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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021631
Receipt No. R000024374
Scientific Title Which monitor is superior to detect apnea of a healthy adult volunteer between using respiratory sound and plethysmography?
Date of disclosure of the study information 2016/04/01
Last modified on 2017/04/29

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Basic information
Public title Which monitor is superior to detect apnea of a healthy adult volunteer between using respiratory sound and plethysmography?
Acronym Which monitor is superior to detect apnea?
Scientific Title Which monitor is superior to detect apnea of a healthy adult volunteer between using respiratory sound and plethysmography?
Scientific Title:Acronym Which monitor is superior to detect apnea?
Region
Japan

Condition
Condition healthy adult volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to identify the best monitor to detect apnea promptly when sensors are applied fingertip and/or neck instead of near the mouth and the nose.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time until detecting apnea by either the monitor after the volunteer stop regular breathing.
Key secondary outcomes Respiratory rate(RR) during regular breathing
Time until showing RR and diminished alarm of the monitor
Change of oxygen saturation by apnea

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 The volunteers are applied sensors of Masimo New Radical-7 and Nellcor PM1000N. They breathe at the rate of 12/min by the metronome for 3 min and then they stop breathing for 15-30 sec. If apnea is detected by either the monitor, breathing is resumed. When they feel dyspnea, they may resume breathing.
We record below.
Time until apnea alarm after the volunteer stop regular breathing.
Time until showing respiratory rate on the monitor, and diminished alarm when they resume breathing.
RR, oxygen saturation and pulse rate every 30 seconds.
Research time is about 15 minutes.
Interventions/Control_2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy adult volunteer.
Key exclusion criteria A subject shows respiratory symptom at research time.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Ozaki
Organization Tokyo Women's Medical University, School of medicine
Division name Department of Anesthesiology
Zip code
Address 8-1 Kawadacho Shinjukuku,Tokyo,Japan
TEL 03-3353-8111
Email mozaki@anes.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Fukuda
Organization Tokyo Women's Medical University, School of medicine
Division name Department of Anesthesiology
Zip code
Address 8-1 Kawadacho Shinjukuku,Tokyo,Japan
TEL 03-3353-8111
Homepage URL
Email tfukada@anes.twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University, School of medicine
Institute
Department

Funding Source
Organization Tokyo Women's Medical University, School of medicine
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 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 03 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2016 Year 07 Month 20 Day
Date of closure to data entry
2016 Year 09 Month 30 Day
Date trial data considered complete
2016 Year 09 Month 30 Day
Date analysis concluded
2016 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 03 Month 27 Day
Last modified on
2017 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024374

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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