The Clinical Efficacy of Recently Developed Supraglottic Airway Device, I-gel™, in Neonates and Infants: Comparison With Classic-laryngeal Mask Airway (c-LMA)

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01437137
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arms: 2
• Duration (Months): 16
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

Although the safety and efficacy of the Classic-laryngeal mask airway (c-LMA) in children has been shown in several large observational studies, findings suggest that the smaller-sized c-LMAs, in particular sizes 1 and 1½, are less suitable for airway maintenance under general anesthesia in small infants and that they may even be associated with more frequent complications than with the facemask and endotracheal tube. The pediatric i-gel is a new supraglottic airway device for children. It is made of a soft, gel-like elastomer with a noninflatable cuff. Studies about I-gel in adults have been promising, showing an easy insertion, high airway leak pressures, and low complication rates with few postoperative complaints. The aim of this study is to compare clinical performance of the pediatric i-gel and c-LMA in infants.

Condition or Disease	Intervention/Treatment	Phase
Airway Complication of Anaesthesia	Device: classic-laryngeal mask airway (c-LMA); Device: i-gel™	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: LMA group	Device: classic-laryngeal mask airway (c-LMA); Insertion of c-LMA
Experimental: I-gel group	Device: i-gel™; Insertion of I-gel

Outcome Measures

Primary Outcome Measures

1. airway leak pressure [within 5 min of insertion of each device]

   Airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 40 cmH2O (fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 1 Year
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• infants (0-1 year of age)

• who scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway

Exclusion Criteria:

• patients with an abnormal airway

• with reactive airway disease

• with gastroesophageal reflux disease

• with chronic respiratory disease

• has a history of an upper respiratory tract infection in the preceding 6-week period

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Beylacq L, Bordes M, Semjen F, Cros AM. The I-gel, a single-use supraglottic airway device with a non-inflatable cuff and an esophageal vent: an observational study in children. Acta Anaesthesiol Scand. 2009 Mar;53(3):376-9. doi: 10.1111/j.1399-6576.2008.01869.x.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT01437137
• Other Study ID Numbers: 1-2011-0052
• First Posted: Sep 20, 2011
• Last Update Posted: Jun 4, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Yonsei University: elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway

Study Results

No Results Posted as of Jun 4, 2013