NCT02975466

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

March 21, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

10 months

First QC Date

November 16, 2016

Last Update Submit

May 7, 2018

Conditions

Difficult Intubation

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (9)

  • Success of intubation on first attempt

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

  • Success of intubation through the SGA

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

  • Number of attempts for intubation

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

  • Time for whole procedure

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

  • Laryngeal view grades

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

  • +4 more secondary outcomes

Study Arms (3)

AirQ Blocker supra-glottic airway device

EXPERIMENTAL

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

Device: Insertion of AirQ Blocker and intubation through the device

AuraGain supra-glottic airway device

EXPERIMENTAL

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

Device: Insertion of AuraGain and intubation through the device

I-Gel supra-glottic airway device

EXPERIMENTAL

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

Device: Insertion of I-Gel and intubation through the device

Interventions

Insertion of AirQ Blocker and intubation through the deviceDEVICE

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

AirQ Blocker supra-glottic airway device
Insertion of AuraGain and intubation through the deviceDEVICE

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

AuraGain supra-glottic airway device
Insertion of I-Gel and intubation through the deviceDEVICE

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

I-Gel supra-glottic airway device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H5N4, Canada

Location

Related Publications (3)

  • 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

    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.

    PMID: 23364566BACKGROUND

  • 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.

    PMID: 37055702DERIVED

Study Officials

  • Marie-José Colas, MD

    Centre Hospitalier Universitaire de Sherbrooke (CHUS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

November 16, 2016

First Posted

November 29, 2016

Study Start

March 21, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

May 9, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)