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CompletedNCT00706823I-gelUpdated Feb 20, 2017Results posted

Comparison of I-gel to the Laryngeal Mask Airway

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

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

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:

  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.

02

Conditions studied

  • Endotracheal Intubation
  • Supraglottic Airway

Keywords

  • Endotracheal Intubation
  • Supraglottic Airway
03

In context

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    i-gel-SGA

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

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

  • Active comparator
    LMA-Unique

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

    Device: Laryngeal Mask Airway-Unique

Interventions

  • Devicei-gel airway (Intersurgical Ltd., Wokingham, England)

    supra-glottic airway device

  • DeviceLaryngeal Mask Airway-Unique

    supra-glottic airway device

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Number of Attempts

    The number of attempts taken to place the device

    Time frame: Before intubation

07

Results

Posted Apr 5, 2011

Participant flow

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.

Participant flow — Overall Study
MilestoneI-gel-SGALMA-Unique
Started2525
Completed2525
Not completed00

Outcome measures

PrimaryTime 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
Reported as:
Mean · seconds
Time Required for Intubation
secondsI-gel-SGALMA-Unique
Time Required for Intubation21.04 ± 12.630.04 ± 14.1
Statistical analysis
  • I-gel-SGA vs LMA-Unique · t-test, 2 sided · p = 0.02
SecondaryLevel 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
Reported as:
Number · participants
Level of Difficulty for Intubation
participantsI-gel-SGALMA-Unique
Very Easy118
Easy1217
Neutral00
Difficult20
Very Difficult00
Statistical analysis
  • I-gel-SGA vs LMA-Unique · Fisher Exact · p = 0.22
SecondaryNumber 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
Reported as:
Number · participants
Number of Participants With Oropharyngeal Discomfort
participantsI-gel-SGALMA-Unique
Postop symptoms present610
Postop symptoms absent1915
PrimaryLeak 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
Reported as:
Mean · cm of H2O
Leak Pressure
cm of H2OI-gel-SGALMA-Unique
Leak Pressure23.08 ± 7.320.88 ± 4.5
Statistical analysis
  • I-gel-SGA vs LMA-Unique · t-test, 2 sided · p = 0.22
SecondaryNumber 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
Reported as:
Number · participants
Number of Participants With Successful Gastric Drainage Tube Placement as Assessed by Fiberoptic Scope Visualization
participantsI-gel-SGALMA-Unique
Esophageal mucosa visible and stomach accessible22—
Upper esophageal sphincter visible2—
Glottis visible1—
SecondaryNumber of Attempts

The number of attempts taken to place the device

Time frame:
Before intubation
Reported as:
Number · participants
Number of Attempts
participantsI-gel-SGALMA-Unique
1 attempt1721
2 attempts73
3 attempts11
Statistical analysis
  • I-gel-SGA vs LMA-Unique · Regression, Logistic · p = 0.03 · Odds ratio (or): 8.11 · 95% CI 1.1 to 58.6

Adverse events

Collected over Postoperatively, within 2 hours of emergence and extubation. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
I-gel-SGA—0/25 (0%)6/25 (24%)
LMA-Unique—0/25 (0%)10/25 (40%)
Most frequent other events
Most frequent other events
EventI-gel-SGALMA-Unique
Oropharyngeal discomfortSurgical and medical procedures6/2510/25

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)I-gel-SGALMA-UniqueTotal
<=18 years011
Between 18 and 65 years252348
>=65 years011
Age, Continuous
Age, Continuous(years)I-gel-SGALMA-UniqueTotal
Mean38.2 ± 10.535.3 ± 16.637.28 ± 13.8
Gender
Gender(Participants)I-gel-SGALMA-UniqueTotal
Female9615
Male161935
Region of Enrollment
Region of Enrollment(participants)I-gel-SGALMA-UniqueTotal
United States252550
08

Study locations

1 site
  • Memorial Hermann Hospital
    Houston, Texas 77030, United States
09

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00706823
Lead sponsor
The University of Texas Health Science Center, Houston
Responsible party
Carin A. Hagberg (◦Professor and Chairman, Joseph C. Gable, MD Endowed Chair, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Jun 30, 2008
Start date
Feb 2008
Primary completion
Aug 2008
Completion
Aug 2008
Results posted
Apr 5, 2011
Last update
Feb 20, 2017

Study contacts

Carin A Hagberg, M.D.
principal investigator · The University of Texas Medical School at Houston

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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