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Ventilation Efficacy of Size 3 or Size 4 I-gel in Female Patient Weighing 50 to 60 Kilograms

Primary Purpose

Body Weight, Breast Neoplasms, Laryngeal Masks

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
size 3 i-gel supraglottic airway device
size 4 i-gel supraglottic airway device
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Body Weight focused on measuring laryngeal mask airway, breast surgery

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 20 years old.
  • ASA physical status I and II.
  • Elective breast surgery.
  • Female with a body weight of 50 - 60 kilograms.

Exclusion Criteria:

  • High risk of aspiration. (defined as history of gastroesophageal reflux, hiatal hernia, previous gastric surgery, and those who take medications for disorders of gastrointestinal motility)
  • 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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

size 3 i-gel®

size 4 i-gel®

Arm Description

size 3 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 in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.

Outcomes

Primary Outcome Measures

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.
Use ventilation score (1 point for presence of each item, a total score from 0 to 3) to evaluate ventilation efficacy. Ventilation score include: Air leak pressure below 15 cm H2O Bilateral chest excursion during inspiratory 20 cm H2O Square wave capnography

Secondary Outcome Measures

Compare side effects of size 3 and size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
Any Side effects include: Blood stain on i-gel after removing Sore throat at post-anaesthesia care unit (PACU) Sore throat after 24 hours Dysphagia after 24 hours Mouth, lip and tongue injury Dysphonia Hiccup Myalgia

Full Information

First Posted
May 7, 2018
Last Updated
May 28, 2018
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03528590
Brief Title
Ventilation Efficacy of Size 3 or Size 4 I-gel in Female Patient Weighing 50 to 60 Kilograms
Official Title
Ventilation Efficacy of I-gel® Size 3 and Size 4 Supraglottic Airway Devices in Anesthetized, Paralyzed Female Patients Weighing Between 50 and 60 Kilograms: a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 28, 2018 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
With the introduction of the laryngeal mask, it has been widely used for the management of airway during general anesthesia. Compared to the endotracheal tube, it has the advantages of easier and faster placing, reducing the proportion of a sore throat and other benefits. The i-gel® is a second-generation of the laryngeal mask. Compared to the classic laryngeal mask, it provides higher sealing pressure and better airway protection to reduce respiratory complications. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight, Breast Neoplasms, Laryngeal Masks
Keywords
laryngeal mask airway, breast surgery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
size 3 i-gel®
Arm Type
Active Comparator
Arm Description
size 3 i-gel supraglottic airway device in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
Arm Title
size 4 i-gel®
Arm Type
Experimental
Arm Description
size 4 i-gel supraglottic airway device in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
Intervention Type
Device
Intervention Name(s)
size 3 i-gel supraglottic airway device
Intervention Description
Use size 3 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
Intervention Type
Device
Intervention Name(s)
size 4 i-gel supraglottic airway device
Intervention Description
Use size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
Primary Outcome Measure Information:
Title
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.
Description
Use ventilation score (1 point for presence of each item, a total score from 0 to 3) to evaluate ventilation efficacy. Ventilation score include: Air leak pressure below 15 cm H2O Bilateral chest excursion during inspiratory 20 cm H2O Square wave capnography
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Compare side effects of size 3 and size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
Description
Any Side effects include: Blood stain on i-gel after removing Sore throat at post-anaesthesia care unit (PACU) Sore throat after 24 hours Dysphagia after 24 hours Mouth, lip and tongue injury Dysphonia Hiccup Myalgia
Time Frame
2 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 20 years old. ASA physical status I and II. Elective breast surgery. Female with a body weight of 50 - 60 kilograms. Exclusion Criteria: High risk of aspiration. (defined as history of gastroesophageal reflux, hiatal hernia, previous gastric surgery, and those who take medications for disorders of gastrointestinal motility) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
TSUNG AN TSAI, MD
Phone
886-2-23123456
Ext
62158
Email
na0822@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Hui Hung, MD
Phone
886-2-23123456
Ext
62158
Email
hung.minghui@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Hui Hung, MD
Organizational Affiliation
National Taiwan University Hospital Department of Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TSUNG AN TSAI, MD
Phone
886-886-2-23123456
Ext
62158
Email
na0822@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ming Hui Hung, MD
Phone
886-2-23123456
Ext
62158
Email
hung.minghui@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Ventilation Efficacy of Size 3 or Size 4 I-gel in Female Patient Weighing 50 to 60 Kilograms

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