Air-Q® SP Versus Air-Q® and I-gel: A Randomized Clinical Trial

NCT01592760 | Completed Results

• 1 other identifier: 2011-0805
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

The air-Q Self-Pressurizing Intubating Laryngeal Airway (aILA SP) is a modification of the air-Q Intubating Laryngeal Airway (aILA). Besides the i-gel, it is the only breathing tube that sits above the vocal cords that does not require inflation of a cuff with air. The purpose of this study is to compare the ability of the aILA-SP to maintain patency of a patient's airway during general anesthesia with that of the aILA and i-gel devices. As a measure of this ability, we hypothesized that the airway sealing pressures will be equal between the aILA-SP and aILA, but superior when comparing the aILA-SP to the i-gel (i-gel will be lower).

Conditions

Laryngeal Masks

Keywords

air-Q SP; air-Q; i-gel; supraglottic airway device; laryngeal mask airway

Outcome Measures

Primary Outcomes (1)

• Airway Seal Pressure After Device Placement

  Airway seal pressure is defined as the pressure in cmH2O at which the needle of a manometer attached to the anesthesia circuit reaches equilibration, associated with an audible air leak from the subject's oropharynx or gastric insufflation, limited to a maximum pressure of 40 cmH2O. It is measured with the subject's head and neck in neutral position, the expiratory valve on the anesthesia machine closed, and the fresh gas flow set to five liters per minute.

  Measured within 5 minutes after device placement/study initiation

Secondary Outcomes (11)

• Device Placement Time

  Measured at device placement/study initiation

• Device Placement Success Rate

  Measured at the time of attempted study device placement immediately after the induction of general anesthesia

• Device Ease of Insertion

  Reported by the device operator at the time successful device placement is recorded.

• Device Position in Relation to the Vocal Cords

  Measured within 5 minutes of successful study device placement

• Device Use Time (Min)

  Measured between successful device placement and device removal for any reason, approximately 2 hours

Study Arms (3)

air-Q SP

EXPERIMENTAL

air-Q Self-Pressurizing Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)

Device: air-Q SP

air-Q

ACTIVE COMPARATOR

air-Q Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)

Device: air-Q

i-gel

ACTIVE COMPARATOR

i-gel, sizes 3, 4, and 5 (Intersurgical Inc., Liverpool, NY, USA)

Device: i-gel

Interventions

air-Q SP DEVICE

air-Q SP placement for airway maintenance.

air-Q SP

air-Q DEVICE

air-Q placement for airway maintenance.

air-Q

i-gel DEVICE

i-gel placement for airway maintenance.

i-gel

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years;
• scheduled for an elective surgery or procedure; and
• general anesthesia with placement of a SGA planned.

You may not qualify if:

• \< 18 years of age;
• non-English speaking;
• known or believed to be pregnant;
• prisoner;
• has impaired decision-making capacity;
• has symptomatic untreated gastroesophageal reflux;
• has had a prior esophagectomy;
• has a known or suspected hiatal hernia;
• has vomited within twenty-four hours of the surgery or procedure;
• has known oral pathology making a proper SGA fit unlikely; or
• has any condition for which the primary anesthesia care team deems intubation with a tracheal tube to be necessary.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• Galgon RE, Schroeder KM, Han S, Andrei A, Joffe AM. The air-Q((R)) intubating laryngeal airway vs the LMA-ProSeal(TM) : a prospective, randomised trial of airway seal pressure. Anaesthesia. 2011 Dec;66(12):1093-100. doi: 10.1111/j.1365-2044.2011.06863.x. Epub 2011 Aug 22.

  PMID: 21880031 BACKGROUND

Results Point of Contact

• Title: Richard E. Galgon, MD, MS
• Organization: Universtiy of Wisconsin School of Medicine and Public Health

galgon@wisc.edu

608-263-8100

Study Officials

• Richard E Galgon, MD, MS

  Department of Anesthesiology, University of Wisconsin School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: May 2, 2012
• First Posted: May 7, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 17, 2017
• Results First Posted: February 8, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)