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Comparison Study of Two Supraglottic Airway Devices Used for Patients Under General Anesthesia

NCT01001078 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-01-22

Study results available
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Summary

This study will compare two supraglottic airway devices currently on the market. Supraglottic airway devices are used during general anesthesia to provide a patent airway. They are inserted blindly into the mouth once the patient has lost consciousness and they cover the laryngeal inlet. The I-Gel and the Supreme laryngeal mask airway (LMA) are the two devices to be compared. The I-Gel has no inflatable cuff, which makes it different from all other supraglottic airway devices currently in use. The Supreme shares some characteristics of the other LMA devices, but it is disposable. Our main goal will be to compare the airway leak pressure and the peak airway pressure of each devices. We will also measure the time needed for insertion, number of attempts needed to secure the airway and side effects related to the airway (cough, dysphagia, trauma, hoarseness of voice, sore throat).

Conditions

  • Anesthesia Airway Management

Interventions

DEVICE

I-Gel supraglottic airway device

2 attempts to secure the airway will be tried. If they both fail, there will be a crossover with a Supreme LMA.

DEVICE

LMA Supreme supraglottic airway device

In the LMA Supreme group, the same interventions will be done as in the I-Gel group. The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Leak pressure will also be measure at 45 mL. Once the leak test is done, the cuff will be deflated to initial volume necessary to avoid audible leaks.

DEVICE

Standard endotracheal tube

In case both supraglottic airway devices fail, a standard endotracheal tube will be inserted

Sponsors & Collaborators

  • Maisonneuve-Rosemont Hospital

    lead OTHER

Principal Investigators

  • Pierre Drolet, MD, FRCPC · Hôpital Maisonneuve-Rosemont, Université de Montréal

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01001078 on ClinicalTrials.gov