UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036260 |
|---|---|
| Receipt number | R000041219 |
| Scientific Title | Effects of intraoral reconstructive surgery on based postoperative upper airway patency assessed by apnea hypopnea index (AHI) |
| Date of disclosure of the study information | 2019/03/22 |
| Last modified on | 2022/09/20 13:24:55 |
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Basic information
Public title
Effects of intraoral reconstructive surgery on based postoperative upper airway patency assessed by apnea hypopnea index (AHI)
Acronym
Effects of intraoral reconstructive surgery on based postoperative upper airway patency assessed by apnea hypopnea index (AHI)
Scientific Title
Effects of intraoral reconstructive surgery on based postoperative upper airway patency assessed by apnea hypopnea index (AHI)
Scientific Title:Acronym
Effects of intraoral reconstructive surgery on based postoperative upper airway patency assessed by apnea hypopnea index (AHI)
Region
| Japan |
Condition
Condition
Scheduled intraoral reconstructive surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To that a hypothesis that intraoral reconstructive surgery dry sleep impairs upper airway maintenance function.To explore, mechanisms contribute to increase of apnea hypopnea index, after intraoral reconstructive surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
apnea hypopnea index (AHI)
Key secondary outcomes
Mallampati classification, Otogai thyrotic notch interval, Angle classification to classify occlusion state, overcladding / opening (vertical abnormality), crossing occlusion (horizontal abnormality), Cormack-Lehane (CL) classification, obesity index (BMI), surgical operation, operation time, bleeding volume, CT image.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who accept consent to this study
2. Patients with oral reconstructive surgery
3. Patients not suffering from respiratory infections
4. Patient scheduled to close the stomatal hole after surgery
Key exclusion criteria
1) Patients who can not accept this research
2) Patients already receiving oral reconstructive surgery
3) Patients with permanent tracheostomy
4) Patients who can not close the puncture after surgery
5) Patients suffering from respiratory infection
6) Patients with poor control asthma
7) Patients with epileptic seizures, convulsive seizures
8) Pregnant women
9) Infants, severely handicapped
10) In addition, patients whose research researcher judged unsuitable as subjects
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Fumihiro |
| Middle name | |
| Last name | Yoshikawa |
Organization
Chiba University Hospital
Division name
Anesthesiology, Pain and Palliative Care Medicine
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku Chiba, Japan
TEL
043-222-7171
f.yoshikawa@chiba-u.jp
Public contact
Name of contact person
| 1st name | Fumihiro |
| Middle name | |
| Last name | Yoshikawa |
Organization
Chiba University Hospital
Division name
Anesthesiology, Pain and Palliative Care Medicine
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku Chiba, Japan
TEL
043-222-7171
Homepage URL
f.yoshikawa@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Research ethics committee of the graduate school of medicine, Chiba university
Address
1-8-1 Inohana, Chuo-ku Chiba, Japan
Tel
043-226-2841
igaku-rinri@office.chiba-u.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
千葉大学医学部附属病院／Chiba University Hospital
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 22 | 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
| Delay expected |
Results Delay Reason
Case collection was delayed due to the effects of the new coronavirus.
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
| 2018 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Not implemented
Management information
Registered date
| 2019 | Year | 03 | Month | 19 | Day |
Last modified on
| 2022 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041219
