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Clinical Trials/NCT02206438
NCT02206438
Completed
Not Applicable

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)

Yonsei University1 site in 1 country84 target enrollmentJuly 2014
ConditionsSurgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery
Sponsor
Yonsei University
Enrollment
84
Locations
1
Primary Endpoint
airway leak pressure measured after device insertion
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
March 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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 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 Outcomes

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

Study Sites (1)

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