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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| i-gel-SGA | Experimental | Patients who received i-gel supraglottic device (i-gel airway) for intubation |
|
| LMA-Unique | Active Comparator | Patients who received the Laryngeal Mask Airway-Unique (uLMA) for intubation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| i-gel airway (Intersurgical Ltd., Wokingham, England) | Device | supra-glottic airway device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | duration of intubation |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | duration of intubation |
| Number of Participants With Oropharyngeal Discomfort |
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Inclusion Criteria:
Exclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Carin A Hagberg, M.D. | The University of Texas Medical School at Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
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The patients for this study have been recruited from Feb 2008 through July 2008. The patients were recruited from the day surgery and holding areas.
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| ID | Title | Description |
|---|---|---|
| FG000 | I-gel-SGA | Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff. |
| FG001 | LMA-Unique | Patients who received LMA Unique (uLMA) for intubation. The 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | I-gel-SGA | Patients who received i-gel SGA for intubation |
| BG001 | LMA-Unique | Patients who received LMA-Unique for intubation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | seconds | duration of intubation |
|
Postoperatively, within 2 hours of emergence and extubation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | I-gel-SGA | Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oropharyngeal discomfort | Surgical and medical procedures | Systematic Assessment | Oropharyngeal discomfort, including sore throat, hoarseness, and dysphagia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carin A. Hagberg, MD | University of Texas Medical School at Houston | 713-500-6222 | carin.a.hagberg@uth.tmc.edu |
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| Laryngeal Mask Airway-Unique |
| Device |
supra-glottic airway device |
|
Oropharyngeal discomfort was assessed. including sore throat, hoarseness, and dysphagia. |
| 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. | after intubation |
| Number of Attempts | The number of attempts taken to place the device | Before intubation |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| LMA-Unique |
Patients who received LMA Unique (uLMA) for intubation. The 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. |
|
|
|
| Secondary | 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). | Posted | Number | participants | duration of intubation |
|
|
|
|
| Secondary | Number of Participants With Oropharyngeal Discomfort | Oropharyngeal discomfort was assessed. including sore throat, hoarseness, and dysphagia. | Posted | Number | participants | post operative, immediately and 24 hrs after intubation |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | cm of H2O | duration of intubation |
|
|
|
|
| Secondary | 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. | Only the -gel has a gastric drainage tube--the uLMA does not. Thus, only those receiving the i-gel were assessed for this measure. | Posted | Number | participants | after intubation |
|
|
|
| Secondary | Number of Attempts | The number of attempts taken to place the device | Posted | Number | participants | Before intubation |
|
|
|
|
| 0 |
| 25 |
| 6 |
| 25 |
| EG001 | LMA-Unique | Patients who received LMA Unique (uLMA) for intubation. The 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. | 0 | 25 | 10 | 25 |
|
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| Neutral |
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| Difficult |
|
| Very Difficult |
|
| Title | Measurements |
|---|---|
|
| 3 attempts |
|