Clinical trial NCT02975466: Comparing the Efficiency of Three Third-generation Supraglottic Airways as an Intubation Route
Official title: Randomized Controlled Trial Comparing the Efficiency of Three Third Generation Supraglottic Airways as an Intubation Route
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficult Intubation
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time for intubation
timeFrame: Through study completion, an average of half an hour (no follow-up required)
Secondary outcomes:
measure: Success of intubation on first attempt
timeFrame: Through study completion, an average of half an hour (no follow-up required)
measure: Success of intubation through the SGA
timeFrame: Through study completion, an average of half an hour (no follow-up required)
measure: Number of attempts for intubation
timeFrame: Through study completion, an average of half an hour (no follow-up required)
measure: Time for whole procedure
timeFrame: Through study completion, an average of half an hour (no follow-up required)
measure: Laryngeal view grades
timeFrame: Through study completion, an average of half an hour (no follow-up required)
measure: Easiness of insertion and ventilation of the SGA
timeFrame: Through study completion, an average of half an hour (no follow-up required)
measure: Easiness of intubation
timeFrame: Through study completion, an average of half an hour (no follow-up required)
measure: Easiness of removal of the SGA after a completed endotracheal intubation
timeFrame: Through study completion, an average of half an hour (no follow-up required)
measure: Adverse events
timeFrame: Through study completion, an average of half an hour (no follow-up required)
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Centre Hospitalier Universitaire de Sherbrooke (CHUS)
name: Marie-José Colas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.