Air-Q Intubating Laryngeal Airway Versus the Laryngeal Mask Airway (LMA)-Proseal

NCT01328405 | Completed Phase 4 Results DMC

• 1 other identifier: 2009-0012
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: The air-QⓇ Intubating Laryngeal Airway (ILA) is a newer supraglottic airway. It is approved for use as a primary airway and as an aid for intubation in situations of anticipated or unanticipated difficult airways. A unique feature of this device as compared to other airways on the market is the size of the inner diameter (ID) and length of its airway tube. Direct placement of tracheal tubes \> 7.5 mm ID through the airway tube is possible. The ProSealTM LMA is considered the gold standard for supraglottic devices with respect to airway seal pressure. On average, it is reported to be approximately 28 cmH2O. This is significantly higher than that of the first generation LMA, the LMA-ClassicTM, which has a maximum seal pressure of 20 cmH2O, but averages 16-18 cmH2O in actual practice. In this study the investigators aim to test whether the air-QⓇ creates an airway seal pressure that is similar to the LMA-ProSealTM, whether the position of the air-QⓇ in relation to the vocal cords, as assessed by fiberoptic endoscopy, is similar to that of the LMA-ProSealTM and whether airway morbidity is similar between the air-QⓇ and the LMA-ProSealTM.

Conditions

Difficult Airway; Anesthesia; Functional

Outcome Measures

Primary Outcomes (1)

• Airway Seal Pressure

  The airway seal pressure will then be assessed by closing the APL valve on the anesthesia machine with a fresh gas flow of 5 liters/minute until an audible leak is observed.

  Intraoperative (day 1)

Secondary Outcomes (4)

• Grossly Visible Blood or Bile on LMA

  Upon LMA removal

• Glottic View

  Intraoperative (day 1)

• Airway Pathology

  Postoperative (day 1) in recovery room

• Airway Pathology

  Postoperative Day Two

Study Arms (2)

Air-Q LMA

EXPERIMENTAL

Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)

Device: Laryngeal Mask Airway (LMA)

Proseal LMA

EXPERIMENTAL

LMA-Proseal TM (LMA North America, San Diego, Ca.)

Device: Laryngeal Mask Airway (LMA)

Interventions

Laryngeal Mask Airway (LMA) DEVICE

Comparison of airway seal pressure, airway morbidity bronchoscopic view obtained between two different laryngeal mask airways.

Also known as: Air-QⓇ intubating laryngeal mask(Mercury Medical,Clearwater, Fl.), LMA-Proseal TM(LMA North America,San Diego, Ca.)

Air-Q LMA; Proseal LMA

Eligibility Criteria

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

You may qualify if:

• Patients who are 18 years or greater may be included if they presenting for any elective surgery or procedure to take place in any anesthetic location and require placement of a LMA for their surgery or procedure.

You may not qualify if:

• non-English speaking
• pregnant
• are a minor
• are a prisoner
• have impaired decision-making capacity or any condition for which the primary anesthesia team deems intubation with a tracheal tube to be necessary

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• Cook TM, Lee G, Nolan JP. The ProSeal laryngeal mask airway: a review of the literature. Can J Anaesth. 2005 Aug-Sep;52(7):739-60. doi: 10.1007/BF03016565.

  PMID: 16103390 BACKGROUND

• Wong DT, McGuire GP. Endotracheal intubation through a laryngeal mask/supraglottic airway. Can J Anaesth. 2007 Jun;54(6):489-91; author reply 491. doi: 10.1007/BF03022042. No abstract available.

  PMID: 17541083 BACKGROUND

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Kristopher Schroeder
• Organization: University of Wisconsin School of Medicine and Public Health

kmschro1@wisc.edu

608-263-8100

Study Officials

• Kristopher M Schroeder, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: April 4, 2011
• Study Start: October 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: October 23, 2015
• Results First Posted: August 10, 2012

Record last verified: 2012-07

Locations

US (1)