UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029068
Receipt No. R000033233
Scientific Title A comparison of Parker flex-tip tube and a standard tube for pediatric intubation with the Airwayscope
Date of disclosure of the study information 2017/09/25
Last modified on 2019/04/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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
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
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 08 Day
Last modified on
2019 Year 04 Month 16 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.