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

May 7, 2018 updated by: Marie-Josee Colas, Université de Sherbrooke

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H5N4
        • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AirQ Blocker supra-glottic airway device
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
Insertion of the SGA device and evaluation of easiness of endotracheal intubation
Experimental: AuraGain supra-glottic airway device
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
Insertion of the SGA device and evaluation of easiness of endotracheal intubation
Experimental: I-Gel supra-glottic airway device
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
Insertion of the SGA device and evaluation of easiness of endotracheal intubation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of half an hour (no follow-up required)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Success of intubation on first attempt
Time Frame: Through study completion, an average of half an hour (no follow-up required)
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?"
Through study completion, an average of half an hour (no follow-up required)
Success of intubation through the SGA
Time Frame: Through study completion, an average of half an hour (no follow-up required)
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.
Through study completion, an average of half an hour (no follow-up required)
Number of attempts for intubation
Time Frame: Through study completion, an average of half an hour (no follow-up required)
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.
Through study completion, an average of half an hour (no follow-up required)
Time for whole procedure
Time Frame: Through study completion, an average of half an hour (no follow-up required)
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.
Through study completion, an average of half an hour (no follow-up required)
Laryngeal view grades
Time Frame: Through study completion, an average of half an hour (no follow-up required)

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
Through study completion, an average of half an hour (no follow-up required)
Easiness of insertion and ventilation of the SGA
Time Frame: Through study completion, an average of half an hour (no follow-up required)

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

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.
Through study completion, an average of half an hour (no follow-up required)
Easiness of removal of the SGA after a completed endotracheal intubation
Time Frame: Through study completion, an average of half an hour (no follow-up required)

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université de Sherbrooke

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marie-José Colas, MD, Centre hospitalier universitaire de Sherbrooke (CHUS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-1484

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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