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

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03528590
• Other study ID #: 201803061RIND
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2018
• Est. completion date: May 2019

Study information

• Verified date: April 2018
• Source: National Taiwan University Hospital
• Contact: TSUNG AN TSAI, MD
• Phone: 886-2-23123456
• Email: na0822[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: May 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Breast Neoplasms
• Laryngeal Masks

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 day
Secondary	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	2 days