NCT03528590

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Conditions

• Body Weight
• Breast Neoplasms
• Laryngeal Masks

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2018-05-28
• Primary completion: 2019-03-01
• Completion: 2019-05-01
• First posted: 2018-05-18
• Last updated: 2018-05-30

Locations

1 site across 1 country: Taiwan