Endotracheal IntubationI-gelNCT00706823
Comparison of I-gel to the Laryngeal Mask Airway
A study testing i-gel airway (Intersurgical Ltd., Wokingham, England) and Laryngeal Mask Airway-Unique in people with Endotracheal Intubation and Supraglottic Airway, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate a new disposable supra-glottic airway device, the i-gel airway (Intersurgical Ltd., Wokingham, England). We propose to test its ease of insertion, position within the airway, drain tube patency and anatomic sealing properties during mechanical ventilation in non-obese… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Endotracheal Intubation, Supraglottic Airway
- What is being tested?
- i-gel airway (Intersurgical Ltd., Wokingham, England) and Laryngeal Mask Airway-Unique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Aug 2008
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subjects will be adult surgical candidates aged 18-80, ASA I-II, Mallampati I or II, presenting for elective surgery who require general anesthesia in whom tracheal intubation is not necessary.
- Both male and female patients will be included.
Who cannot join
- Patients will be excluded from the study if they present as Mallampati III or IV, ASA III-V or emergency status. Additionally, they will be excluded if they meet one of the contraindication criteria of the LMA including:
- obesity, (BMI > 35 kg/m2)
- pregnancy
- history of gastric regurgitation, heart burn, ileus or "full stomach"
- history of low pulmonary compliance or high pulmonary resistance
- known history of difficult endotracheal intubation or signs suggesting the possibility of difficult intubation
- pharyngeal pathology
- upper airway obstruction due to laryngeal pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Comparison of the Intersurgical I-gel and the Laryngeal Mask Airway Unique in Non-Obese Adult Patients During General Surgery
The purpose of this study is to evaluate a new disposable supra-glottic airway device, the i-gel airway (Intersurgical Ltd., Wokingham, England). We propose to test its ease of insertion, position within the airway, drain tube patency and anatomic sealing properties during mechanical ventilation in non-obese anesthetized patients undergoing elective general surgery. The study device will be compared to the current standard in the industry, the LMA Unique.
Read the detailed description
During the past decade, several pharyngeal airways have been introduced for airway management, such as the Laryngeal Mask Airway (LMA), the Cobra perilaryngeal airway, the Esophageal Tracheal Combitube (ETC), the EasyTube, the Laryngeal Tube6, and the Streamlined Liner of the Pharyngeal Airway (SLIPA). These airway devices have become very popular because of their ability to maintain an airway without perturbing the trachea and can be used in patients without muscle relaxation who are only lightly anesthetized.
The LMA Classic (cLMA) generally provides an adequate airway, but certain problems remain:
- In 8-33% of LMA placements, more than one attempt is required.
- It is sometimes difficult to advance the LMA without extending the neck (which is contraindicated in some patients).
- The device does not protect the airway from aspiration of gastric contents.
- It does not provide an airtight seal around the larynx (the usual pressures causing leakage of gas being 15-20 cm H20). Consequently, the device may function poorly during positive-pressure ventilation.
- The esophagus is included within the rim of the LMA in 10-15% of patients, directly exposing the esophagus to positive airway pressures. This often results in insufflation of the stomach and postoperative discomfort.
The LMA Unique (uLMA) is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design which has been used as the "model" in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation.
The i-gel (Intersurgical Ltd., Wokingham, England) is a cuffless, single-use supraglottic airway device designed to provide a more effective seal than the uLMA, thus eliminating problems 3-5 described above with the addition of a gastric drain. Made of a gel-like thermoplastic elastomer, the i-gel has an anatomically-designed mask that allows quick, easy insertion and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff. In a preliminary study, the peak airway pressures were found to be above 30 cm H2O with a sustained leak pressure of 24 cm H2O versus an average of 18-21 cm H2O seen with the cLMA. According to the 100 patient trial, the i-gel is easier to insert, it has better sealing properties and there is no cuffed inflates.
This clinical study has been designed to compare the i-gel and the uLMA, as to ease of placement, ventilation during mechanical ventilation, proper positioning, seal pressures, the patency of the drain tube, and finally, any complications with their use. Fiberoptic observations through each device will provide information in relation to the epiglottis and the distal opening of the device.
- Conditions
- Endotracheal Intubation, Supraglottic Airway
- Being tested
- i-gel airway (Intersurgical Ltd., Wokingham, England), Laryngeal Mask Airway-Unique
- Keywords
- Endotracheal Intubation, Supraglottic Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-gel airway (Intersurgical Ltd., Wokingham, England)Device
supra-glottic airway device
Laryngeal Mask Airway-UniqueDevice
supra-glottic airway device
| Study group | Role | What they receive |
|---|---|---|
| i-gel-SGA | Experimental | Patients who received i-gel supraglottic device (i-gel airway) for intubation Receives: Device: i-gel airway (Intersurgical Ltd., Wokingham, England) |
| LMA-Unique | Active comparator | Patients who received the Laryngeal Mask Airway-Unique (uLMA) for intubation Receives: Device: Laryngeal Mask Airway-Unique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Required for Intubation
The total time to intubation was measured from the beginning of supraglottic airway device (SGA) insertion to successful endotracheal tube intubation, verified by detection of CO2 on the capnogram (anesthesia machine).
Measured: duration of intubation
Leak Pressure
After successful placement, airway leak pressure was assessed by closing the circuit to atmosphere and allowing fresh gas flow to build airway pressure. The pressure at which an audible leak was heard was recorded; airway pressure was not permitted to exceed 40 cm H2O.
Measured: duration of intubation
Secondary outcomes (4)
Level of Difficulty for Intubation
Ease of SGA insertion and intubation was subjectively assessed by the operator on a scale from 1 to 5 (1 = very easy, 2 = easy, 3 = neutral, 4 = difficult, 5 = very difficult).
Measured: duration of intubation
Number of Participants With Oropharyngeal Discomfort
Oropharyngeal discomfort was assessed. including sore throat, hoarseness, and dysphagia.
Measured: post operative, immediately and 24 hrs after intubation
Number of Participants With Successful Gastric Drainage Tube Placement as Assessed by Fiberoptic Scope Visualization
When the fiberoptic scope was placed in the gastirc drain tube of the i-gel, if the esophageal mucosa was visible and the stomach was readily accessible, then placement was considered succussful.
Measured: after intubation
Number of Attempts
The number of attempts taken to place the device
Measured: Before intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2008
- Study completionAug 2008
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.
- Other trials for Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carin A. Hagberg, The University of Texas Health Science Center, Houston
- Investigators
- Carin A Hagberg, M.D., Principal investigator, The University of Texas Medical School at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706823
- Sponsor's protocol ID
- HSC-MS-08-0004
- Acronym
- I-gel
- Status last verified
- Jan 2017
- First submitted
- 24 Jun 2008
- Last updated
- 20 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Comparison of the Intersurgical I-gel and the Laryngeal Mask Airway Unique in Non-Obese Adult Patients During General Surgery
- ClinicalTrials.gov ID
- NCT00706823
- Acronym / sponsor ID
- I-gel / HSC-MS-08-0004
- Conditions
- Endotracheal Intubation, Supraglottic Airway
- Keywords
- Endotracheal Intubation, Supraglottic Airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 30 Jun 2008 (estimated)
- Results
- Posted 5 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate a new disposable supra-glottic airway device, the i-gel airway (Intersurgical Ltd., Wokingham, England). We propose to test its ease of insertion, position within the airway, drain tube patency and anatomic sealing properties during mechanical ventilation in non-obese anesthetized patients undergoing elective general surgery. The study device will be compared to the current standard in the industry, the LMA Unique.
Detailed description
During the past decade, several pharyngeal airways have been introduced for airway management, such as the Laryngeal Mask Airway (LMA), the Cobra perilaryngeal airway, the Esophageal Tracheal Combitube (ETC), the EasyTube, the Laryngeal Tube6, and the Streamlined Liner of the Pharyngeal Airway (SLIPA). These airway devices have become very popular because of their ability to maintain an airway without perturbing the trachea and can be used in patients without muscle relaxation who are only lightly anesthetized.
The LMA Classic (cLMA) generally provides an adequate airway, but certain problems remain:
- In 8-33% of LMA placements, more than one attempt is required.
- It is sometimes difficult to advance the LMA without extending the neck (which is contraindicated in some patients).
- The device does not protect the airway from aspiration of gastric contents.
- It does not provide an airtight seal around the larynx (the usual pressures causing leakage of gas being 15-20 cm H20). Consequently, the device may function poorly during positive-pressure ventilation.
- The esophagus is included within the rim of the LMA in 10-15% of patients, directly exposing the esophagus to positive airway pressures. This often results in insufflation of the stomach and postoperative discomfort.
The LMA Unique (uLMA) is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design which has been used as the "model" in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation.
The i-gel (Intersurgical Ltd., Wokingham, England) is a cuffless, single-use supraglottic airway device designed to provide a more effective seal than the uLMA, thus eliminating problems 3-5 described above with the addition of a gastric drain. Made of a gel-like thermoplastic elastomer, the i-gel has an anatomically-designed mask that allows quick, easy insertion and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff. In a preliminary study, the peak airway pressures were found to be above 30 cm H2O with a sustained leak pressure of 24 cm H2O versus an average of 18-21 cm H2O seen with the cLMA. According to the 100 patient trial, the i-gel is easier to insert, it has better sealing properties and there is no cuffed inflates.
This clinical study has been designed to compare the i-gel and the uLMA, as to ease of placement, ventilation during mechanical ventilation, proper positioning, seal pressures, the patency of the drain tube, and finally, any complications with their use. Fiberoptic observations through each device will provide information in relation to the epiglottis and the distal opening of the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| i-gel-SGA | Experimental | Device: i-gel airway (Intersurgical Ltd., Wokingham, England)Patients who received i-gel supraglottic device (i-gel airway) for intubation |
| LMA-Unique | Active comparator | Device: Laryngeal Mask Airway-UniquePatients who received the Laryngeal Mask Airway-Unique (uLMA) for intubation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The subjects will be adult surgical candidates aged 18-80, ASA I-II, Mallampati I or II, presenting for elective surgery who require general anesthesia in whom tracheal intubation is not necessary.
- Both male and female patients will be included.
Key exclusion criteria (8 listed)
- Patients will be excluded from the study if they present as Mallampati III or IV, ASA III-V or emergency status. Additionally, they will be excluded if they meet one of the contraindication criteria of the LMA including:
- obesity, (BMI > 35 kg/m2)
- pregnancy
- history of gastric regurgitation, heart burn, ileus or "full stomach"
- history of low pulmonary compliance or high pulmonary resistance
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 airway (Intersurgical Ltd., Wokingham, England)supra-glottic airway device | Device | i-gel-SGA |
| Laryngeal Mask Airway-Uniquesupra-glottic airway device | Device | LMA-Unique |
Primary outcome
Time Required for Intubation
Time frame: duration of intubation
The total time to intubation was measured from the beginning of supraglottic airway device (SGA) insertion to successful endotracheal tube intubation, verified by detection of CO2 on the capnogram (anesthesia machine).
Leak Pressure
Time frame: duration of intubation
After successful placement, airway leak pressure was assessed by closing the circuit to atmosphere and allowing fresh gas flow to build airway pressure. The pressure at which an audible leak was heard was recorded; airway pressure was not permitted to exceed 40 cm H2O.
4 secondary outcomes
Level of Difficulty for Intubation
Time frame: duration of intubation
Number of Participants With Oropharyngeal Discomfort
Time frame: post operative, immediately and 24 hrs after intubation
Number of Participants With Successful Gastric Drainage Tube Placement as Assessed by Fiberoptic Scope Visualization
Time frame: after intubation
Number of Attempts
Time frame: Before intubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Carin A Hagberg, M.D. principal investigator
The University of Texas Medical School at Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-gel airway (Intersurgical Ltd., Wokingham, England) and Laryngeal Mask Airway-Unique in people with Endotracheal Intubation and Supraglottic Airway, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 2 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 20 Feb 2017. 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 United States. 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 5 Apr 2011). 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?
Time Required for Intubation (time frame: duration of intubation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.