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Clinical Trials/NCT02975466
NCT02975466
Completed
Not Applicable

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

Université de Sherbrooke1 site in 1 country150 target enrollmentMarch 21, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Difficult Intubation
Sponsor
Université de Sherbrooke
Enrollment
150
Locations
1
Primary Endpoint
Time for intubation
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 21, 2017
End Date
January 1, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marie-Josee Colas

Anesthesiologist

Université de Sherbrooke

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

Outcomes

Primary Outcomes

Time for intubation

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

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.

Secondary Outcomes

  • 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))
  • Easiness of insertion and ventilation of the SGA(Through study completion, an average of half an hour (no follow-up required))
  • Easiness of intubation(Through study completion, an average of half an hour (no follow-up required))
  • Easiness of removal of the SGA after a completed endotracheal intubation(Through study completion, an average of half an hour (no follow-up required))
  • Adverse events(Through study completion, an average of half an hour (no follow-up required))

Study Sites (1)

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