UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of Pentax-AWS Airway Scope and Airtraq for tracheal intubation in patients with obstructive sleep apnoea
Acronym	AWS vs Airtraq for OSA
Scientific Title	Comparison of Pentax-AWS Airway Scope and Airtraq for tracheal intubation in patients with obstructive sleep apnoea
Scientific Title:Acronym	AWS vs Airtraq for OSA
Region	Asia(except Japan)

Condition
Condition	patients, who were diagnosed as having OSA, which was confirmed by polysomnography, but otherwise healthy were recruited into the study
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy of AWS and Airtraq in a single group of patients with OSA.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	intubation difficulty scale score
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	in AWS group, the patient was placed in the sniffing position, and then laryngoscopy and tracheal intubation were performed with Pentax-AWS Airway Scope.
Interventions/Control_2	in Airtraq group, the patient was placed in the sniffing position, and then laryngoscopy and tracheal intubation were performed with Airtraq optic laryngoscope.
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	adult patients (ASA physical status I or II) scheduled for elective uvulopalatopharyngoplasty (UPPP) under general anaesthesia were included in this study.
Key exclusion criteria	1, Patients who had loosened teeth; 2, Patients who had a mouth opening of < 18mm, which is a minimum clearance for the disposable transparent blade; 3, Patients with any pathology in the neck, pharynx or larynx, a risk factor for aspiration of gastric contents; 4, Patients with a history of hypersensitivity to an anaesthetic drug;
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Chen jie
Organization	Third Military Medical University
Division name	Department of Anaesthesiology, Southwest Hospital,
Zip code
Address	Gaotanyan road, Shapingba, Chongqing, China
TEL	+81-086-23-68754197
Email	cjandsh@tmmu.edu.cn

Public contact
Name of contact person	1st name Middle name Last name Chen jie
Organization	Third Military Medical University
Division name	Department of Anaesthesiology, Southwest Hospital,
Zip code
Address	Gaotanyan road, Shapingba, Chongqing, China
TEL	+81-086-23-68754197
Homepage URL
Email	cjandsh@tmmu.edu..cn

Sponsor
Institute	Department of Anaesthesiology, Southwest Hospital,
Institute
Department

Funding Source
Organization	Department of Anaesthesiology, Southwest Hospital,
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 16 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	2015 Year 02 Month 27 Day
Date of IRB
Anticipated trial start date	2015 Year 03 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 03 Month 16 Day
Last modified on	2015 Year 03 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019509

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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