UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004888
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Higashiomiya general hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005722

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.