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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United States1 site
  • Memorial Hermann Hospital

    Houston, Texas, 77030

Other trials in United States

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:

  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.

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 groups in NCT00706823
Study groupRoleWhat they receive
i-gel-SGAExperimentalPatients who received i-gel supraglottic device (i-gel airway) for intubation
Receives: Device: i-gel airway (Intersurgical Ltd., Wokingham, England)
LMA-UniqueActive comparatorPatients 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.

  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).

    Measured: 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.

    Measured: duration of intubation

Secondary outcomes (4)
  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).

    Measured: duration of intubation

  2. 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

  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.

    Measured: after intubation

  4. 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.

  1. First posted30 Jun 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionAug 2008
  4. Study completionAug 2008

Resources

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)
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
Data monitoring committee
No
Individual data sharing
Undecided

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.

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