Intubation; Difficult or FailedNCT03247803

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

A study testing air-Q® SP and Williams Airway Intubator (WA) in people with Intubation; Difficult or Failed and Laryngeal Masks, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Intubation; Difficult or Failed, Laryngeal Masks
What is being tested?: air-Q® SP and Williams Airway Intubator (WA)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 11 Jun 2018to 8 Mar 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin Hopital and Clinics
Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: Comparison of Use of a Shortened Air-Q® Self-Pressurizing Intubating Laryngeal Airway Versus the Williams Intubating Airway for Single-Operator Flexible Bronchoscopic Intubation.

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.

Read the detailed description

Despite the introduction of videolaryngoscopes, flexible bronchoscopic intubation (FBI), also known as fiberoptic intubation (FOI), remains a critical method for achieving tracheal intubation in patients with difficult airways. Unfortunately, however, FOI often requires two-operators for success. One operator is required to manipulate the flexible bronchoscope through the patient's upper airway and into their trachea, while the second operator applies one or more maneuvers (e.g., jaw thrust, anterior jaw lift, or lingual retraction) with or without the use of a commercially-available fiberoptic intubating airway.

Previous studies have demonstrated the effectiveness of the currently available FIAs, but also illustrate the frequent need for an assistant for successful FOI. In this study, an assistant performed a jaw lift and a chin lift in all subjects as well.

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. In prior trials comparing the air-Q and air-Q SP with the two other commercially-available SGAs, the air-Q and air-Q SP bowl design provided a partial or full view of the vocal cords in 80-92% of subjects without requiring any additional airway maneuvers applied by an assistant (e.g., jaw thrust, anterior jaw lift, or lingual retraction) (Galgon, 2011; Galgon, 2015). Presumably, in these situations, successful tracheal intubation using the air-Q or air-Q SP could have been achieved by a single operator versus requiring one or more assistants. However, this potential performance advantage has not yet been tested. Therefore, the purpose of this study is to compare use of the air-Q SP against the WA for FBI performed by a single operator.

The air-Q SP, rather than the air-Q, is chosen for this study because its lack of a pilot balloon valve allows its stem to be easily shortened to ease device removal over the coaxially placed tracheal tube. The WA is chosen for this study because it has performed best in past trials and is the airway routinely used by the study principal investigator (PI) for FBI. Both devices are commercially-available and being used in the study in accordance with their labeled intended use.

Conditions: Intubation; Difficult or Failed, Laryngeal Masks
Being tested: air-Q® SP, Williams Airway Intubator (WA)
Keywords: Air-Q® SP, Williams Airway Intubator (WA), Flexible Bronchoscopic intubation (FBI), Fiberoptic Intubation (FOI), Fiberoptic Intubating Airway(FIA), Laryngeal Mask Airway

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

air-Q® SPDevice
Also called air-Q SP placement for airway maintenance
air-Q SP placement for airway maintenance,
Williams Airway Intubator (WA)Device
Also called WA is placed in subject's oropharynx.
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

Study groups in NCT03247803
Study group	Role	What they receive
Air-Q SP	Experimental	air-Q Self-Pressurizing intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mecury Medical, Clearwater, FL, USA) Receives: 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 Receives: Device: Williams Airway Intubator (WA)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 15 minutes

Secondary outcomes (10)

Time required for conduit placement
The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
Measured: 15 minutes
Time required for each intubation attempt
The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
Measured: 15 minutes
Overall intubation time
The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
Measured: 15 minutes
Number of attempts required for conduit placement
The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
Measured: 15 minutes
Number of attempts for successful intubation
The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
Measured: 15 minutes
Number and types of assistive airway maneuvers (e.g., jaw thrust, lingual retraction, etc.) for successful intubation
The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
Measured: 15 minutes
Successful intubation method
The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
Measured: 15 minutes
Tracheal tube dislodgment rate during conduit removal
The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
Measured: 15 minutes
Oxygen desaturation rate
The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
Measured: 15 minutes
Post operative sore throat rate.
The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
Measured: 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jun 20188 Mar 2019

First posted14 Aug 2017
Study start11 Jun 2018
Primary completion8 Mar 2019
Study completion8 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03247803
Sponsor's protocol ID: 2017-0542
Status last verified: Mar 2019
First submitted: 28 Jul 2017
Last updated: 22 Mar 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: There is no plan to make individual participant data available to other researchers.

Publications

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.
PubMed 21880031

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Can the "Face Index"; an Anthropometric Measurement, Predict Difficult Laryngoscopy and Intubation?
Anesthesia Intubation Complication, Laryngoscopy
RecruitingObservational study
PrediSuisse: Automatized Assessment of Difficult Airway
Anesthesia, Intubation; Difficult or Failed
RecruitingObservational study
Difficult Airway Prediction by Integrating STOP-BANG Criteria
Ventilatory Defect, Intubation; Difficult or Failed
RecruitingObservational study
Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
Failed or Difficult Intubation, Sequela, Intubation; Difficult
Active, not recruitingObservational study
Data-driven Development of a Core Dataset for Difficult Airway Alerts
Airway Management, Intubation; Difficult or Failed

All Intubation; Difficult or Failed trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Use of a Shortened Air-Q® Self-Pressurizing Intubating Laryngeal Airway Versus the Williams Intubating Airway for Single-Operator Flexible Bronchoscopic Intubation.
ClinicalTrials.gov ID: NCT03247803
Acronym / sponsor ID: 2017-0542
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Study start: 11 Jun 2018 (actual)
Primary completion: 8 Mar 2019 (actual)
Study completion: 8 Mar 2019 (actual)
First posted: 14 Aug 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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. In prior trials comparing the air-Q and air-Q SP with the two other commercially-available SGAs, the air-Q and air-Q SP bowl design provided a partial or full view of the vocal cords in 80-92% of subjects without requiring any additional airway maneuvers applied by an assistant (e.g., jaw thrust, anterior jaw lift, or lingual retraction) (Galgon, 2011; Galgon, 2015). Presumably, in these situations, successful tracheal intubation using the air-Q or air-Q SP could have been achieved by a single operator versus requiring one or more assistants. However, this potential performance advantage has not yet been tested. Therefore, the purpose of this study is to compare use of the air-Q SP against the WA for FBI performed by a single operator.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Air-Q SP	Experimental	Device: air-Q® SPair-Q Self-Pressurizing intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mecury Medical, Clearwater, FL, USA)
Williams Intubating Airway	Experimental	Device: Williams Airway Intubator (WA)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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (11 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
air-Q® SPAlso: air-Q SP placement for airway maintenanceair-Q SP placement for airway maintenance,	Device	Air-Q SP
Williams Airway Intubator (WA)Also: WA is placed in subject's oropharynx.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	Device	Williams Intubating Airway

Primary outcome

The primary endpoint is single-operator intubation success.
Time frame: 15 minutes
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.

10 secondary outcomes

Time required for conduit placement
Time frame: 15 minutes
Time required for each intubation attempt
Time frame: 15 minutes
Overall intubation time
Time frame: 15 minutes
Number of attempts required for conduit placement
Time frame: 15 minutes
Number of attempts for successful intubation
Time frame: 15 minutes
Number and types of assistive airway maneuvers (e.g., jaw thrust, lingual retraction, etc.) for successful intubation
Time frame: 15 minutes
Successful intubation method
Time frame: 15 minutes
Tracheal tube dislodgment rate during conduit removal
Time frame: 15 minutes
Oxygen desaturation rate
Time frame: 15 minutes
Post operative sore throat rate.
Time frame: 4 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
Background: PubMed 21880031Galgon 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.
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.Link provided by the sponsor.
Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.

Related trials for Intubation; Difficult or Failed

Not yet recruitingObservational study
Can the "Face Index"; an Anthropometric Measurement, Predict Difficult Laryngoscopy and Intubation?
Anesthesia Intubation Complication, Laryngoscopy
RecruitingObservational study
PrediSuisse: Automatized Assessment of Difficult Airway
Anesthesia, Intubation; Difficult or Failed
RecruitingObservational study
Difficult Airway Prediction by Integrating STOP-BANG Criteria
Ventilatory Defect, Intubation; Difficult or Failed
RecruitingObservational study
Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
Failed or Difficult Intubation, Sequela, Intubation; Difficult
Active, not recruitingObservational study
Data-driven Development of a Core Dataset for Difficult Airway Alerts
Airway Management, Intubation; Difficult or Failed

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard E Galgon, MD, MS principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing air-Q® SP and Williams Airway Intubator (WA) in people with Intubation; Difficult or Failed and Laryngeal Masks, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary endpoint is single-operator intubation success. (time frame: 15 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03247803, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2019.