UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019578
Receipt number R000022635
Scientific Title Influences of general anesthesia and lung volume change on upper airway configuration: impact of obesity and obstructive sleep apnea
Date of disclosure of the study information 2015/10/30
Last modified on 2017/05/01 10:34:20

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Basic information

Public title

Influences of general anesthesia and lung volume change on upper airway configuration: impact of obesity and obstructive sleep apnea

Acronym

Influences of muscle paralysis and lung volume on hyoid bone position

Scientific Title

Influences of general anesthesia and lung volume change on upper airway configuration: impact of obesity and obstructive sleep apnea

Scientific Title:Acronym

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

1st name
Middle name
Last name Shiroh Isono

Organization

Graduate School of Medicine, Chiba University

Division name

Department of Anesthesiology

Zip code


Address

1-8-1 Inohana-cho, Chuo-ku, Chiba

TEL

+81432262155

Email

shirohisono@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shiroh Isono

Organization

Graduate School of Medicine, Chiba University

Division name

Department of Anesthesiology

Zip code


Address

1-8-1 Inohana-cho, Chuo-ku, Chiba

TEL

+81432262155

Homepage URL


Email

shirohisono@yahoo.co.jp


Sponsor or person

Institute

Chiba University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Completed

Date of protocol fixation

2015 Year 10 Month 19 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022635


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name