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)

NCT02206438 | Completed DMC

• 1 other identifier: 3-2014-0081
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

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

Outcome Measures

Primary Outcomes (1)

• airway leak pressure measured after device insertion

  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.

  within 5min to 10 min insertion of each device

Secondary Outcomes (1)

• Insertion time

  During and 1 min after insertion of each device

Other Outcomes (1)

• Ease of insertion

  During and 1 min after insertion of each device

Study Arms (2)

1)C-LMA group

EXPERIMENTAL

Device: Insertion of C-LMA

2)Air-Q group

ACTIVE COMPARATOR

Device: Insertion of air-Q according

Interventions

Insertion of C-LMA DEVICE

After induction of general anesthesia, C-LMA or Air-Q was inserted according to randomly allocated group.

1)C-LMA group

Insertion of air-Q according DEVICE

After induction of general anesthesia, C-LMA or Air-Q was inserted according to randomly allocated group.

2)Air-Q group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Human research Protection Center, Gangnam Severance Hospital,

Seoul, 120-752, South Korea

Location

Related Publications (1)

• Ha SH, Kim MS, Suh J, Lee JS. Self-pressurized air-Q(R) intubating laryngeal airway versus the LMA(R) Classic: a randomized clinical trial. Can J Anaesth. 2018 May;65(5):543-550. doi: 10.1007/s12630-018-1082-6. Epub 2018 Feb 6.

  PMID: 29524199 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: August 1, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: January 11, 2019

Record last verified: 2016-10

Locations

KR (1)