UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055510 |
|---|---|
| Receipt number | R000063432 |
| Scientific Title | To study the effect of suppressing hypopnea during sedation by delivering oxygen through a small-diameter tube inserted through the nose into the pharynx. |
| Date of disclosure of the study information | 2024/09/20 |
| Last modified on | 2024/09/16 14:37:33 |
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Basic information
Public title
To study the effect of suppressing hypopnea during sedation by delivering oxygen through a small-diameter tube inserted through the nose into the pharynx.
Acronym
To study the effect of suppressing hypopnea during sedation by delivering oxygen through a small-diameter tube inserted through the nose into the pharynx.
Scientific Title
To study the effect of suppressing hypopnea during sedation by delivering oxygen through a small-diameter tube inserted through the nose into the pharynx.
Scientific Title:Acronym
To study the effect of suppressing hypopnea during sedation by delivering oxygen through a small-diameter tube inserted through the nose into the pharynx.
Region
| Japan |
Condition
Condition
Sedation for prostate biopsy
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Prostate biopsy requires deep sedation. Middle-aged men with obstructive sleep apnea are prone to hypopnea due to upper airway obstruction during sedation. In our previous study, sedation with pentazocine and propofol resulted in 0 cases requiring mask ventilation. However, in 30% of cases, a nasal airway was necessary to avoid hypopnea due to upper airway obstruction during sedation. (UMIN000051953) The available nasal airways are thick, can cause coughing and body movements, and their shape does not allow for oxygen administration. Therefore, the use of a smaller diameter and oxygenatable device may reduce upper airway obstruction and decrease hypopnea. The purpose of this study is to test the following hypothesis.
Hypothesis: Continuous oxygenation through a small intubation tube inserted into the nasopharynx will decrease hypopnea time and reduce the rate of nasal airway use.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hypopnea time during sedation
Key secondary outcomes
SpO2
Frequency of Nasal airway use during sedation
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male
Key inclusion criteria
Patients undergoing prostate biopsy with deep sedation
Key exclusion criteria
Patients without obstructiove sleep apnea
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | |
| Last name | Yamamura |
Organization
Showa University Northern Yokohama Hospital
Division name
Department of anesthesiology
Zip code
224-8503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
TEL
045-949-7000
ayayamamura128@gmail.com
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Yamamura |
Organization
Showa University Northern Yokohama Hospital
Division name
Department of anesthesiology
Zip code
224-8503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
TEL
045-949-7000
Homepage URL
ayayamamura128@gmail.com
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Research Ethics Review Board
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8000
m-rinri@ofc.showa-u.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 | 09 | Month | 20 | 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
| 2024 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To determine whether administration of low-flow oxygen through a small-diameter intubation tube inserted nasally into the pharyngeal cavity can prevent upper airway obstruction and decrease hypopnea time caused by upper airway obstruction. Oxygen flow rate, hypopnea time, and SpO2 required during sedation will be studied.
Management information
Registered date
| 2024 | Year | 09 | Month | 16 | Day |
Last modified on
| 2024 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063432
