UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042114 |
|---|---|
| Receipt number | R000048054 |
| Scientific Title | The biological transparent illumination light detects correct position of nasogastric tube in surgical patients under general anesthesia; Safe, fast, and simple technique |
| Date of disclosure of the study information | 2020/10/14 |
| Last modified on | 2024/01/11 10:34:13 |
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Basic information
Public title
The effectiveness of biological transparent illumination light to detect correct position of nasogastric tube
Acronym
Detection of position of nasogastric tube by the light
Scientific Title
The biological transparent illumination light detects correct position of nasogastric tube in surgical patients under general anesthesia; Safe, fast, and simple technique
Scientific Title:Acronym
BT-light detect the correct position of nasogastric tube
Region
| Japan |
Condition
Condition
The patients undergoing genaral surgery with general anesthesia
Classification by specialty
| Surgery in general | Anesthesiology | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study was designed to confirm the effectiveness of biological transparent illumination light to detect correct position of nasogastric tube (NGT) in surgical patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity and specificity of BT-light technique
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who need gastric decompression due to mask-bag ventilation after induction of general anesthesia undergoing general surgeries.
Key exclusion criteria
Not paticular patient
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Masaki |
Organization
International University of Health and Welfare Hospital
Division name
Anesthesiology
Zip code
329-2763
Address
537-3 Iguchi, Nasushiobara Tochigi 329-2763, Japan
TEL
0287-37-2221
ejmasaki@gmail.com
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Masaki |
Organization
International University of Health and Welfare Hospital
Division name
Anesthesiology
Zip code
329-2763
Address
537-3 Iguchi, Nasushiobara Tochigi 329-2763, Japan
TEL
0287-37-2221
Homepage URL
ejmasaki@gmail.com
Sponsor or person
Institute
Department of Anesthesiology, International University of Health and Welfare Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, International University of Health and Welfare Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
International University of Health and Welfare Hospital
Address
537-3 Iguchi, Nasushiobara Tochigi 329-2763, Japan
Tel
0287-37-2221
mohwada@iuhw.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 14 | Day |
Related information
URL releasing protocol
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0250258
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0250258
Number of participants that the trial has enrolled
102
Results
This study shows that biologically transparent illumination is a useful and safe technique for detecting the correct position of the nasogastric tube and might avoid serious complications due to malposition of the nasogastric tube.
Results date posted
| 2021 | Year | 04 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 04 | Month | 29 | Day |
Baseline Characteristics
Surgical patients
Participant flow
at random
Adverse events
None
Outcome measures
Identification of BT-light
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 01 | Month | 24 | Day |
Date trial data considered complete
| 2021 | Year | 01 | Month | 25 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 25 | Day |
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 10 | Month | 14 | Day |
Last modified on
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048054
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
