A Comparison of the I-gel and Self-pressurised Air-Q Intubating Laryngeal Airway (Air-Q sp) in the Elderly Patients

Not Applicable

Completed

• Conditions: Supraglottic Airway Device
• Interventions: Device: Insertion of the i-gel; Device: Insertion of the air-Q sp

• Registration Number: NCT02260427
• Lead Sponsor: Yonsei University

Brief Summary

Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these devices, the i-gel has been typically widely used. The self-pressurised air-Q intubating laryngeal airway (air-Q sp) is newly developed supraglottic airway devices. It is a new single-use device that may optimise the airway sealing while reducing the potential for postoperative complications such as sore throat. The overall structure of the air-Q sp is similar to the original air-Q, except the inflatable cuff. The aim of this randomized trial was to compare the clinical performance of the i-gel and the air-Q sp in elderly patients

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-10-05
• Study First Submitted QC: 2014-10-08
• Study First Posted: 2014-10-09
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-05
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. elderly adult patients (65-90 of age) scheduled for elective surgery undergoing general anesthesia using supraglottic airway

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Exclusion Criteria

1. Patients with a potentially difficult airway, risk of aspiration such as gastroesophageal reflux disease, or active upper respiratory tract infection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the i-gel group	Insertion of the i-gel	After induction of general anesthesia, the i-gel will be inserted according to randomly allocated group.
the Air-Q sp group	Insertion of the air-Q sp	After induction of general anesthesia, the air-Q sp will be inserted according to randomly allocated group.

Primary Outcome Measures

Name	Time	Method
airway leak pressure measured after device insertion	within 5min after 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.

Secondary Outcome Measures

Name	Time	Method
insertion parameters (insertion time and ease of insertion)	During and 1 min after insertion of each device	Insertion time was defined as the time from the attending anesthesiologist picking up the LMA until the confirmation on capnography. Ease of insertion was graded from 1 to 4.

Trial Locations

Locations (1)

Yonsei University College of Medicine, Gangnam Severance Hospital, 211 Eonju-ro, Gangnam-gu; 🇰🇷 Seoul, Korea, Republic of