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Clinical Trials/NCT02260427
NCT02260427
Completed
Not Applicable

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

Yonsei University1 site in 1 country100 target enrollmentSeptember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Supraglottic Airway Device
Sponsor
Yonsei University
Enrollment
100
Locations
1
Primary Endpoint
airway leak pressure measured after device insertion
Status
Completed
Last Updated
9 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
August 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

airway leak pressure measured after device insertion

Time Frame: 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 Outcomes

  • insertion parameters (insertion time and ease of insertion)(During and 1 min after insertion of each device)

Study Sites (1)

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