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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007661
Receipt No. R000009027
Scientific Title Is acoustic monitoring using MASIMO Rad-87 useful for measuring respiratory rate of postoperative patients? (Observation study)
Date of disclosure of the study information 2012/06/01
Last modified on 2013/10/05

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Basic information
Public title Is acoustic monitoring using MASIMO Rad-87 useful for measuring respiratory rate of postoperative patients? (Observation study)
Acronym Usefulness of acoustic monitoring for measuring respiratory rate (Observation study)
Scientific Title Is acoustic monitoring using MASIMO Rad-87 useful for measuring respiratory rate of postoperative patients? (Observation study)
Scientific Title:Acronym Usefulness of acoustic monitoring for measuring respiratory rate (Observation study)
Region
Japan

Condition
Condition patient undergoing surgery
Classification by specialty
Surgery in general Orthopedics Urology
Anesthesiology Plastic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Respiratory rate measured using acoustic monitoring was compared with respiratory rate by visual measurement or using impedance method or capnograph.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Respiratory rate measured using acoustic monitoring is consistent with respiratory rate by visual measurement.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 A patient is over 20 years old.
A patient goes into PACU after the end of an operation.
A patient who we obtain the informed consent
Key exclusion criteria A patient cannot carry a sensor.
A patient is judged that he or she is unsuitable as a subject.
Target sample size 100

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 Shinjuku-ku Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Fukada
Organization Tokyo Women's Medical University, School of Medicine
Division name Department of Anesthesiology
Zip code
Address
TEL 03-3353-8111
Homepage URL
Email

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

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
2012 Year 06 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
RRa&#8482; correlated well with visual inspection of chest movement. Even in obese patients, RRa&#8482; showed small difference and good correlation and in patients with RR &#8804;10 per min, a moderate correlation was seen between only RRa&#8482; and visual inspection of chest movement.
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
2012 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2013 Year 02 Month 27 Day
Date of closure to data entry
2013 Year 03 Month 28 Day
Date trial data considered complete
2013 Year 03 Month 28 Day
Date analysis concluded
2013 Year 06 Month 30 Day

Other
Other related information Prospective study
Random sample

Management information
Registered date
2012 Year 04 Month 04 Day
Last modified on
2013 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009027

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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