UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The time-dependent change of leak pressure of i-gel in children
Title of the study (Brief title)	The time-dependent change of leak pressure of i-gel in children
Region	Japan

Condition
Condition	pediatric patients considered suitable for general anesthesia with i-gel
Classification by specialty	Operative medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to investigate the time-dependant change of i-gel in children
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	leak pressure
Key secondary outcomes	bronchoscopic view of the larynx, ease of insertion, number of insertion attempts, complications occurring during insertion

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	3 months-old <=
Age-upper limit	72 months-old >=
Gender	Male and Female
Key inclusion criteria	ASA-PS 1 or 2, <3 hrs of proposed operation, supine position, patients for whom anesthetic management using gel size 1.5 or 2 is planed
Key exclusion criteria	emergent surgery, patients with high risk of aspiration, patients with difficult airway, patients with congenital deformation of airway, patients with cervical spine disease, patients with symptom of airway infection, patients with sever respiratory/cardiovascular disease
Target sample size	36

Research contact person
Name of lead principal investigator	Hirata Naoyuki
Organization	Sapporo Medical University
Division name	Department of Anesthesiology
Address	south 1 west 16 chuo-ku sapporo
TEL	011-611-2111
Email	naohirata@mac.com

Public contact
Name of contact person	Yoshikawa Yusuke
Organization	Sapporo Medical University
Division name	Department of Anesthesiology
Address	south 1 west 16 chuo-ku sapporo
TEL	011-611-2111
Homepage URL
Email	yusuke_19_@hotmail.com

Sponsor
Institute	Department of Anesthesiology, Sapporo Medical University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Anesthesiology, Hokkaido Medical Center for Child Health and Rehabilitation
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	札幌医科大学附属病院（北海道）、北海道立子ども総合医療・療育センター（北海道）

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 31 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 01 Month 14 Day
Anticipated trial start date	2014 Year 01 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Primary outcome and secondary outcomes are assessed during general anesthesia with i-gel

Management information
Registered date	2014 Year 01 Month 30 Day
Last modified on	2018 Year 01 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015203