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

NCT02260427 | Completed

• 1 other identifier: 3-2014-0157
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Supraglottic Airway Device

Keywords

elective surgery; undergoing general anesthesia; elderly 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 after insertion of each device

Secondary Outcomes (1)

• insertion parameters (insertion time and ease of insertion)

  During and 1 min after insertion of each device

Study Arms (2)

the i-gel group

EXPERIMENTAL

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

Device: Insertion of the i-gel

the Air-Q sp group

ACTIVE COMPARATOR

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

Device: Insertion of the air-Q sp

Interventions

Insertion of the i-gel DEVICE

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

the i-gel group

Insertion of the air-Q sp DEVICE

the Air-Q sp group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \. elderly adult patients (65-90 of age) scheduled for elective surgery 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)

Yonsei University College of Medicine, Gangnam Severance Hospital, 211 Eonju-ro, Gangnam-gu

Seoul, Seoul, 135-720, South Korea

Location

Related Publications (1)

• Lee JS, Kim DH, Choi SH, Ha SH, Kim S, Kim MS. Prospective, Randomized Comparison of the i-gel and the Self-Pressurized air-Q Intubating Laryngeal Airway in Elderly Anesthetized Patients. Anesth Analg. 2020 Feb;130(2):480-487. doi: 10.1213/ANE.0000000000003849.

  PMID: 30320644 DERIVED

Study Officials

• Min-Soo Kim, MD

  Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research institute, Yonsei University College of Medicine, Seoul

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 5, 2014
• First Posted: October 9, 2014
• Study Start: September 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 7, 2016

Record last verified: 2016-09

Locations

KR (1)