Air-Q® SP Versus Air-Q® and I-gel

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Wisconsin, Madison
Sponsor:
Information provided by (Responsible Party):
Richard Galgon, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01592760
First received: May 2, 2012
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention
Laryngeal Masks
Device: air-Q SP
Device: air-Q
Device: i-gel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Air-Q® Self-Pressurizing (SP) Intubating Laryngeal Airway With the Air-Q® Intubating Laryngeal Airway and I-gel for Airway Maintenance in Adults Under General Anesthesia

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Airway seal pressure after device placement [ Time Frame: Measured within 5 minutes after device placement/study initiation ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Device placement time [ Time Frame: Measured at device placement/study initiation ] [ Designated as safety issue: No ]
    Device placement time is the time measured in seconds from when the study investigator picks up the airway device to confirmation of ventilation by the presence of an adequate end-tidal carbon dioxide tracing on the monitor.

  • Device placement success rate [ Time Frame: Measured at device placement/study initiation ] [ Designated as safety issue: No ]
    Device placement success rate is defined as the proportion of devices successfully placed within three attempts at device placement.

  • Device ease of insertion [ Time Frame: Reported by the device operator at the time of device placement/study initiation ] [ Designated as safety issue: No ]
    Device ease of insertion is graded as either easy, slightly difficult, difficult, or impossible.

  • Device position in relation to the vocal cords [ Time Frame: Measured within 5 minutes of device placement/study initiation ] [ Designated as safety issue: No ]
    Device position in relation to the vocal cords is assessed with a flexible fiberoptic camera and graded as follows: 1 = full view of the vocal cords, 2 = partial view of the vocal cords including the arytenoids, 3 = view of the epiglottis only, and 4 = other (device cuff, pharynx or other structures).

  • Incidence of gastric insufflation [ Time Frame: Measured within 5 minutes of device placement/study initiation ] [ Designated as safety issue: Yes ]
    Gastric insufflation is present when audible air sounds are heard by stethoscope over the subject's epigastrium.

  • Incidence of gastric aspiration [ Time Frame: Measured between device placement/study initiation and device removal ] [ Designated as safety issue: Yes ]
    Gastric aspiration is present when gross gastric contents or bile is observed on or within the device or within the subject's oropharynx.

  • Incidence of oropharyngeal injury [ Time Frame: Measured in the post-anesthesia care unit/recovery room within 15 minutes after device removal ] [ Designated as safety issue: Yes ]
    Oropharyngeal injury is defined as a new lip, tongue, buccal, or pharyngeal abrasion or laceration or dental damage observed in the immediate recovery area after use of a study device.

  • Incidence of device repositioning and/or replacement [ Time Frame: Measured between device placement/study initiation and device removal ] [ Designated as safety issue: No ]
    Intra-operative device repositioning and/or replacement is defined as a need for intra-operative repositioning or replacement of the SGA due to excessive oropharyngeal air leak or airway obstruction, as evidenced by an obstructive pattern on the continuous end-tidal carbon dioxide monitor or audible pre-tracheal sounds, that leads to a decrease in oxygen saturation by pulse oximetry to less than 93%.

  • Hemodynamic measures at baseline [ Time Frame: Measured 1 minute prior to induction of general anesthesia ] [ Designated as safety issue: Yes ]
    Systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, heart rate, and oxygen saturation at baseline

  • Hemodynamic measures at 1 minute after device placement [ Time Frame: Measured 1 minute after device placement ] [ Designated as safety issue: Yes ]
    Systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, heart rate, and oxygen saturation 1 minute after device placement.

  • Hemodynamic measures at 2 minutes after device placement [ Time Frame: Measured 2 minutes after device placement ] [ Designated as safety issue: Yes ]
    Systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, heart rate, and oxygen saturation 2 minutes after device placement.

  • Hemodynamic measures at 3 minutes after device placement [ Time Frame: Measured 3 minutes after device placement ] [ Designated as safety issue: Yes ]
    Systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, heart rate, and oxygen saturation 3 minutes after device placement.

  • Hemodynamic measures at 4 minutes after device placement [ Time Frame: Measured 4 minutes after device placement ] [ Designated as safety issue: Yes ]
    Systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, heart rate, and oxygen saturation 4 minutes after device placement.

  • Hemodynamic measures at 5 minutes after device placement [ Time Frame: Measured 5 minutes after device placement ] [ Designated as safety issue: Yes ]
    Systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, heart rate, and oxygen saturation 5 minutes after device placement.

  • Overall clinical usefulness [ Time Frame: Reported by the device operator at the time of device removal ] [ Designated as safety issue: No ]
    Excellent, good, fair, or inadequate. Scale defined by clinical measures and observations.

  • Oropharyngolaryngeal morbidity at discharge [ Time Frame: Measured prior to discharge from phase II of the post-anesthesia care unit/recovery room ] [ Designated as safety issue: Yes ]
    Perioperative oropharyngolaryngeal morbidity is assessed by the subject's response to standardized questions regarding oropharyngeal complaints.

  • Oropharyngolaryngeal morbidity at 24 hours post-operatively [ Time Frame: Measured at 24 hours after device placement/study initiation ] [ Designated as safety issue: Yes ]
    Perioperative oropharyngolaryngeal morbidity is assessed by the subject's response to standardized questions regarding oropharyngeal complaints.


Estimated Enrollment: 225
Study Start Date: May 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: air-Q SP
air-Q Self-Pressurizing Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)
Device: air-Q SP
air-Q SP placement for airway maintenance.
Active Comparator: air-Q
air-Q Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)
Device: air-Q
air-Q placement for airway maintenance.
Active Comparator: i-gel
i-gel, sizes 3, 4, and 5 (Intersurgical Inc., Liverpool, NY, USA)
Device: i-gel
i-gel placement for airway maintenance.

Detailed Description:

Laryngeal mask airways (LMAs) are a group of airway devices, alternatively referred to as supraglottic airways (SGAs), used in anesthesia that are positioned in the back of the throat (pharynx) above (supra) the glottis (windpipe opening) and the vocal cords. This is in contradistinction to a tracheal tube, which is an airway device that is placed through the vocal cords and extends to a position below the glottis (infraglottic) and resides in the trachea (windpipe). Since their first approval for use in the United States by the US Food and Drug Administration in the early 1990s, the application of SGAs has become more widespread. Initially, they were only used in anesthetized patients who were breathing on their own (i.e., spontaneously ventilating). This was, in large part, due to a relatively low airway seal pressure, the pressure with which the device seals against the throat, thereby, keeping the air pushed in by a breathing machine (ventilator) from getting into the stomach or leaking out around the device and out through the mouth - in either case, not going into the patient's lungs. The relatively low airway seal pressure (18 - 20 cmH2O) did not allow for the use of muscle relaxant (paralyzing) drugs and positive pressure ventilation. Successive generations of SGAs by a variety of manufacturers have overcome and continue to attempt to overcome limitations of earlier devices. In addition, accumulated clinical experience has made anesthesia providers more comfortable with their use. No SGA, however, is yet ideal, and incremental changes continue to appear to improve airway management and reduce airway morbidity (e.g., sore throat, jaw pain, etc.).

The air-Q® Intubating Laryngeal Airway (aILA, Mercury Medical, Clearwater, FL) is a newer, commercially-available, SGA designed for use as a primary airway and as an intubation conduit. It is available in polyvinyl chloride (PVC)-based, single use and silicone-based, reusable models. Information on its safety and effectiveness from a randomized, controlled trial in adults, undergoing general anesthesia, compared to that of the silicone-based, reusable aILA versus the LMA-Proseal™ (pLMA, North America, San Diego, CA), the current "gold standard" for SGA airway seal pressure, is available.

The air-Q® Self-Pressurizing (SP) Intubating Laryngeal Airway (aILA-SP, Mercury Medical, Clearwater, FL) is a commercially-available, modification of the silicone-based, reusable aILA. Its overall design is identical to the aILA, but incorporates a communication orifice between the air tube and cuff, which regulates airflow into and from the cuff during periods of positive pressure and spontaneous ventilation. As such, it incorporates a self-pressurizing cuff that does not require manual inflation. Such a cuff may be advantageous insofar as it dynamically adjusts its intra-cuff pressure and fit with the patient's pharyngeal and periglottic anatomy, which may lead to a reduction in airway morbidity, while still providing the high seal pressure afforded by the aILA design.

Lastly, the i-gel (Intersurgical Inc., Liverpool, NY) is a commercially-available SGA that uses a thermoplastic elastomer to create a non-inflating, anatomically-conforming, periglottic cuff. Studies have shown it to be an easily inserted, effective airway device with a lower incidence of sore throat and neck complaints. With exception to the aILA-SP, it is the only other commercially-available SGA that does not require cuff inflation.

To date, no reports are available on the clinical performance of the aILA-SP in relation to other SGAs. Thus, the primary purpose of this study is to compare the airway seal pressure (ASP) of the aILA-SP against the aILA and i-gel in adults undergoing general anesthesia. Airway seal pressure is the most common surrogate for ventilatory capacity used in SGA studies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • < 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592760

Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Richard E Galgon, MD, MS    608-263-8100    galgon@wisc.edu   
Principal Investigator: Richard E. Galgon, MD, MS         
Sub-Investigator: Kristopher M. Schroeder, MD         
Sub-Investigator: Michael J. Hannaman, MD         
Sub-Investigator: Michael P. Ford, MD         
Sponsors and Collaborators
Richard Galgon
Investigators
Principal Investigator: Richard E Galgon, MD, MS Department of Anesthesiology, University of Wisconsin School of Medicine and Public Health
  More Information

Publications:
Responsible Party: Richard Galgon, Assistant Professor, Department of Anesthesiolgy, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01592760     History of Changes
Other Study ID Numbers: 2011-0805
Study First Received: May 2, 2012
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
air-Q SP
air-Q
i-gel
supraglottic airway device
laryngeal mask airway

ClinicalTrials.gov processed this record on August 27, 2014