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Clinical Trials/NCT02260427
NCT02260427CompletedNot 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 enrollmentStarted: September 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
airway leak pressure measured after device insertion

Study 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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to 90 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

the i-gel group

Experimental

After induction of general anesthesia, the i-gel will be inserted according to randomly allocated group.

Intervention: Insertion of the i-gel (Device)

the Air-Q sp group

Active Comparator

After induction of general anesthesia, the air-Q sp will be inserted according to randomly allocated group.

Intervention: Insertion of the air-Q sp (Device)

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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