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)

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02206438
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 10.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery	Device: Insertion of C-LMA; Device: Insertion of air-Q according	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Other
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1)C-LMA group	Device: Insertion of C-LMA; After induction of general anesthesia, C-LMA or Air-Q was inserted according to randomly allocated group.
Active Comparator: 2)Air-Q group	Device: Insertion of air-Q according; After induction of general anesthesia, C-LMA or Air-Q was inserted according to randomly allocated group.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Other Outcome Measures

1. Ease of insertion [During and 1 min after insertion of each device]

   Ease of insertion was graded from 1 to 4.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Human research Protection Center, Gangnam Severance Hospital,	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02206438
• Other Study ID Numbers: 3-2014-0081
• First Posted: Aug 1, 2014
• Last Update Posted: Jan 11, 2019
• Last Verified: Oct 1, 2016

• Keywords provided by Yonsei University: supraglottic airway devices; the classic laryngeal mask airway; the self-pressurised air-Q intubating laryngeal airway in adult patients; elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway in adult patients

Study Results

No Results Posted as of Jan 11, 2019