Endotracheal IntubationI-GelNCT00624403
Comparison of Two Type of Laryngeal Mask : I-Gel & LMA ProSeal
A study testing Laryngeal mask insertion (LMA ProSeal) and Laryngeal mask insertion (I-Gel) in people with Endotracheal Intubation, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The i-gel is a new supra glottic airway device with a non inflatable cuff and an oesophageal vent. The aim of this study is to compare this device to the LMA ProSeal. The study is approved by the institutional ethic committee. 222 patients will be enrolled in each group. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- Laryngeal mask insertion (LMA ProSeal) and Laryngeal mask insertion (I-Gel)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2008to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Weight > 30 kg
- Surgery allowing the use of laryngeal mask as airway management
- Written informed consent
Who cannot join
- Difficult intubation criteria (defined by French Anesthesia-Reanimation Society)
- Pulmonary disease
- Gastroesophageal reflux antecedent
- Coeliosurgery
- Inhalation risk
- Hiatus hernia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LMA ProSeal & I-Gel : a Prospective Controlled Trial
The i-gel is a new supra glottic airway device with a non inflatable cuff and an oesophageal vent. The aim of this study is to compare this device to the LMA ProSeal. The study is approved by the institutional ethic committee. 222 patients will be enrolled in each group. The objectives of the study will be to compare insertion success rate, leak pressure, ventilatory parameters and adverse event rate.
Read the detailed description
Supraglottic airway devices are now widely used for surgery requiring general anesthesia. Airway devices are safe and their morbidity rate is very low. The i-gel (Intersurgical Ltd, Wokingham, Berkshire, UK) is a new single-use non-inflatable supraglottic airway device that has not been evaluated in a comparative study.
The aim of this study is to compare i-gel with the LMA ProSeal in a randomized study. Anesthesia protocol is standardized. The supraglottic devices are compared in term of insertion success rate, leak pressure, ventilatory parameters and adverse events. The aim is to demonstrate an enhancement in term of insertion success rate and a diminution of the adverse events. Statistical analysis will used percentage, confidence interval and chi 2 or Fischer's exact test for qualitative data. Quantitative data will be analyzed in mean, standard deviation. Comparison will be made with a student t test or a wilcoxon test. P < 0,05 is statistically significant.
- Conditions
- Endotracheal Intubation
- Being tested
- Laryngeal mask insertion (LMA ProSeal), Laryngeal mask insertion (I-Gel)
- Keywords
- Anesthesia, Laryngeal mask airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal mask insertion (LMA ProSeal)Device
Also called LMA ProSeal
Laryngeal mask insertion
Laryngeal mask insertion (I-Gel)Device
Also called I-Gel
Laryngeal mask insertion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | LMA ProSeal Receives: Device: Laryngeal mask insertion (LMA ProSeal) |
| 2 | Experimental | I-Gel Receives: Device: Laryngeal mask insertion (I-Gel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insertion success rate
Measured: At firste attempt of insertion
Secondary outcomes (4)
Perioperative morbidity
Measured: Perioperative period
Airway sealing pressure
Measured: Once, when efficient ventilation is reached
Accessibility for stomach tube insertion
Measured: Juste after laryngeal mask insertion
Fibre-optic grade
Measured: After insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Marie CROS, Dr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624403
- Sponsor's protocol ID
- CHUBX 2007/22
- Other IDs
- 2007-A01095-48
- Acronym
- I-Gel
- Status last verified
- Jan 2014
- First submitted
- 15 Feb 2008
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Cros AM. [New laryngeal mask airway: easy and evolution to an better safety]. Ann Fr Anesth Reanim. 2006 Aug;25(8):804-5. doi: 10.1016/j.annfar.2006.06.009. Epub 2006 Jul 20. No abstract available. French.
PubMed 16859880Asai T. Editorial II: Who is at increased risk of pulmonary aspiration? Br J Anaesth. 2004 Oct;93(4):497-500. doi: 10.1093/bja/aeh234. No abstract available.
PubMed 15361474Cook TM, Lee G, Nolan JP. The ProSeal laryngeal mask airway: a review of the literature. Can J Anaesth. 2005 Aug-Sep;52(7):739-60. doi: 10.1007/BF03016565.
PubMed 16103390Keller C, Brimacombe J, Kleinsasser A, Loeckinger A. Does the ProSeal laryngeal mask airway prevent aspiration of regurgitated fluid? Anesth Analg. 2000 Oct;91(4):1017-20. doi: 10.1097/00000539-200010000-00046.
PubMed 11004067Brimacombe J, Richardson C, Keller C, Donald S. Mechanical closure of the vocal cords with the laryngeal mask airway ProSeal. Br J Anaesth. 2002 Feb;88(2):296-7. doi: 10.1093/bja/88.2.296.
PubMed 11878665Levitan RM, Kinkle WC. Initial anatomic investigations of the I-gel airway: a novel supraglottic airway without inflatable cuff. Anaesthesia. 2005 Oct;60(10):1022-6. doi: 10.1111/j.1365-2044.2005.04258.x.
PubMed 16179048Cook TM, McKinstry C, Hardy R, Twigg S. Randomized crossover comparison of the ProSeal laryngeal mask airway with the Laryngeal Tube during anaesthesia with controlled ventilation. Br J Anaesth. 2003 Nov;91(5):678-83. doi: 10.1093/bja/aeg239.
PubMed 14570790Cook TM, Nolan JP, Verghese C, Strube PJ, Lees M, Millar JM, Baskett PJ. Randomized crossover comparison of the proseal with the classic laryngeal mask airway in unparalysed anaesthetized patients. Br J Anaesth. 2002 Apr;88(4):527-33. doi: 10.1093/bja/88.4.527.
PubMed 12066729
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LMA ProSeal & I-Gel : a Prospective Controlled Trial
- ClinicalTrials.gov ID
- NCT00624403
- Acronym / sponsor ID
- I-Gel / CHUBX 2007/22
- Conditions
- Endotracheal Intubation
- Keywords
- Anesthesia, Laryngeal mask airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The i-gel is a new supra glottic airway device with a non inflatable cuff and an oesophageal vent. The aim of this study is to compare this device to the LMA ProSeal. The study is approved by the institutional ethic committee. 222 patients will be enrolled in each group. The objectives of the study will be to compare insertion success rate, leak pressure, ventilatory parameters and adverse event rate.
Detailed description
Supraglottic airway devices are now widely used for surgery requiring general anesthesia. Airway devices are safe and their morbidity rate is very low. The i-gel (Intersurgical Ltd, Wokingham, Berkshire, UK) is a new single-use non-inflatable supraglottic airway device that has not been evaluated in a comparative study.
The aim of this study is to compare i-gel with the LMA ProSeal in a randomized study. Anesthesia protocol is standardized. The supraglottic devices are compared in term of insertion success rate, leak pressure, ventilatory parameters and adverse events. The aim is to demonstrate an enhancement in term of insertion success rate and a diminution of the adverse events. Statistical analysis will used percentage, confidence interval and chi 2 or Fischer's exact test for qualitative data. Quantitative data will be analyzed in mean, standard deviation. Comparison will be made with a student t test or a wilcoxon test. P < 0,05 is statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Laryngeal mask insertion (LMA ProSeal)LMA ProSeal |
| 2 | Experimental | Device: Laryngeal mask insertion (I-Gel)I-Gel |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Weight > 30 kg
- Surgery allowing the use of laryngeal mask as airway management
- Written informed consent
Key exclusion criteria (6 listed)
- Difficult intubation criteria (defined by French Anesthesia-Reanimation Society)
- Pulmonary disease
- Gastroesophageal reflux antecedent
- Coeliosurgery
- Inhalation risk
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 |
|---|---|---|
| Laryngeal mask insertion (LMA ProSeal)Also: LMA ProSealLaryngeal mask insertion | Device | 1 |
| Laryngeal mask insertion (I-Gel)Also: I-GelLaryngeal mask insertion | Device | 2 |
Primary outcome
Insertion success rate
Time frame: At firste attempt of insertion
4 secondary outcomes
Perioperative morbidity
Time frame: Perioperative period
Airway sealing pressure
Time frame: Once, when efficient ventilation is reached
Accessibility for stomach tube insertion
Time frame: Juste after laryngeal mask insertion
Fibre-optic grade
Time frame: After insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 16859880Cros AM. [New laryngeal mask airway: easy and evolution to an better safety]. Ann Fr Anesth Reanim. 2006 Aug;25(8):804-5. doi: 10.1016/j.annfar.2006.06.009. Epub 2006 Jul 20. No abstract available. French.
- Background: PubMed 15361474Asai T. Editorial II: Who is at increased risk of pulmonary aspiration? Br J Anaesth. 2004 Oct;93(4):497-500. doi: 10.1093/bja/aeh234. No abstract available.
- Background: PubMed 16103390Cook TM, Lee G, Nolan JP. The ProSeal laryngeal mask airway: a review of the literature. Can J Anaesth. 2005 Aug-Sep;52(7):739-60. doi: 10.1007/BF03016565.
- Background: PubMed 11004067Keller C, Brimacombe J, Kleinsasser A, Loeckinger A. Does the ProSeal laryngeal mask airway prevent aspiration of regurgitated fluid? Anesth Analg. 2000 Oct;91(4):1017-20. doi: 10.1097/00000539-200010000-00046.
- Background: PubMed 11878665Brimacombe J, Richardson C, Keller C, Donald S. Mechanical closure of the vocal cords with the laryngeal mask airway ProSeal. Br J Anaesth. 2002 Feb;88(2):296-7. doi: 10.1093/bja/88.2.296.
- Background: PubMed 16179048Levitan RM, Kinkle WC. Initial anatomic investigations of the I-gel airway: a novel supraglottic airway without inflatable cuff. Anaesthesia. 2005 Oct;60(10):1022-6. doi: 10.1111/j.1365-2044.2005.04258.x.
- Background: PubMed 14570790Cook TM, McKinstry C, Hardy R, Twigg S. Randomized crossover comparison of the ProSeal laryngeal mask airway with the Laryngeal Tube during anaesthesia with controlled ventilation. Br J Anaesth. 2003 Nov;91(5):678-83. doi: 10.1093/bja/aeg239.
- Background: PubMed 12066729Cook TM, Nolan JP, Verghese C, Strube PJ, Lees M, Millar JM, Baskett PJ. Randomized crossover comparison of the proseal with the classic laryngeal mask airway in unparalysed anaesthetized patients. Br J Anaesth. 2002 Apr;88(4):527-33. doi: 10.1093/bja/88.4.527.
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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.
Anne-Marie CROS, Dr principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal mask insertion (LMA ProSeal) and Laryngeal mask insertion (I-Gel) in people with Endotracheal Intubation, run by University Hospital, Bordeaux at 1 site in France.
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 6 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 1 Jun 2026. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Insertion success rate (time frame: At firste attempt of insertion). 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 NCT00624403, which also lists 8 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 1 Jun 2026.