UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029488 |
|---|---|
| Receipt number | R000033694 |
| Scientific Title | Usefulness of acoustic monitoring of respiratory rate in patients undergoing gastric ESD |
| Date of disclosure of the study information | 2017/10/16 |
| Last modified on | 2019/04/22 15:17:49 |
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Basic information
Public title
Usefulness of acoustic monitoring of respiratory rate in patients undergoing gastric ESD
Acronym
Usefulness of acoustic monitoring of RR in patients undergoing gastric ESD
Scientific Title
Usefulness of acoustic monitoring of respiratory rate in patients undergoing gastric ESD
Scientific Title:Acronym
Usefulness of acoustic monitoring of RR in patients undergoing gastric ESD
Region
| Japan |
Condition
Condition
gastric tumor(early gastric cancer or gastric adenoma)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the usefulness of acoustic monitoring of respiratory rate(Mshimo Radical-7) in patients undergoing gastric ESD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
respiratory rate
Key secondary outcomes
oxygen saturation,blood pressure,oxigen dose,target blood concentration and propofol doze,sedation time,body mass index,ASA classification,underlying diseases
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients will be monitored for their respiration with pulse oximetry during ESD.
Interventions/Control_2
Patients will be monitored for their respiration with pulse oximetry and acoustic monitoring of respiratory rate (Mashimo Radical-7).
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
Patients with early gastric cancer or gastric adenoma who are scheduled for ESD using propofol sedation.
Key exclusion criteria
Patients were excluded if they were <20 years of age,had a history of egg or soybean allergy,were unable to provide informed consent or were judged inappropriate for ESD by the doctor.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigenao Ishikawa |
Organization
Kagawa Prefectural Central Hospital
Division name
Gastroenterology
Zip code
Address
1-2-1 Asahi-machi,Takamatsu-city,Kagawa,Japan
TEL
087-811-3333
ishikawa5308@yohoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kumiko Yamamoto |
Organization
Kagawa Prefectural Central Hospital
Division name
Gastroenterology
Zip code
Address
1-2-1 Asahi-machi,Takamatsu-city,Kagawa,Japan
TEL
087-811-3333
Homepage URL
kmyamamoto1@gmail.com
Sponsor or person
Institute
Kagawa Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Kagawa Prefectural Central Hospital
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
Address
Tel
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
| 2017 | Year | 10 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 10 | Day |
Last modified on
| 2019 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033694
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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