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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02260427
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Supraglottic Airway Device	Device: Insertion of the i-gel; Device: Insertion of the air-Q sp	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: the i-gel group After induction of general anesthesia, the i-gel will be inserted according to randomly allocated group.	Device: Insertion of the i-gel; After induction of general anesthesia, the i-gel will be inserted according to randomly allocated group.
Active Comparator: the Air-Q sp group After induction of general anesthesia, the air-Q sp will be inserted according to randomly allocated group.	Device: Insertion of the air-Q sp

Outcome Measures

Primary Outcome Measures

1. airway leak pressure measured after device insertion [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 Outcome Measures

1. insertion parameters (insertion time and ease of insertion) [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. Ease of insertion was graded from 1 to 4.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 90 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University College of Medicine, Gangnam Severance Hospital, 211 Eonju-ro, Gangnam-gu	Seoul		Korea, Republic of	135-720

Sponsors and Collaborators

• Yonsei University

Investigators

• Principal Investigator: Min-Soo Kim, MD, Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research institute, Yonsei University College of Medicine, Seoul

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02260427
• Other Study ID Numbers: 3-2014-0157
• First Posted: Oct 9, 2014
• Last Update Posted: Sep 7, 2016
• Last Verified: Sep 1, 2016

• Keywords provided by Yonsei University: elective surgery; undergoing general anesthesia; elderly adult patients

Study Results

No Results Posted as of Sep 7, 2016