UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024222 |
|---|---|
| Receipt number | 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 20:37:43 |
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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
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
rnakayama@kcmc.jp
Sponsor or person
Institute
Kanagawa childrens medical center
Institute
Department
Personal name
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
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
Value
https://center6.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 |
