Comparison of I-gel to the Laryngeal Mask Airway

NCT ID: NCT00706823

Last Updated: 2017-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2008-08-31

Brief 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 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:

1. In 8-33% of LMA placements, more than one attempt is required.

2. It is sometimes difficult to advance the LMA without extending the neck (which is contraindicated in some patients).

3. The device does not protect the airway from aspiration of gastric contents.

4. 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.

5. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

i-gel-SGA

Patients who received i-gel supraglottic device (i-gel airway) for intubation

Group Type: EXPERIMENTAL

i-gel airway (Intersurgical Ltd., Wokingham, England)

Intervention Type: DEVICE

supra-glottic airway device

LMA-Unique

Patients who received the Laryngeal Mask Airway-Unique (uLMA) for intubation

Group Type: ACTIVE_COMPARATOR

Laryngeal Mask Airway-Unique

Intervention Type: DEVICE

supra-glottic airway device

Interventions

i-gel airway (Intersurgical Ltd., Wokingham, England)

supra-glottic airway device

Intervention Type: DEVICE

Laryngeal Mask Airway-Unique

supra-glottic airway device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Both male and female patients will be included.

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:

1. obesity, (BMI > 35 kg/m2)

2. pregnancy

3. history of gastric regurgitation, heart burn, ileus or "full stomach"

4. history of low pulmonary compliance or high pulmonary resistance

5. known history of difficult endotracheal intubation or signs suggesting the possibility of difficult intubation

6. pharyngeal pathology

7. upper airway obstruction due to laryngeal pathology

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Carin A. Hagberg

◦Professor and Chairman, Joseph C. Gable, MD Endowed Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carin A Hagberg, M.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Medical School at Houston

Locations

Memorial Hermann Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-08-0004

Identifier Type: -

Identifier Source: org_study_id