The Clinical Efficacy of Supraglottic Airway Device, Self-pressurized Air-Q Intubating Laryngeal Airway (ILA -SP) in Adult Patients: Comparison With Classic-laryngeal Airway (c-LMA)

Not Applicable

Completed

• Conditions: Surgery
• Interventions: Device: Insertion of C-LMA; Device: Insertion of air-Q according

• Registration Number: NCT02206438
• Lead Sponsor: Yonsei University

Brief Summary

Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these devices ,classic laryngeal airway has been typically widely used. The self-pressurised air-Q (air-Q) 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 identical to the original air-Q, except with regard to the inflatable cuff. The aim of this randomized trial was to compare the clinical performance of the classic LMA and the air-Q SP.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-08-01
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-10
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Adult patients (20-75 of age) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway

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Exclusion Criteria

• 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
1)C-LMA group	Insertion of C-LMA	-
2)Air-Q group	Insertion of air-Q according	-

Primary Outcome Measures

Name	Time	Method
airway leak pressure measured after device insertion	within 5min to 10 min 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 time	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.

Trial Locations

Locations (1)

Human research Protection Center, Gangnam Severance Hospital,; 🇰🇷 Seoul, Korea, Republic of