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

NCT03528590 | Unknown

• 1 other identifier: 201803061RIND
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Weight; Breast Neoplasms; Laryngeal Masks

Keywords

laryngeal mask airway; breast surgery

Outcome Measures

Primary Outcomes (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.

  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

  1 day

Secondary Outcomes (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.

  2 days

Study Arms (2)

size 3 i-gel®

ACTIVE COMPARATOR

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

size 4 i-gel®

EXPERIMENTAL

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

Interventions

size 3 i-gel supraglottic airway device DEVICE

Use size 3 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.

size 3 i-gel®

size 4 i-gel supraglottic airway device DEVICE

Use size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.

size 4 i-gel®

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Body Weight; Breast Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ming Hui Hung, MD

  National Taiwan University Hospital Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TSUNG AN TSAI, MD

CONTACT

886-2-23123456; na0822@hotmail.com

Ming Hui Hung, MD

CONTACT

886-2-23123456; hung.minghui@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: May 18, 2018
• Study Start: May 28, 2018
• Primary Completion: March 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 30, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)