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

NCT ID: NCT01001078

Last Updated: 2015-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-03-31

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).

Detailed Description

First of all, we will record the following demographic variables: age, sex, height, weight, BMI, surgery planned, American Society of Anesthesiology (ASA) status, dental state (good, bad, edentulous), tobacco use (none, ceased, active) and packs year, Mallampati score, thyromental distance and whether or not there is trauma on the tongue, teeth or lips prior to surgery.

Induction of anesthesia will be standardized with Fentanyl 1-3 mcg/kiloGram(kG) and Propofol 1-3,5 mg/kG. The use of myorelaxant will be mandatory, but either succinylcholine or rocuronium will be used as long as complete disappearance of T1 is observed before attempting supraglottic airway insertion.

Prior to insertion, ease of ventilation (yes/no) will be noted.

The two airway devices will be used according to manufacturers instructions. The sizes of the devices will be chosen according to weight:

I-Gel: 50-90 kG: #4 and 90 Kg and up: #5 LMA Supreme: 50-70 Kg: #4 and 70-100 Kg: #5.

Patients will be randomized in either I-Gel or LMA Supreme group. Two insertions with the same device will be allowed before a crossover to the other device. If the third attempt fails, a standard endotracheal tube will be put in the trachea and blood in the oral cavity will be sought. After each failed attempt (no thoracic expansion, no carbon dioxide (CO2) square wave or leak at standardized volume. Blood on the devices will also be recorded.

Since the LMA Supreme has a cuff, we will inflate it to 25 mL and then by intervals of 5 mL of air (max 45 mL) we will inflate it at a volume where no audible leak is heard at a standardized ventilation scheme of volume controlled 8 mL/kg X 10 breaths per minute.

Once fixed with tape, we will measure peak and mean airway pressure for three breaths after 30 seconds of volume controlled breathing. Then the fresh gas flow will be fixed at 3 L/min of 50-50 air-oxygen blend and the Adjustable Pressure Limiting valve will be closed. We will look either for a plateau pressure at which a leak equal to the fresh gas flow or a pressure of 40 cm of water.

We will sought adverse effect like bronchospasm, cough, regurgitation, desaturation, aspiration and deglutition movement.

Ease of insertion will be score on a scale of 1 to 4. 1 being very easy and 4 being very hard.

Endoscopic evaluation will take place afterwards. First in the ventilation tube. Scoring for laryngeal view:

1. Vocal cords all visible;

2. Partial view of the cords including arytenoids;

3. View of the epiglottis only;

4. Other (LMA or pharynx).

Downfolding of the epiglottis will be sought.

Then we will go through the oesophageal port and see if the oesophageal mucosa il visible.

During surgery, we will check if airway manipulation and/or withdrawal was necessary and why.

If traces of blood on the devices are present at the end of the intervention it will be noted.

Two interviews will take place one at the post anesthesia care unit and another the following day by phone if the patient was having ambulatory surgery. Sore throat, cough, dysphagia and dysphonia will be asked to be graded: absent, mild, moderate or severe.

Pulse and arterial pressure with the operating room's sphygmomanometer and oximeter will be written before induction, after induction before insertion and at 1 and 2 minutes post insertion.

Conditions

Anesthesia Airway Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

I-Gel supraglottic airway device

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.

Group Type: ACTIVE_COMPARATOR

I-Gel supraglottic airway device

Intervention Type: DEVICE

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

Standard endotracheal tube

Intervention Type: DEVICE

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

LMA Supreme supraglottic airway device

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.

Group Type: ACTIVE_COMPARATOR

LMA Supreme supraglottic airway device

Intervention Type: 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.

Standard endotracheal tube

Intervention Type: DEVICE

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

Standard endotracheal tube

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

Group Type: ACTIVE_COMPARATOR

Standard endotracheal tube

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Standard endotracheal tube

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nikola Joly

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pierre Drolet, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Hôpital Maisonneuve-Rosemont, Université de Montréal

Locations

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 19512881 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19453322 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21568982 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18616521 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18349185 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19151051 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22318376 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10365012 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8424538 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20958278 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23015619 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21226431 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22329593 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23951266 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22075016 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19926388 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22178627 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25141831 (View on PubMed)

Other Identifiers

HMR-Anesth-Joly

Identifier Type: -

Identifier Source: org_study_id