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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036260
Receipt No. 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 2019/03/19

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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
Email 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
Email f.yoshikawa@chiba-u.jp

Sponsor
Institute Chiba University Hospital
Institute
Department

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
Email 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

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
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
2018 Year 10 Month 17 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 25 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Not implemented

Management information
Registered date
2019 Year 03 Month 19 Day
Last modified on
2019 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041219

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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