | Month | 03 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Now, writing the articles. Due to COVID19, the final step of this research is delayed.
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
| 2024 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026888
