Comparison of AuraGain With I-gel for Pediatric Patients

General Anesthesia Clinical Trial

Official title:

A Randomized Trial of Ambu® AuraGain™ Versus I-gel® in Young Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03294226
• Other study ID #: S2017-1229
• Status: Completed
• Phase: N/A
• Start date: September 25, 2017
• Est. completion date: March 24, 2018

Study information

• Verified date: May 2018
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Children from 6 months to 6 years are randomly allocated into AuraGain group or I-gel group. After anesthetic induction without neuromuscular blocking agent, assigned device in inserted by skillful anesthesiologist. The outcome measures are recorded and analysed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 24, 2018
• Est. primary completion date: March 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 6 Years

Eligibility

Inclusion Criteria:

• ASA physical status: 1-3

• age: from 6 months to 6 year

• body weight: 5-20kg

• patients undergoing upper/lower extremity surgery at supine position

Exclusion Criteria:

• patients who do not want to participate in this study

• patients with known difficult airway including congenital facial anomaly or history of difficult airway management

• patients with aspiration risk (gastrointestinal stenosis or stricture)

• patients with symptom of upper respiratory infection on the day of surgery

• patients scheduled for day surgery

• patients judged as not eligible by researchers for other reasons

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Device:
• AuraGain
After anesthetic induction without neuromuscular blocking agent, AuraGain is inserted.
• I-gel
After anesthetic induction without neuromuscular blocking agent, I-gel is inserted.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	requirement of additional airway maneuver	including adjustment of head/neck position or insertion depth and taping of the device	during placement/maintenance of the device
Secondary	insertion time		during placement of the device
Secondary	success rate		during placement of the device
Secondary	ease of gastric tube insertion		within 10 minutes after device insertion
Secondary	adverse effect at operating room	aspiration of gastric fluid, hypoxia, SpO2<90%, bronchospasm, dental/tongue/lip trauma, staining of blood on the removed device	during anesthesia
Secondary	postoperative adverse effect	sore throat, hoarseness, airway obstruction	within postoperative 24 hours
Secondary	fiberoptic view of glottis	Brimacombe score	within 10 minutes after device insertion
Secondary	oropharyngeal leak pressure		at 1 minute after device insertion, at 10 minutes after device insertion