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

NCT ID: NCT02975466

Last Updated: 2018-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-21

Study Completion Date

2018-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Difficult Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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AirQ Blocker supra-glottic airway device

Group of patients in which the Air-Q Blocker will be used and measured as an intubation conduit.

Group Type EXPERIMENTAL

Insertion of AirQ Blocker and intubation through the device

Intervention Type DEVICE

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

AuraGain supra-glottic airway device

Group of patients in which the AuraGain will be used and measured as an intubation conduit.

Group Type EXPERIMENTAL

Insertion of AuraGain and intubation through the device

Intervention Type DEVICE

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

I-Gel supra-glottic airway device

Group of patients in which the I-Gel will be used and measured as an intubation conduit.

Group Type EXPERIMENTAL

Insertion of I-Gel and intubation through the device

Intervention Type DEVICE

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

Interventions

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Insertion of AirQ Blocker and intubation through the device

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

Intervention Type DEVICE

Insertion of AuraGain and intubation through the device

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

Intervention Type DEVICE

Insertion of I-Gel and intubation through the device

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Marie-Josee Colas

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marie-José Colas, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Sherbrooke (CHUS)

Locations

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Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

References

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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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 23364566 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37055702 (View on PubMed)

Other Identifiers

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2017-1484

Identifier Type: -

Identifier Source: org_study_id

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