Anesthesia Airway ManagementNCT01001078

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

A study testing I-Gel supraglottic airway device, LMA Supreme supraglottic airway device and Standard endotracheal tube in people with Anesthesia Airway Management, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Anesthesia Airway Management
What is being tested?: I-Gel supraglottic airway device, LMA Supreme supraglottic airway device and Standard endotracheal tube
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteCanada
Study dates: Sep 2009to Mar 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4

Other trials in Canada

About this study

Official title: Prospective Randomized Trial Comparing the Performance of Two Supraglottic Airway Management Devices: I-Gel and Supreme LMA

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).

Read the 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:

Vocal cords all visible;
Partial view of the cords including arytenoids;
View of the epiglottis only;
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
Being tested: I-Gel supraglottic airway device, LMA Supreme supraglottic airway device, Standard endotracheal tube
Keywords: supraglottic airway devices, I-Gel, Supreme Laryngeal mask airway, Airway leak pressure, peak airway pressure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01001078
Study group	Role	What they receive
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. Receives: Device: I-Gel supraglottic airway device; Device: 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. Receives: Device: LMA Supreme supraglottic airway device; Device: 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. Receives: Device: Standard endotracheal tube

What is being measured

The primary outcome is the main question the study is designed to answer.

Measure of the Airway Leak Pressure
Measured: After introduction of the supraglottic device before the beginning of the surgery.

Secondary outcomes (5)

Measure of the Peak Airway Pressure
Measured: After introduction of the SAD before the beginning of the surgery.
Time Needed to Secure the Airway
Measured: 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
Measured: At the beginning of anesthesia before the beginning of the surgery.
Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)
Intent to treat assessment of adverse events, per intervention, was intended. The adverse effects were assessed by phone; or in person if patient in the hospital; on the following day.
Measured: On the day following surgery
Airway Manipulation and Blood on Device at Removal
Measured: During and after anesthesia when the device is removed.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Mar 2011

First posted23 Oct 2009 (estimated)
Study startSep 2009
Primary completionMar 2011
Study completionMar 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Anesthesia Airway ManagementStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01001078
Sponsor's protocol ID: HMR-Anesth-Joly
Status last verified: Jan 2015
First submitted: 21 Oct 2009
Last updated: 22 Jan 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 19512881
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.
PubMed 19453322
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.
PubMed 21568982
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.
PubMed 18616521
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.
PubMed 18349185
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.
PubMed 19151051
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.
PubMed 22318376
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.
PubMed 10365012
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.
PubMed 8424538
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.
PubMed 20958278
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.
PubMed 23015619
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.
PubMed 21226431
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.
PubMed 22329593
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.
PubMed 23951266
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.
PubMed 22075016

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
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Airway Management, Anesthesia, General
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Title of Study: Anesthesiologists' Learning Curves for Ultrasound Assessment of Difficult Airway
Airway Ultrasound, Difficult Airway Management

All Anesthesia Airway Management trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Randomized Trial Comparing the Performance of Two Supraglottic Airway Management Devices: I-Gel and Supreme LMA
ClinicalTrials.gov ID: NCT01001078
Acronym / sponsor ID: HMR-Anesth-Joly
Conditions: Anesthesia Airway Management
Keywords: supraglottic airway devices, I-Gel, Supreme Laryngeal mask airway, Airway leak pressure, peak airway pressure
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Maisonneuve-Rosemont HospitalUniversity, hospital or other
Study start: Sep 2009
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 23 Oct 2009 (estimated)
Results: Posted 22 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

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:

Vocal cords all visible;
Partial view of the cords including arytenoids;
View of the epiglottis only;
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.

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
I-Gel supraglottic airway device	Active comparator	Device: I-Gel supraglottic airway device, Device: Standard endotracheal tubeGroup 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.
LMA Supreme supraglottic airway device	Active comparator	Device: LMA Supreme supraglottic airway device, Device: Standard endotracheal tubeGroup 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.
Standard endotracheal tube	Active comparator	Device: Standard endotracheal tubeA Standard endotracheal tube will be inserted in case both other airway devices (LMA Supreme and iGel) devices fail to provide adequate ventilation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
I-Gel supraglottic airway device2 attempts to secure the airway will be tried. If they both fail, there will be a crossover with a Supreme LMA.	Device	I-Gel supraglottic airway device
LMA Supreme supraglottic airway deviceIn 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	LMA Supreme supraglottic airway device
Standard endotracheal tubeIn case both supraglottic airway devices fail, a standard endotracheal tube will be inserted	Device	I-Gel supraglottic airway device, LMA Supreme supraglottic airway device, Standard endotracheal tube

Primary outcome

Measure of the Airway Leak Pressure
Time frame: After introduction of the supraglottic device before the beginning of the surgery.

5 secondary outcomes

Measure of the Peak Airway Pressure
Time frame: After introduction of the SAD before the beginning of the surgery.
Time Needed to Secure the Airway
Time frame: 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
Time frame: At the beginning of anesthesia before the beginning of the surgery.
Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)
Time frame: On the day following surgery
Airway Manipulation and Blood on Device at Removal
Time frame: During and after anesthesia when the device is removed.

Results and safety

Results posted to the registry on 22 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
I-Gel	50	50
LMA Supreme	50	50

Primary outcome: Measure of the Airway Leak Pressure

Time frame: After introduction of the supraglottic device before the beginning of the surgery.. Mean (Standard Deviation). Unit: cmH2O

Measure	I-Gel n = 46	LMA Supreme n = 46
Value	23 (7)	21 (8)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 hour after placement of the device. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
I-Gel	0 of 50 (0%)	23 of 50 (46%)	Not reported
LMA Supreme	0 of 50 (0%)	31 of 50 (62%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19512881Theiler 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.
Background: PubMed 19453322Janakiraman 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.
Background: PubMed 21568982Weber 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.
Background: PubMed 18616521Gatward 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.
Background: PubMed 18349185Richez 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.
Background: PubMed 19151051Uppal 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.
Background: PubMed 22318376Wong 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.
Background: PubMed 10365012Keller 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.
Background: PubMed 8424538Brimacombe 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.
Background: PubMed 20958278Teoh 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.
Background: PubMed 23015619Russo 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.
Background: PubMed 21226431Chew 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pierre Drolet, MD, FRCPC principal investigator

Hôpital Maisonneuve-Rosemont, Université de Montréal

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure of the Airway Leak Pressure (time frame: After introduction of the supraglottic device before the beginning of the surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01001078, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2015.