An interventional study of i-gel airway (Intersurgical Ltd., Wokingham, England) and Laryngeal Mask Airway-Unique in Endotracheal Intubation and Supraglottic Airway, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-20.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
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.
The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
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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:
Patients who received i-gel supraglottic device (i-gel airway) for intubation
Device: i-gel airway (Intersurgical Ltd., Wokingham, England)
Patients who received the Laryngeal Mask Airway-Unique (uLMA) for intubation
Device: Laryngeal Mask Airway-Unique
supra-glottic airway device
supra-glottic airway device
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).
Time frame: 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.
Time frame: duration of intubation
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).
Time frame: duration of intubation
Number of Participants With Oropharyngeal Discomfort
Oropharyngeal discomfort was assessed. including sore throat, hoarseness, and dysphagia.
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
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.
Time frame: after intubation
Number of Attempts
The number of attempts taken to place the device
Time frame: Before intubation
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.
| Milestone | I-gel-SGA | LMA-Unique |
|---|---|---|
| Started | 25 | 25 |
| Completed | 25 | 25 |
| Not completed | 0 | 0 |
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).
| seconds | I-gel-SGA | LMA-Unique |
|---|---|---|
| Time Required for Intubation | 21.04 ± 12.6 | 30.04 ± 14.1 |
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).
| participants | I-gel-SGA | LMA-Unique |
|---|---|---|
| Very Easy | 11 | 8 |
| Easy | 12 | 17 |
| Neutral | 0 | 0 |
| Difficult | 2 | 0 |
| Very Difficult | 0 | 0 |
Oropharyngeal discomfort was assessed. including sore throat, hoarseness, and dysphagia.
| participants | I-gel-SGA | LMA-Unique |
|---|---|---|
| Postop symptoms present | 6 | 10 |
| Postop symptoms absent | 19 | 15 |
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.
| cm of H2O | I-gel-SGA | LMA-Unique |
|---|---|---|
| Leak Pressure | 23.08 ± 7.3 | 20.88 ± 4.5 |
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.
| participants | I-gel-SGA | LMA-Unique |
|---|---|---|
| Esophageal mucosa visible and stomach accessible | 22 | — |
| Upper esophageal sphincter visible | 2 | — |
| Glottis visible | 1 | — |
The number of attempts taken to place the device
| participants | I-gel-SGA | LMA-Unique |
|---|---|---|
| 1 attempt | 17 | 21 |
| 2 attempts | 7 | 3 |
| 3 attempts | 1 | 1 |
Collected over Postoperatively, within 2 hours of emergence and extubation. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| I-gel-SGA | — | 0/25 (0%) | 6/25 (24%) |
| LMA-Unique | — | 0/25 (0%) | 10/25 (40%) |
| Event | I-gel-SGA | LMA-Unique |
|---|---|---|
| Oropharyngeal discomfortSurgical and medical procedures | 6/25 | 10/25 |
| Age, Categorical(Participants) | I-gel-SGA | LMA-Unique | Total |
|---|---|---|---|
| <=18 years | 0 | 1 | 1 |
| Between 18 and 65 years | 25 | 23 | 48 |
| >=65 years | 0 | 1 | 1 |
| Age, Continuous(years) | I-gel-SGA | LMA-Unique | Total |
|---|---|---|---|
| Mean | 38.2 ± 10.5 | 35.3 ± 16.6 | 37.28 ± 13.8 |
| Gender(Participants) | I-gel-SGA | LMA-Unique | Total |
|---|---|---|---|
| Female | 9 | 6 | 15 |
| Male | 16 | 19 | 35 |
| Region of Enrollment(participants) | I-gel-SGA | LMA-Unique | Total |
|---|---|---|---|
| United States | 25 | 25 | 50 |
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