Air-Q® SP Versus Williams Intubating Airway for Single-Operator FOI

NCT03247803 | Completed

• 1 other identifier: 2017-0542
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The air-Q and air-Q SP are commercially-available supraglottic airways (SGAs) that can be used for primary airway maintenance or as a conduit for FOI, as can be the Williams, Ovassapian, and Berman Intubating Airways. The air-Q products have the same overall geometrical design, but differ in their cuff inflating mechanisms, where the air-Q uses a traditional pilot balloon valve, while the air-Q SP utilizes a self-inflating cuff that dynamically adjusts according to the relative resistances to airflow between the patient's lungs and the device's cuff. The purpose of this study is to compare the single-operator intubation success using the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation (FBI) and to compare the single-operator intubation success using the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation. Both devices are commercially-available and being used in the study in accordance with their labeled intended use. The investigator envisage that the endpoint of the study will be single operator intubation success rate.

Conditions

Intubation; Difficult or Failed; Laryngeal Masks

Keywords

Air-Q® SP; Williams Airway Intubator (WA); Flexible Bronchoscopic intubation (FBI); Fiberoptic Intubation (FOI); Fiberoptic Intubating Airway(FIA); Laryngeal Mask Airway

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is single-operator intubation success.

  The primary purpose of this study is to compare the single-operator intubation success using the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation.

  15 minutes

Secondary Outcomes (10)

• Time required for conduit placement

  15 minutes

• Time required for each intubation attempt

  15 minutes

• Overall intubation time

  15 minutes

• Number of attempts required for conduit placement

  15 minutes

• Number of attempts for successful intubation

  15 minutes

Study Arms (2)

Air-Q SP

EXPERIMENTAL

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

Device: air-Q® SP

Williams Intubating Airway

EXPERIMENTAL

Airway Intubator, Williams, Adult Female, Single Use, Molded Surlyn Plastic, 9 cm or Airway Intubator, Williams, Adult Male, Single Use, Molded Surlyn Plastic, 10 cm

Device: Williams Airway Intubator (WA)

Interventions

air-Q® SP DEVICE

air-Q SP placement for airway maintenance,

Also known as: air-Q SP placement for airway maintenance

Air-Q SP

Williams Airway Intubator (WA) DEVICE

WA is placed in subject's oropharynx. If the vocal cords are not in view at the end of the WA, the operator may ask an assistant to perform an airway maneuver (e.g., jaw thrust, anterior jaw lift, or lingual traction) to attempt to bring the vocal cords into view

Also known as: WA is placed in subject's oropharynx.

Williams Intubating Airway

Eligibility Criteria

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

You may qualify if:

• Adult patients (≥18 years);
• The patient is scheduled for an elective surgery or procedure that will take place in the UWHC main operating room, outpatient surgical center, or ambulatory procedure center; and
• The patient's primary anesthesia care team has planned for general anesthesia with orotracheal intubation for airway maintenance.

You may not qualify if:

• The patient is \< 18 years of age;
• The patient is non-English speaking;
• The patient is known or believed to be pregnant;
• The patient is a prisoner;
• The patient has impaired decision-making capacity;
• The patient is at increased risk for aspiration, including non-fasted or emergency surgery, and cases of uncontrolled gastroesophageal reflux disease, hiatal hernia, gastroparesis, esophageal dysmotility, prior esophagectomy, and/or emesis within twenty-four hours of the surgery or procedure;
• The patient has limited mouth opening or oropharyngeal anatomy making successful placement of the study airway conduit unlikely;
• The patient has airway exam features, a medical condition, or a past airway management history, which prompts the attending anesthesiologist to plan to maintain spontaneous ventilation during tracheal intubation;
• The patient pre-operatively is requiring supplemental oxygen;
• The patient has moderate to severe cardiac disease, as evidenced by a left ventricular ejection fraction of ≤ 50% on the most recent echocardiogram, severe aortic valve stenosis, atrial fibrillation with a resting pre-operative heart rate of ≥ 90 beats per minute, and/or known, multi-vessel coronary artery, managed conservatively with medical management or by intervention with multiple coronary artery stents or coronary bypass grafting; and
• The patient has an allergy to glycopyrrolate.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hopital 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

Related Links

• Galgon RE, Schroeder KM, Han S, et al. The air-Q(®) intubating laryngeal airway vs the LMA-ProSeal(TM) : a prospective, randomised trial of airway seal pressure. Anaesthesia. 2011 Dec;66(12):1093-100.

Study Officials

• Richard E Galgon, MD, MS

  Department of Anesthesiology,University of Wisconsin, Madison, Wisconsin, United States, 53792

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Each study subject will be blinded to the study device they receive; however, the anesthesia provider will not be blinded to the study device and will have access to all monitors deemed appropriate by the primary anesthesia team caring for the subject.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adult patients presenting for a surgical or interventional procedure requiring general anesthesia and tracheal intubation, who do not meet any of the study exclusion criteria, and who give their informed consent, will be randomly allocated to receive either an air-Q SP or Williams Intubating Airway as a conduit to aid flexible bronchoscopic intubation.

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 14, 2017
• Study Start: June 11, 2018
• Primary Completion: March 8, 2019
• Study Completion: March 8, 2019
• Last Updated: March 22, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)