UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004888 |
|---|---|
| Receipt number | R000005722 |
| Scientific Title | Warming igel a new supraglottic airway device shortens time to seal to the larynx? |
| Date of disclosure of the study information | 2011/01/17 |
| Last modified on | 2011/10/27 15:23:59 |
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Basic information
Public title
Warming igel a new supraglottic airway device shortens time to seal to the larynx?
Acronym
Comparison of the igel a new supraglottic airway device with or without warming
Scientific Title
Warming igel a new supraglottic airway device shortens time to seal to the larynx?
Scientific Title:Acronym
Comparison of the igel a new supraglottic airway device with or without warming
Region
| Japan |
Condition
Condition
Diseases which need operation under general anesthesia
Classification by specialty
| Surgery in general | Breast surgery | Orthopedics |
| Urology | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
I-gel TM (Intersurgical Ltd, Wokingham,U.K.) is a new supraglottic airway device, non inflatable mask which is soft, gel like and transparent, made of thermoplastic elastomer. The mask changes its form based on each patient's laryngeal anatomy.The gel to be softened by the patient's temperature, air leakage may occur immediately after insertion of the device. This study is designed to investigate the usefulness of the I-gel which preheated to about body temperature in adults for the airway sealing pressure, inspiratory and expiratory tidal volume , ease of insertion, blood staining of the device, bronchospasm /laryngospasm , regurgitation / aspiration and hoarseness .
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
0,1,2,3,5,10,30and 60 minutes after i-gel insertion
Peak airway pressure
Inspiratory tidal volume
Expiratory tidal volume
Maximam gas leak pressure
ETCO2
SpO2
Key secondary outcomes
Mallampati classification
insertion time
Insertion:
cough,laryngeal spasm,gastric inflation,bleeding
postoperative complications:
nausea,vomiting,hoarseness,sore throat
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
to warm i-gel before using
Interventions/Control_2
control
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA1-3
general anesthetized patients
Key exclusion criteria
full stomach
past history of gastrectomy and surgery of pharynx or larynx
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yumiko Kohno |
Organization
Higashiomiya general hospital
Division name
Anestesiology
Zip code
Address
5-18,Higashiomiya,minuma-ku,Saitama city,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Higashiomiya general hospital
Division name
Anestesiology
Zip code
Address
5-18,Higashiomiya,minuma-ku,Saitama city,Japan
TEL
0486847111
Homepage URL
Sponsor or person
Institute
Higashiomiya general hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Higashiomiya general hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
ASAN Medical Center,Korea
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
東大宮総合病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 17 | 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
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
| 2010 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 17 | Day |
Last modified on
| 2011 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005722
