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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024222
Receipt No. R000027559
Scientific Title Comparison of ability of supraglottic airway(SGA) for children and infants under general anesthesia
Date of disclosure of the study information 2016/09/30
Last modified on 2019/05/28

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Basic information
Public title Comparison of ability of supraglottic airway(SGA) for children and infants under general anesthesia
Acronym Comparison of ability of SGA for children and infants under general anesthesia
Scientific Title Comparison of ability of supraglottic airway(SGA) for children and infants under general anesthesia
Scientific Title:Acronym Comparison of ability of SGA for children and infants under general anesthesia
Region
Japan

Condition
Condition Patient who undergo general anesthesia with SGA
Classification by specialty
Anesthesiology Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate SGA performance in insertion for children and infants
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Sealing Pressure
Key secondary outcomes Insertion Success time, Postoperative pharyngeal pain, hoarseness , Subjective difficulty of insertion, Placement of SGA(bronchoscopic view), complication

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 We insert Ambu Auragain in paitent mouth by standard method from center part, in completely deflated. If there is a resistance, we turn the sevice gently, or chin-up. After the device was detained at the good position, we inflate cuff.
We use Ambu Auragain to ventilate adeqate respiration during surgery. After surgery finished, we stop inhalation anesthesia and remove the Ambu Auragain Spontaneous breathing restart enough.
Interventions/Control_2 We insert i-gel in paitent mouth by standard method from center part, in completely deflated. If there is a resistance, we turn the sevice gently, or chin-up.
We use i-gel to ventilate adeqate respiration during surgery. After surgery finished, we stop inhalation anesthesia and remove the i-gel Spontaneous breathing restart enough.
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
12 years-old >
Gender Male and Female
Key inclusion criteria Patient who undergo general anesthesia with SGA
Key exclusion criteria Emergent operation, Upper respiratory tract infection, Pulmonary disease, Medicalhistory or predictor of difficult airway management, Airway malformation, High risk of gastric regurgitation or vomitting, surgical technique that intubation needs
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Rika
Middle name
Last name Nakayama
Organization Kanagawa childrens medical center
Division name Anesgthesiology
Zip code 2328555
Address 2-138-4Mutsukawa, minami-ku Yokohama city
TEL 045-711-2351
Email rnakayama@kcmc.jp

Public contact
Name of contact person
1st name Rika
Middle name
Last name Nakayama
Organization Kanagawa childrens medical center
Division name Anesgthesiology
Zip code 2328555
Address 2-138-4Mutsukawa, minami-ku Yokohama city
TEL 045-711-2351
Homepage URL
Email rnakayama@kcmc.jp

Sponsor
Institute Kanagawa childrens medical center
Institute
Department

Funding Source
Organization Kanagawa childrens medical center
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 Kanagawa childrens medical center
Address 2-138-4Mutsukawa, minami-ku Yokohama city
Tel 045-711-2351
Email R-nakayama@guitar.ocn.ne.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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 30 Day

Related information
URL releasing protocol UMIN000024222
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/30950904
Number of participants that the trial has enrolled 100
Results
The OLP immediately after insertion was lower for the AuraGain than for the i-gel (17.1 vs. 23.0cmH2O; mean difference: -5.9cmH2O; 95% confidence interval: -8.5 to -3.3cmH2O; P=0.98 and <0.001 for noninferiority and superiority, respectively). The first-attempt success rate (AuraGain, 96% vs. i-gel, 90%; P=0.44) was comparable between the devices. The incidence of blood staining was lower (AuraGain, 6% vs. i-gel, 0%; P=0.012).
Results date posted
2019 Year 05 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patients characteristics were comparable between the groups.
Participant flow
A total of 100 patients were included in this trial. 
Two patients were excluded after randomisation.
Adverse events
The blood staining rate was lower and the time to insertion was shorter in the i-gel than in the AuraGain groups. The incidence of intra-operative airway obstruction was higher in the i-gel group, but the difference was not statistically significant.
Outcome measures
The oropharyngeal leak pressure (noninferiority hypothesis)
The oropharyngeal leak pressure (superiority hypothesis)
Time to insertion
First attempt success rate
Ease of SGA insertion
The incidence of airway obstraction
The ease of gastric tube insertion
Adverse events
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
2016 Year 09 Month 12 Day
Anticipated trial start date
2016 Year 09 Month 12 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 04 Month 05 Day
Date trial data considered complete
2017 Year 06 Month 30 Day
Date analysis concluded
2017 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 29 Day
Last modified on
2019 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027559

Research Plan
Registered date File name
2017/01/25 プロトコール試案98-03.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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