UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influences of general anesthesia and lung volume change on upper airway configuration: impact of obesity and obstructive sleep apnea
Title of the study (Brief title)	Influences of muscle paralysis and lung volume on hyoid bone position
Region	Japan

Condition
Condition	Adult Patients undergoing general anesthesia
Classification by specialty	Pneumology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To test hypotheses that 1) induction of general anesthesia results in cranial shift of the hyoid bone particularly in patients with obstructive sleep apnea, 2)lung volume increase during general anesthesia results in cranial shift of the hyoid bone particularly in obese obstructive sleep apnea patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	hyoid bone position
Key secondary outcomes	craniofacial dimensions, patient characteristics, severity of obstructive sleep apnea, obesity

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	head and neck radiography and lung volume increase
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	40 years-old <=
Age-upper limit	70 years-old >=
Gender	Male
Key inclusion criteria	1. General anesthesia is scheduled for the surgery. 2. Adult male who is older than or equal to 40 years old and younger than or equal to 70 years old.
Key exclusion criteria	1. Patients American Society of Anesthesiologists Physical Status greater than 3 2. Patients with upper airway abnormalities. 3. Patients with severe COPD. 4. Patients with uncontrolled asthma. 5. Patients with aonea hypopnea index between 10 and 15
Target sample size	66

Research contact person
Name of lead principal investigator	Shiroh Isono
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Anesthesiology
Address	1-8-1 Inohana-cho, Chuo-ku, Chiba
TEL	+81432262155
Email	shirohisono@yahoo.co.jp

Public contact
Name of contact person	Shiroh Isono
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Anesthesiology
Address	1-8-1 Inohana-cho, Chuo-ku, Chiba
TEL	+81432262155
Homepage URL
Email	shirohisono@yahoo.co.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Japanese Grants-in-Aid for Scientific Research (Kakenhi)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	Chiba University Hospital

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 19 Day
Anticipated trial start date	2015 Year 11 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2017 Year 04 Month 28 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 10 Month 30 Day
Last modified on	2017 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022635