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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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ClinicalTrials.gov Identifier: NCT03528590
Recruitment Status : Unknown
Verified April 2018 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : May 18, 2018
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Body Weight Breast Neoplasms Laryngeal Masks Device: size 3 i-gel supraglottic airway device Device: size 4 i-gel supraglottic airway device Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
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
Actual Study Start Date : May 28, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Device: 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.

Experimental: 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.
Device: 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.




Primary Outcome Measures :
  1. 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. [ Time Frame: 1 day ]

    Use ventilation score (1 point for presence of each item, a total score from 0 to 3) to evaluate ventilation efficacy. Ventilation score include:

    1. Air leak pressure below 15 cm H2O
    2. Bilateral chest excursion during inspiratory 20 cm H2O
    3. Square wave capnography


Secondary Outcome Measures :
  1. 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. [ Time Frame: 2 days ]

    Any Side effects include:

    1. Blood stain on i-gel after removing
    2. Sore throat at post-anaesthesia care unit (PACU)
    3. Sore throat after 24 hours
    4. Dysphagia after 24 hours
    5. Mouth, lip and tongue injury
    6. Dysphonia
    7. Hiccup
    8. Myalgia



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528590


Contacts
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Contact: TSUNG AN TSAI, MD 886-2-23123456 ext 62158 na0822@hotmail.com
Contact: Ming Hui Hung, MD 886-2-23123456 ext 62158 hung.minghui@gmail.com

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: TSUNG AN TSAI, MD    886-886-2-23123456 ext 62158    na0822@hotmail.com   
Contact: Ming Hui Hung, MD    886-2-23123456 ext 62158    hung.minghui@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Ming Hui Hung, MD National Taiwan University Hospital Department of Anesthesiology
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03528590    
Other Study ID Numbers: 201803061RIND
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
laryngeal mask airway
breast surgery
Additional relevant MeSH terms:
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Breast Neoplasms
Body Weight
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases