UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000031531
Receipt No. R000028847
Official scientific title of the study The clinical evaluation of insertion depth of pediatric i-gel based on fiberoptic view and leak pressure: should the i-gel be deeply inserted or not
Date of disclosure of the study information 2018/03/01
Last modified on 2018/03/01 (Ver. 2)

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Basic information
Official scientific title of the study The clinical evaluation of insertion depth of pediatric i-gel based on fiberoptic view and leak pressure: should the i-gel be deeply inserted or not
Title of the study (Brief title) The clinical evaluation of insertion depth of pediatric i-gel
Region
Japan

Condition
Condition pediatric surgery
plastic surgery
Classification by specialty
Anesthesiology Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study was to investigate whether i-gel should be inserted until resistance is felt or let it slide out, including leak pressure and fiberoptic view.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes leak pressure
Key secondary outcomes insertion depth

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
1 years-old <=
Age-upper limit
8 years-old >=
Gender Male and Female
Key inclusion criteria Children who received general anesthesia
10kg<Body weight<25kg
Key exclusion criteria Children who have airway problem
Target sample size 100

Research contact person
Name of lead principal investigator Jun Yoshino
Organization St. Mary's Hospital
Division name Department of Anesthesia
Address 422 Tsubukuhonmachi, Kurume, Fukuoka
TEL 0942-35-3322
Email j-yoshino@st-mary-med.or.jp

Public contact
Name of contact person Yosie Naito
Organization St. Mary's Hospital
Division name institute of clinical, education and research
Address 422 Tsubukuhonmachi, Kurume, Fukuoka
TEL 0942-35-3322
Homepage URL
Email naito-yoshie@st-mary-med.or.jp

Sponsor
Institute St. Mary's Hospital
Institute
Department

Funding Source
Organization St. Mary's Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 01 Day

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 06 Month 15 Day
Anticipated trial start date
2016 Year 07 Month 11 Day
Last follow-up date
2018 Year 02 Month 09 Day
Date of closure to data entry
2018 Year 02 Month 09 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information The aim of the current study was to evaluate which i-jel position is better for the secure fixation in pediatric patients, including where the operator feels some resistance during the insertion (position A) or the device is allowed to emerge from the oral cavity after the position A (position B). Accordingly, we investigated the appropriate insertion depth, leak pressure, and fiberoptic view of the epiglottis in the two positions when using the i-gel (size #2) in pediatric surgical patients.

Management information
Registered date
2018 Year 03 Month 01 Day
Last modified on
2018 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028847