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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008329
Receipt No. R000009803
Scientific Title Clinical trial of the non-invasive pulseoxymeter and respiratory rate monitering for post-operative patients.
Date of disclosure of the study information 2012/07/15
Last modified on 2019/07/09

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Basic information
Public title Clinical trial of the non-invasive pulseoxymeter and respiratory rate monitering for post-operative patients.
Acronym Clinical trial of the non-invasive pulseoxymeter and respiratory rate monitering for post-operative patients.
Scientific Title Clinical trial of the non-invasive pulseoxymeter and respiratory rate monitering for post-operative patients.
Scientific Title:Acronym Clinical trial of the non-invasive pulseoxymeter and respiratory rate monitering for post-operative patients.
Region
Japan

Condition
Condition patients undergoing surgery
Classification by specialty
Surgery in general Obsterics and gynecology Pediatrics
Oto-rhino-laryngology Orthopedics Anesthesiology
Neurosurgery Cardiovascular surgery Plastic surgery
Operative medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Peripheral arterial saturation and raspiratory rate are continuously monitored after the emergence from general anesthesia to post-operative day 2.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We investigate the raspiratory depression that is a side effect of general anesthetics and the opioid analgesics.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who received post-operative management in the general surgical words or intensive care unit.
Patients who obtained the informed consent.
Key exclusion criteria Patiengts who could not attach the acoustic resiratory rate sensor to their anterior neck.
Patient's refusal
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Yasunori
Middle name
Last name Niwa
Organization Jichi Medical University
Division name Department of Anesthesiology and Critical Care Medicine
Zip code 3290498
Address 3311-1 Yakushiji Shimotsuke-shi Tochi, Japan
TEL 0285587383
Email yasu-niw@jichi.ac.jp

Public contact
Name of contact person
1st name Yasunori
Middle name
Last name Niwa
Organization Jichi Medical University
Division name Department of anesthesiology and Critical Care Medicine
Zip code 3290498
Address 3311-1 Yakushiji Shimotsuke-shi Tochigi, Japan
TEL 0285587383
Homepage URL
Email yasu-niw@jichi.ac.jp

Sponsor
Institute Jichi Medical University
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 Jichi Medical University Department of Anesthesiology and Critical Care Medicine
Address 3311-1, Yakushiji, Shimotsuke-City, Tochigi-Pref,
Tel 0285587383
Email yasu-niw@jichi.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 自治医科大学附属病院(栃木県)

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 15 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 Enrolling by invitation
Date of protocol fixation
2012 Year 04 Month 09 Day
Date of IRB
2012 Year 04 Month 09 Day
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2015 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective study

Management information
Registered date
2012 Year 07 Month 03 Day
Last modified on
2019 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009803

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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