UMIN-CTR Clinical Trial

Basic information
Public title	A comparison of Parker flex-tip tube and a standard tube for pediatric intubation with the Airwayscope
Acronym	Pediatric Intubation with the AWS
Scientific Title	A comparison of Parker flex-tip tube and a standard tube for pediatric intubation with the Airwayscope
Scientific Title:Acronym	Pediatric Intubation with the AWS
Region	Japan

Condition
Condition	Pediatric patients planned to tracheal intubation
Classification by specialty	Anesthesiology Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In pediatric patients, we compare the ease of intubation tube when intubating using the Airwayscope, which is a type of video laryngoscope.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Seconds from checking glottis with the Airwayscope to intubation
Key secondary outcomes	Seconds until airway scope can be removed Success rate of tracheal intubation Difficulty in passing through the glottis(Evaluated by visual analogue scale) Difficulty in passing through cricoid cartilage(Evaluated by visual analogue scale) Ease of deciding insertion position(Evaluated by visual analogue scale)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Use a Parker tube with a slightly bent tip at the time of tracheal intubation with the Airwayscope.
Interventions/Control_2	Use a marine clot tube used conventionally at the time of tracheal intubation with the Airwayscope.
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	Not applicable
Age-upper limit	2 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients who are scheduled surgery or examination under general anesthesia at Shimane University hospital. 2)Patients who are scheduled to perform tracheal intubation at the surgery or examination. 3)Patients who weigh less than 8 kg at the registration. 4)Patients who are under 2 years old at the registration. 5)Written consent has been obtained by the parents concerning research participation.
Key exclusion criteria	1)Patients who are expected to have difficulty in tracheal intubation. 2)Patients who are expected to have difficulty in mask ventilation. 3)Emergency surgery patients
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Tetsuro Middle name Last name Nikai
Organization	Shimane University Hospital
Division name	Department of intensive care unit
Zip code	693-8501
Address	89-1, Enya-Cho, Izumo city, Shimane prefecture, Japan
TEL	0853-20-2295
Email	tetsunatsu2000@yahoo.co.jp

Public contact
Name of contact person	1st name Tetsuro Middle name Last name Nikai
Organization	Shimane University Hospital
Division name	Department of intensive care unit
Zip code	693-8501
Address	89-1, Enya-Cho, Izumo city, Shimane prefecture, Japan
TEL	0853-20-2295
Homepage URL
Email	tetsunatsu2000@yahoo.co.jp

Sponsor
Institute	Shimane University, faculty of medicine, department of anesthesiology
Institute
Department

Funding Source
Organization	Shimane University, faculty of medicine, department of anesthesiology
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	Institutional review boards at Faculty of Medicine, Shimane University
Address	89-1, Enya-Cho, Izumo city, Shimane prefecture, Japan
Tel	0853-20-2259
Email	kenkyu@med.shimane-u.ac.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	島根大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 25 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	20
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	2017 Year 07 Month 21 Day
Date of IRB	2017 Year 05 Month 16 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 02 Month 19 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 09 Month 08 Day
Last modified on	2020 Year 10 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033233