UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053915 |
|---|---|
| Receipt number | R000061545 |
| Scientific Title | Analysis of oxygen concentration in the oral cavity during intravenous sedation with intranasal oxygen administration for dental treatment |
| Date of disclosure of the study information | 2024/03/20 |
| Last modified on | 2024/03/20 17:54:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Analysis of oxygen concentration in the oral cavity during intravenous sedation with intranasal oxygen administration for dental treatment
Acronym
Analysis of oxygen concentration in the oral cavity during intravenous sedation with intranasal oxygen administration for dental treatment
Scientific Title
Analysis of oxygen concentration in the oral cavity during intravenous sedation with intranasal oxygen administration for dental treatment
Scientific Title:Acronym
Analysis of oxygen concentration in the oral cavity during intravenous sedation with intranasal oxygen administration for dental treatment
Region
| Japan |
Condition
Condition
Dental Phobia
Classification by specialty
| Anesthesiology | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
When high-concentration oxygen is stored in the oral cavity and it catches fire, a severe medical accident, such as airway burn, may occur. From the viewpoint of medical safety management for dental treatment, this study aimed to clarify the changes in oxygen concentration under intravenous sedation with oxygen and propofol administration when using a nasal cannula.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Oxygen concentration of the oral cavity under intravenous sedation
Key secondary outcomes
Mean blood pressure, pulse rate, and sedation level
Oxygen concentration of the oral cavity with mouth prop under intravenous sedation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
After achieving a steady state of cardiovascular parameters, the participants were sedated with a continuous propofol infusion dose of 6 mg/kg/hr for 25 min, and oxygen was administered at a rate of 3 L/min via a nasal cannula.
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
| 24 | years-old | <= |
Age-upper limit
| 39 | years-old | > |
Gender
Male
Key inclusion criteria
Participants were categorized according to the American Society of Anesthesiologists physical status 1.
Key exclusion criteria
Exclusion criteria were subject except for Anesthesiologists physical status 1.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroyoshi |
| Middle name | |
| Last name | Kawaai |
Organization
Ohu University School of Dentistry
Division name
Department of Oral Function and Molecular Biology
Zip code
963-8611
Address
31-1 Misumido, Tomita, Koriyama, Fukushima
TEL
0249329337
maromaro@ce.mbn.or.jp
Public contact
Name of contact person
| 1st name | Hiroyoshi |
| Middle name | |
| Last name | Kawaai |
Organization
Ohu University School of Dentistry
Division name
Department of Oral Function and Molecular Biology
Zip code
963-8611
Address
31-1 Misumido, Tomita, Koriyama, Fukushima
TEL
0249328931
Homepage URL
maromaro@ce.mbn.or.jp
Sponsor or person
Institute
Ohu University
Institute
Department
Personal name
Funding Source
Organization
Department of Oral Function and Molecular Biology, School of Dentistry, Ohu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Ohu University
Address
31-1 Misumido, Tomita, Koriyama, Fukushima
Tel
0249328931
h-kawai@den.ohu-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
奥羽大学歯学部附属病院（福島県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
19
Results
Compared with the control, the oxygen concentration in the MMSP (Median Maxillary Anterior Teeth) increased significantly at each time point, and the oxygen concentration in the MMAT (Median Maxillary Soft Palate) increased significantly at 20-23 min. Moreover, based on the comparison of before and after the use of a mouth prop, the oxygen concentration showed an upward trend, without any statistically significant differences between the two time points in both MMAT and MMSP.
Results date posted
| 2024 | Year | 03 | Month | 20 | Day |
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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | 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 | 03 | Month | 20 | Day |
Last modified on
| 2024 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061545
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
