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Difficult IntubationNCT02975466

Comparing the Efficiency of Three Third-generation Supraglottic Airways as an Intubation Route

A study testing Insertion of AirQ Blocker and intubation through the device, Insertion of AuraGain and intubation through the device and Insertion of I-Gel and intubation through the device in people with Difficult Intubation, run by Université de Sherbrooke at 1 site in Canada.

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

A "can't intubate, can't oxygenate" situation is life-threatening and the physician must be prepared to react quickly. Similarly, a difficult intubation with adequate ventilation is associated with complications. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Difficult Intubation
What is being tested?
Insertion of AirQ Blocker and intubation through the device, Insertion of AuraGain and intubation through the device and Insertion of I-Gel and intubation through the device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteCanada
Study dates
21 Mar 2017to 1 Jan 2018
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age >18 years old
  • ASA score of 1-3
  • Elective or urgent surgery planned to last at least 30 minutes under general anesthesia with endotracheal intubation

Who cannot join

  • Any contraindication to the use of SGA devices considered by the anesthesiologist (Uncontrolled gastro-eosophageal reflux, oropharyngeal pathology or gross deformation, etc.)
  • Any contraindication to the drugs planned by the trial
  • Pregnancy
  • Severe or uncontrolled obstructive pulmonary disease
  • Significant cervical spine anomaly

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H5N4

Other trials in Canada

About this study

Official title: Randomized Controlled Trial Comparing the Efficiency of Three Third Generation Supraglottic Airways as an Intubation Route

A "can't intubate, can't oxygenate" situation is life-threatening and the physician must be prepared to react quickly. Similarly, a difficult intubation with adequate ventilation is associated with complications. In both of these situation and as recommend by different societies, a supra-glottic airway (SGA) device can be used to help ventilation, or as an intubation conduit to ease the airway access. The objective of this randomized controlled trial is to establish which SGA, between the AuraGain, AirQ Blocker and I-Gel, allows the fastest intubation time in an adult population, with the objective of minimizing complications related to these situations. The investigators will conduct a three-arm trial to compare different outcomes related to the installation of the SGA and its use as an intubation conduit. The results of this trial will inform the anesthesiologist on which device to use on to have close in case of airway emergencies.

Being tested
Insertion of AirQ Blocker and intubation through the device, Insertion of AuraGain and intubation through the device, Insertion of I-Gel and intubation through the device

What participants receive

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

  • Insertion of AirQ Blocker and intubation through the deviceDevice

    Insertion of the SGA device and evaluation of easiness of endotracheal intubation

  • Insertion of AuraGain and intubation through the deviceDevice

    Insertion of the SGA device and evaluation of easiness of endotracheal intubation

  • Insertion of I-Gel and intubation through the deviceDevice

    Insertion of the SGA device and evaluation of easiness of endotracheal intubation

Study groups in NCT02975466
Study groupRoleWhat they receive
AirQ Blocker supra-glottic airway deviceExperimentalGroup of patients in which the Air-Q Blocker will be used and measured as an intubation conduit.
Receives: Device: Insertion of AirQ Blocker and intubation through the device
AuraGain supra-glottic airway deviceExperimentalGroup of patients in which the AuraGain will be used and measured as an intubation conduit.
Receives: Device: Insertion of AuraGain and intubation through the device
I-Gel supra-glottic airway deviceExperimentalGroup of patients in which the I-Gel will be used and measured as an intubation conduit.
Receives: Device: Insertion of I-Gel and intubation through the device

What is being measured

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

  1. Time for intubation

    This outcome corresponds to the time required to intubate with endotracheal tube (ET) through the supra-glottic airway device. The timer will be started when the flexible fiberoptic intubation scope is inserted in the SGA, and will be stopped when the air cuff of the ET is inflated inside the trachea and carbon dioxide (CO2) is obtained. This outcome will be assessed by the either the performer or second person responsible for data collection.

    Measured: Through study completion, an average of half an hour (no follow-up required)

Secondary outcomes (9)

  1. Success of intubation on first attempt

    This outcome is dichotomic and represents success of intubation through the SGA on the first attempt. An attempt will be defined as any lowering of the ET towards the glottis. Thus, any raise of the ET to its original position on the fiberoptic intubation scope will be considered as a failed attempt. Similarly, any removal of the fiberoptic scope from the SGA will be considered as a failed attempt, regardless of an attempt to lower the ET. This primary outcome is dichotomous and answers to the question: "Was the first attempt successful?"

    Measured: Through study completion, an average of half an hour (no follow-up required)

  2. Success of intubation through the SGA

    Regardless of the number of attempts, this outcome will be considered positive if the ET penetrated the trachea, the air cuff was inflated and capnography is positive, sustained and with normal values. A failed intubation would be, for example, to leave the SGA in place for the whole surgery or to remove the SGA to complete the endotracheal intubation.

    Measured: Through study completion, an average of half an hour (no follow-up required)

  3. Number of attempts for intubation

    For example, the ET is lowered and does not enter the glottis, and is raised up again while the scope is removed from the SGA : "one" failed attempt will be noted. If the scope is entered in the SGA, no attempt to lower the ET and the scope is removed : "one" failed attempt will also be noted. However, if the scope is inserted in the SGA, the ET is lowered a first time and raised on the scope, and the ET is lowered a second time and raised again on the scope, "two" failed attempts will be considered.

    Measured: Through study completion, an average of half an hour (no follow-up required)

  4. Time for whole procedure

    The time for whole procedure corresponds to the sum of the time required for installation of the SGA device and the time required for intubation through the device.

    Measured: Through study completion, an average of half an hour (no follow-up required)

  5. Laryngeal view grades

    An evaluation of the laryngeal view on the first attempt of fibroscopy will be evaluated by the attending anesthesiologist with the following scale :

    • Grade 1 : whole vocal cords are seen, the epiglottis is not seen at all
    • Grade 2 : larynx plus the posterior surface of epiglottis are seen
    • Grade 3 : the anterior tip of the epiglottis is seen
    • Grade 4 : the anterior tip of the epiglottis is seen and encroaching on the view of vocal cords obstructing <50% of view
    • Grade 5 : the epiglottis is completely obstructing the SGA opening, no view is seen

    Measured: Through study completion, an average of half an hour (no follow-up required)

  6. Easiness of insertion and ventilation of the SGA

    The easiness of insertion and ventilation will be graded using the following scale, as proposed by Talaat and al. in his trial on Air-Q and Fastrach devices.

    • Easy means obtaining an effective airway, defined as normal chest movement and a square wave capnograph trace, from the first attempt
    • Moderate means obtaining an effective airway in the second or third attempt with some manipulation of the technique of insertion
    • Difficult means failure to obtain an effective airway after three attempts

    Measured: Through study completion, an average of half an hour (no follow-up required)

  7. Easiness of intubation

    The easiness of intubation will be subjectively evaluated by the attending anesthesiologist using the following scale:

    • Easy, meaning that railing the ET into the trachea was easy
    • Moderate, meaning that railing the ET needed mild corrective manoeuvers and the procedure was mildly longer than expected
    • Difficult, meaning that railing the ET was considerably longer than expected and that many corrective manœuvres were done, as removing and reinserting the fiberoptic scope.

    Measured: Through study completion, an average of half an hour (no follow-up required)

  8. Easiness of removal of the SGA after a completed endotracheal intubation

    The anesthesiologist will be asked to report a subjective evaluation of the removal of the SGA once the patient is intubated.

    • Easy removal
    • Moderate difficulty
    • Hard
    • Impossible

    Measured: Through study completion, an average of half an hour (no follow-up required)

  9. Adverse events

    The research team will report any adverse events. For example, accidental extubation during the removal of the SGA, blood on the device when removed, desaturation under 90%. As previously mentioned, if the attending anesthesiologist wants to stop the protocol for different reasons, as unsatisfactory ventilation, the standardized manipulations will be stopped and the anesthesiologist will pursue airway management according to his preferences.

    Measured: Through study completion, an average of half an hour (no follow-up required)

Timeline

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

  1. First posted29 Nov 2016 (estimated)
  2. Study start21 Mar 2017
  3. Primary completion1 Jan 2018
  4. Study completion1 Jan 2018

Resources

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
Masking
Single blind
Who is masked
Participant
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02975466
Sponsor's protocol ID
2017-1484
Status last verified
May 2018
First submitted
16 Nov 2016
Last updated
9 May 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Talaat AH, Mostafa AEE, Mohsen ME, Hesham SA. Comparative study between Air-Q and Intubating Laryngeal Mask Airway when used as conduit for fiber-optic. Egyptian Journal of Anaesthesia 30(2), 2013

  • Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.

    PubMed 23364566

  • Laferriere-Langlois P, Dion A, Guimond E, Nadeau F, Gagnon V, D'Aragon F, Sansoucy Y, Colas MJ. A randomized controlled trial comparing three supraglottic airway devices used as a conduit to facilitate tracheal intubation with flexible bronchoscopy. Can J Anaesth. 2023 May;70(5):851-860. doi: 10.1007/s12630-023-02444-z. Epub 2023 Apr 13.

    PubMed 37055702

Questions about this trial

What is this clinical trial studying?

A study testing Insertion of AirQ Blocker and intubation through the device, Insertion of AuraGain and intubation through the device and Insertion of I-Gel and intubation through the device in people with Difficult Intubation, run by Université de Sherbrooke at 1 site in Canada.

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 5 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 9 May 2018. 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 Canada. 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?

Time for intubation (time frame: Through study completion, an average of half an hour (no follow-up required)). 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 NCT02975466, which also lists 3 linked publications.

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 9 May 2018.

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