Ventilation Efficacy of Size 3 or Size 4 I-gel in Female Patient Weighing 50 to 60 Kilograms
NCT ID: NCT03528590
Last Updated: 2018-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
98 participants
INTERVENTIONAL
2018-05-28
2019-05-31
Brief Summary
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Detailed Description
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Choosing an appropriate size laryngeal mask is an important issue. Trauma during placing or positive ventilation failure may occur if the wrong size is selected. Currently, the main method for selecting an i-gel® size is based on the body weight recommendation (30-60 kg for size 3 and 50-90 kg for size 4) according to the manufacturer's recommendation. However, there is an overlapping in size selection in people weighing between 50 and 60 kilograms. Laryngeal mask airways are widely used for breast surgery, and this patient cohort is often weighed between 50-60 kilograms in National Taiwan University Hospital. Therefore, in this randomized clinical trial, the investigators will compare the ventilation efficacy of size 3 and size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. Also, the investigators will record any side effects of size 3 and size 4 i-gel® in this cohort.
Keywords: Airway management; laryngeal mask airway; breast surgery
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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size 3 i-gel®
size 3 i-gel supraglottic airway device in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
size 3 i-gel supraglottic airway device
Use size 3 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
size 4 i-gel®
size 4 i-gel supraglottic airway device in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
size 4 i-gel supraglottic airway device
Use size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
Interventions
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size 3 i-gel supraglottic airway device
Use size 3 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
size 4 i-gel supraglottic airway device
Use size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
Eligibility Criteria
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Inclusion Criteria
* ASA physical status I and II.
* Elective breast surgery.
* Female with a body weight of 50 - 60 kilograms.
Exclusion Criteria
* Previous head \& neck surgery.
* Previous head \& neck concurrent chemoradiotherapy (CCRT)
* Reactive airway disease: chronic obstructive pulmonary disease (COPD), asthma, upper respiratory infection in recent two weeks
* Exposure to tobacco
* Pregnancy
20 Years
FEMALE
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Ming Hui Hung, MD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital Department of Anesthesiology
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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201803061RIND
Identifier Type: -
Identifier Source: org_study_id
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