UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006030 |
|---|---|
| Receipt number | R000007137 |
| Scientific Title | A randomised crossover trial comparing the laryngeal mask ProSeal and the i-gel supraglottic airway |
| Date of disclosure of the study information | 2011/08/01 |
| Last modified on | 2012/07/09 19:59:39 |
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Basic information
Public title
A randomised crossover trial comparing the laryngeal mask ProSeal and the i-gel supraglottic airway
Acronym
Comparison of laryngeal mask ProSeal and i-gel
Scientific Title
A randomised crossover trial comparing the laryngeal mask ProSeal and the i-gel supraglottic airway
Scientific Title:Acronym
Comparison of laryngeal mask ProSeal and i-gel
Region
| Japan |
Condition
Condition
Diseases requiring operation under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of laryngeal mask Proseal and i-gel regarding the ease and time required for insertion, fiberoptic position, hemodynamic changes and leak pressure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Leak pressure
Key secondary outcomes
Ease and time required for insertion and fiberoptic position
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of the laryngeal mask ProSeal
Interventions/Control_2
Use of the i-gel supraglottic airway
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
| 0 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient undergoing elective surgery under general anesthesia
Key exclusion criteria
1. Patients with predicted difficulty in airway management including tracheal intubation
2. Patients undergoing operations in prone position
3. Patients with respiratory complications
4. Patients with a history of abnormal reaction to anesthetics
5. Patients with body weight more than 60 kg
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryu Okutani |
Organization
Osaka City General Hospital and Children's Hospital
Division name
Department of Anesthesiology
Zip code
Address
2-13-22, Miyakojimahondori, Miyakojma-ku, Osaka 534-0021, Japan
TEL
81-6-6929-1221
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryu Okutani |
Organization
Osaka City General Hospital and Children's Hospital
Division name
Department of Anesthesiology
Zip code
Address
2-13-22, Miyakojimahondori, Miyakojma-ku, Osaka 534-0021, Japan
TEL
81-6-6929-1221
Homepage URL
ryu0909@kcat.zaq.ne.jp
Sponsor or person
Institute
Osaka City General Hospital and Children's Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka City General Hospital and Children's Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大阪市立総合医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 01 | 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
Ease of insertion and insertion success rate of the i-gel and the Proseal laryngeal mask airway were comparable, suggesting that both airway devices are able to be safely used in children. Fiberoptic view with the i-gel was better than that with the Proseal laryngeal mask airway.
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
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 23 | Day |
Last modified on
| 2012 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007137
