UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047007 |
|---|---|
| Receipt number | R000053636 |
| Scientific Title | Development of respiratory monitoring method using ultra-sensitive smart piezoelectric vibration sensor (AYA-P) in the perioperative period |
| Date of disclosure of the study information | 2022/02/28 |
| Last modified on | 2022/02/25 21:04:36 |
* 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
Development of respiratory monitoring method using ultra-sensitive smart piezoelectric vibration sensor (AYA-P) in the perioperative period
Acronym
Development of respiratory monitoring method using ultra-sensitive smart piezoelectric vibration sensor (AYA-P) in the perioperative period
Scientific Title
Development of respiratory monitoring method using ultra-sensitive smart piezoelectric vibration sensor (AYA-P) in the perioperative period
Scientific Title:Acronym
Development of respiratory monitoring method using ultra-sensitive smart piezoelectric vibration sensor (AYA-P) in the perioperative period
Region
| Japan |
Condition
Condition
dental phobia
severe gag reflex
Classification by specialty
| Anesthesiology | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
During the recovery period after general anesthesia and during intravenous sedation management, it is common for the effects of anesthetics to suppress breathing. Ventilation problems due to airway obstruction can occur in situations where there is no reliable airway management. Since airway obstruction inhibits the uptake of oxygen into the body and is harmful to the patient, it is important to be aware of and respond to the event of airway obstruction at an early stage. Therefore, the purpose is to develop a respiratory monitoring method using an ultra-sensitive smart piezoelectric vibration sensor (AYA-P) as a simple and reliable respiratory monitoring method that detects airway obstruction at an early stage.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vibration velocity data
Key secondary outcomes
SpO2
EtCO2
chest movement
Breath sounds
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the patients with dental phobia or gag reflex who need dental treatment under intravenous sedation
the patients under general anesthesia
volunteer
Key exclusion criteria
When we can not obtain the consent to study of patients and their family
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Saori |
| Middle name | |
| Last name | Takagi |
Organization
Meikai University School of Dentistry
Division name
Division of Dental Anesthesiology, Department of Diagnostic and Therapeutic Sciences
Zip code
350-0283
Address
1-1 Keyakidai, Sakado-shi, Saitama, Japan
TEL
0492792738
sogami@dent.meikai.ac.jp
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Takagi |
Organization
Meikai University School of Dentistry
Division name
Division of Dental Anesthesiology, Department of Diagnostic and Therapeutic Sciences
Zip code
350-0283
Address
1-1 Keyakidai, Sakado-shi, Saitama, Japan
TEL
0492792738
Homepage URL
sogami@dent.meikai.ac.jp
Sponsor or person
Institute
Meikai University School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Meikai University School of Dentistry
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
Meikai University School of Dentistry
Address
1-1 Keyakidai, Sakado-shi, Saitama, Japan
Tel
0492792738
sogami@dent.meikai.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
| 2022 | Year | 02 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
SpO2
EtCO2
chest movement
breath sounds
Vibration velocity data
Management information
Registered date
| 2022 | Year | 02 | Month | 25 | Day |
Last modified on
| 2022 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053636
