NCT01001078

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2009

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

Study Start

First participant enrolled

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

January 22, 2015

Completed
Last Updated

January 22, 2015

Status Verified

January 1, 2015

Enrollment Period

1.5 years

First QC Date

October 21, 2009

Results QC Date

January 26, 2014

Last Update Submit

January 13, 2015

Conditions

Anesthesia Airway Management

Keywords

supraglottic airway devicesI-GelSupreme Laryngeal mask airwayAirway leak pressurepeak airway pressure

Outcome Measures

Primary Outcomes (1)

  • Measure of the Airway Leak Pressure

    After introduction of the supraglottic device before the beginning of the surgery.

Secondary Outcomes (5)

  • Measure of the Peak Airway Pressure

    After introduction of the SAD before the beginning of the surgery.

  • Time Needed to Secure the Airway

    From opening of the mouth to thoracic expansion and presence of End Tidal CO2 up to five minutes.

  • Number of Participants With Successful Attempts to Introduce the Devices

    At the beginning of anesthesia before the beginning of the surgery.

  • Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)

    On the day following surgery

  • Airway Manipulation and Blood on Device at Removal

    During and after anesthesia when the device is removed.

Study Arms (3)

I-Gel supraglottic airway device

ACTIVE COMPARATOR

Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.

Device: I-Gel supraglottic airway deviceDevice: Standard endotracheal tube

LMA Supreme supraglottic airway device

ACTIVE COMPARATOR

Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.

Device: LMA Supreme supraglottic airway deviceDevice: Standard endotracheal tube

Standard endotracheal tube

ACTIVE COMPARATOR

A Standard endotracheal tube will be inserted in case both other airway devices (LMA Supreme and iGel) devices fail to provide adequate ventilation.

Device: Standard endotracheal tube

Interventions

I-Gel supraglottic airway deviceDEVICE

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

I-Gel supraglottic airway device
LMA Supreme supraglottic airway deviceDEVICE

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.

LMA Supreme supraglottic airway device
Standard endotracheal tubeDEVICE

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

I-Gel supraglottic airway deviceLMA Supreme supraglottic airway deviceStandard endotracheal tube

Eligibility Criteria

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

You may qualify if:

  • Weight more than 50 kg;
  • Body Mass Index less than 30;
  • ASA I to III.

You may not qualify if:

  • Symptomatic gastro oesophageal reflux disease (GERD);
  • Non fasted patients;
  • Nasogastric tube in place;
  • Intestinal obstruction;
  • Ear, nose and throat surgery in the past or deformation of the airway;
  • Known difficult airway (Cormack-Lehane grade 3-4);
  • Oral cavity opening less than 3 cm;
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Related Publications (18)

  • Theiler LG, Kleine-Brueggeney M, Kaiser D, Urwyler N, Luyet C, Vogt A, Greif R, Unibe MM. Crossover comparison of the laryngeal mask supreme and the i-gel in simulated difficult airway scenario in anesthetized patients. Anesthesiology. 2009 Jul;111(1):55-62. doi: 10.1097/ALN.0b013e3181a4c6b9.

    PMID: 19512881BACKGROUND

  • Janakiraman C, Chethan DB, Wilkes AR, Stacey MR, Goodwin N. A randomised crossover trial comparing the i-gel supraglottic airway and classic laryngeal mask airway. Anaesthesia. 2009 Jun;64(6):674-8. doi: 10.1111/j.1365-2044.2009.05898.x.

    PMID: 19453322BACKGROUND

  • Weber U, Oguz R, Potura LA, Kimberger O, Kober A, Tschernko E. Comparison of the i-gel and the LMA-Unique laryngeal mask airway in patients with mild to moderate obesity during elective short-term surgery. Anaesthesia. 2011 Jun;66(6):481-7. doi: 10.1111/j.1365-2044.2011.06682.x.

    PMID: 21568982BACKGROUND

  • Gatward JJ, Cook TM, Seller C, Handel J, Simpson T, Vanek V, Kelly F. Evaluation of the size 4 i-gel airway in one hundred non-paralysed patients. Anaesthesia. 2008 Oct;63(10):1124-30. doi: 10.1111/j.1365-2044.2008.05561.x. Epub 2008 Jul 9.

    PMID: 18616521BACKGROUND

  • Richez B, Saltel L, Banchereau F, Torrielli R, Cros AM. A new single use supraglottic airway device with a noninflatable cuff and an esophageal vent: an observational study of the i-gel. Anesth Analg. 2008 Apr;106(4):1137-9, table of contents. doi: 10.1213/ane.0b013e318164f062.

    PMID: 18349185BACKGROUND

  • Uppal V, Fletcher G, Kinsella J. Comparison of the i-gel with the cuffed tracheal tube during pressure-controlled ventilation. Br J Anaesth. 2009 Feb;102(2):264-8. doi: 10.1093/bja/aen366.

    PMID: 19151051BACKGROUND

  • Wong DT, Yang JJ, Jagannathan N. Brief review: The LMA Supreme supraglottic airway. Can J Anaesth. 2012 May;59(5):483-93. doi: 10.1007/s12630-012-9673-0. Epub 2012 Feb 9.

    PMID: 22318376BACKGROUND

  • Keller C, Brimacombe JR, Keller K, Morris R. Comparison of four methods for assessing airway sealing pressure with the laryngeal mask airway in adult patients. Br J Anaesth. 1999 Feb;82(2):286-7. doi: 10.1093/bja/82.2.286.

    PMID: 10365012BACKGROUND

  • Brimacombe J, Berry A. A proposed fiber-optic scoring system to standardize the assessment of laryngeal mask airway position. Anesth Analg. 1993 Feb;76(2):457. No abstract available.

    PMID: 8424538BACKGROUND

  • Teoh WH, Lee KM, Suhitharan T, Yahaya Z, Teo MM, Sia AT. Comparison of the LMA Supreme vs the i-gel in paralysed patients undergoing gynaecological laparoscopic surgery with controlled ventilation. Anaesthesia. 2010 Dec;65(12):1173-9. doi: 10.1111/j.1365-2044.2010.06534.x. Epub 2010 Oct 19.

    PMID: 20958278BACKGROUND

  • Russo SG, Cremer S, Eich C, Jipp M, Cohnen J, Strack M, Quintel M, Mohr A. Magnetic resonance imaging study of the in vivo position of the extraglottic airway devices i-gel and LMA-Supreme in anaesthetized human volunteers. Br J Anaesth. 2012 Dec;109(6):996-1004. doi: 10.1093/bja/aes314. Epub 2012 Sep 25.

    PMID: 23015619BACKGROUND

  • Chew EE, Hashim NH, Wang CY. Randomised comparison of the LMA Supreme with the I-Gel in spontaneously breathing anaesthetised adult patients. Anaesth Intensive Care. 2010 Nov;38(6):1018-22. doi: 10.1177/0310057X1003800609.

    PMID: 21226431BACKGROUND

  • Ragazzi R, Finessi L, Farinelli I, Alvisi R, Volta CA. LMA Supreme vs i-gel--a comparison of insertion success in novices. Anaesthesia. 2012 Apr;67(4):384-8. doi: 10.1111/j.1365-2044.2011.07002.x. Epub 2012 Feb 13.

    PMID: 22329593BACKGROUND

  • Chen X, Jiao J, Cong X, Liu L, Wu X. A comparison of the performance of the I-gel vs. the LMA-Sduring anesthesia: a meta-analysis of randomized controlled trials. PLoS One. 2013 Aug 12;8(8):e71910. doi: 10.1371/journal.pone.0071910. eCollection 2013.

    PMID: 23951266BACKGROUND

  • Halwagi AE, Massicotte N, Lallo A, Gauthier A, Boudreault D, Ruel M, Girard F. Tracheal intubation through the I-gel supraglottic airway versus the LMA Fastrach: a randomized controlled trial. Anesth Analg. 2012 Jan;114(1):152-6. doi: 10.1213/ANE.0b013e318236f438. Epub 2011 Nov 10.

    PMID: 22075016BACKGROUND

  • Michalek P, Donaldson W, Graham C, Hinds JD. A comparison of the I-gel supraglottic airway as a conduit for tracheal intubation with the intubating laryngeal mask airway: a manikin study. Resuscitation. 2010 Jan;81(1):74-7. doi: 10.1016/j.resuscitation.2009.10.009. Epub 2009 Nov 17.

    PMID: 19926388BACKGROUND

  • Hernandez MR, Klock PA Jr, Ovassapian A. Evolution of the extraglottic airway: a review of its history, applications, and practical tips for success. Anesth Analg. 2012 Feb;114(2):349-68. doi: 10.1213/ANE.0b013e31823b6748. Epub 2011 Dec 16.

    PMID: 22178627BACKGROUND

  • Joly N, Poulin LP, Tanoubi I, Drolet P, Donati F, St-Pierre P. Randomized prospective trial comparing two supraglottic airway devices: i-gel and LMA-Supreme in paralyzed patients. Can J Anaesth. 2014 Sep;61(9):794-800. doi: 10.1007/s12630-014-0198-6. Epub 2014 Aug 21.

    PMID: 25141831DERIVED

Results Point of Contact

Title
Nikola Joly, M.D.
Organization
Maisonneuve-Rosemont Hospital
nikola.joly@umontreal.ca
+1 514 252 3426

Study Officials

  • Pierre Drolet, MD, FRCPC

    Hôpital Maisonneuve-Rosemont, Université de Montréal

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 21, 2009

First Posted

October 23, 2009

Study Start

September 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

January 22, 2015

Results First Posted

January 22, 2015

Record last verified: 2015-01

Locations

CA(1)