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 | 2025/04/23 10:44:55 |
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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 | Shigenao |
| Middle name | |
| Last name | Ishikawa |
Organization
Kagawa Prefectural Central Hospital
Division name
Gastroenterology
Zip code
7608557
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 | Kumiko |
| Middle name | |
| Last name | Yamamoto |
Organization
Kagawa Prefectural Central Hospital
Division name
Gastroenterology
Zip code
7608557
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
Kagawa Prefectural Central Hospital
Address
Asahi-machi,Takamatsu-city,Kagawa,Japan
Tel
087-811-3333
ku-yamamoto@chp-kagawa.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 16 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/gee/61/Supplement1/61_855/_pdf/-char/ja
Publication of results
Unpublished
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/gee/61/Supplement1/61_855/_pdf/-char/ja
Number of participants that the trial has enrolled
100
Results
The frequency of respiratory depression was 37.3% in the single group and 38.8% in the combination group,with no significant difference observed (P=0.88).The BIS values and target blood concentrations during respiratory depression were an average of 72.5/77.5 and 1.60/1.65 microgram/ml,respectively. The average respiratory rate during respiratory depression in the combination group was 13.9 breaths. Within the scope of this study, no additional effectiveness of respiratory monitoring was recognized.
Results date posted
| 2025 | Year | 04 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The subjects were patients aged 20 years or older who had consented to this trial and were scheduled to undergo ESD for early gastric cancer. A total of 103 cases were registered from December 2017 to July 2018, with one case discontinued from treatment and two cases excluded as ineligible.
Participant flow
From December 2017 to July 2018, 103 cases were registered, with 1 case dropping out due to treatment discontinuation and 2 cases excluded as ineligible. Adjustment factors of age, gender, and BMI were used for allocation, and the study examined 51 cases in the pulse oximeter only group and 49 cases in the respiratory rate monitor combined group.
Adverse events
No significant adverse events.
Outcome measures
During the procedure, adjustments were made based on changes in BIS values　 and/or increases during body movement and/or reductions in cases of blood pressure drop and a respiratory rate of 10 breaths/minute or less. An SPO2 value of 90% or lower was defined as respiratory suppression and was established as the criteria for starting oxygen administration. The preventive effects and costs of respiratory suppression were discussed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 25 | Day |
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
| 2025 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033694
