UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056249 |
|---|---|
| Receipt number | R000064265 |
| Scientific Title | study on appropriate breathing techniques during transnasal endoscopy |
| Date of disclosure of the study information | 2024/11/25 |
| Last modified on | 2025/05/26 18:47:22 |
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Basic information
Public title
study on appropriate breathing techniques during transnasal endoscopy
Acronym
breathing techniques during transnasal endoscopy
Scientific Title
study on appropriate breathing techniques during transnasal endoscopy
Scientific Title:Acronym
breathing techniques during transnasal endoscopy
Region
| Japan |
Condition
Condition
having no symptoms or exhibiting abdominal symptoms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aims to identify the optimal breathing method during transnasal endoscopy by assigning patients undergoing the procedure into two groups: one group will perform nasal breathing throughout the entire examination, while the other group will switch from nasal breathing to oral breathing after reaching the esophageal entrance. The patients' tolerance and the ease of endoscope insertion will be compared and analyzed between the groups.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
patient tolerance and endoscopist operability
Key secondary outcomes
patency of the upper to middle pharynx, endoscopic insertion time, and adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
the group performing nasal breathing throughout the entire procedure
Interventions/Control_2
the group switching from nasal breathing to oral breathing after insertion at the esophageal entrance
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 aged 20 years or older at the time of consent.
Patients who agree to undergo transnasal endoscopy.
Patients who have provided written informed consent to participate in this study.
Key exclusion criteria
Patients in whom transnasal endoscopy could not be inserted.
Patients who wish to undergo sedation.
Patients scheduled for endoscopic treatment.
Patients who have undergone surgical resection of the upper gastrointestinal tract (esophagus, stomach, or duodenum).
Patients who are unable to provide written informed consent to participate in this study.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Keitaro |
| Middle name | |
| Last name | TAKAHASHI |
Organization
Asahikawa Medical University
Division name
Gastroenterology
Zip code
078-8510
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
TEL
0166-68-2462
ktakaha@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Keitaro |
| Middle name | |
| Last name | TAKAHASHI |
Organization
Asahikawa Medical University
Division name
Gastroenterology
Zip code
078-8510
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
TEL
0166-68-2462
Homepage URL
ktakaha@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Asahikawa Medical University Research Ethics Committee
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
Tel
0166-68-2297
sho-kenkyu@jimu.asahikawa-med.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
| 2024 | Year | 11 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 23 | Day |
Last modified on
| 2025 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064265
