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Completed

NCT Number: NCT00983229

Comparison of CTrach, Intubating Laryngeal Mask Airway (ILMA) and I-gel for Tracheal Intubation

Various supraglottic airways may be used as a dedicated airway for insertion of intubating fibrescope and tracheal intubation in the patients with difficult to manage airways (Difficult Airway Society Guidelines).

The investigators aim to compare three different types of supraglottic device as a conduit for tracheal intubation - CTrach optical laryngeal mask, Intubating laryngeal mask airway and I-gel supraglottic airway. Null hypothesis for this study is that all three devices will perform without statistical difference in the means of success rate and time needed for their insertion and tracheal intubation.

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Key information

Conditions

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antrim Area Hospital

Antrim, BT41 2RL, United Kingdom

About this study

Supraglottic airway devices such as I-LMa, Igel and LMA Ctrach are designed to create a "dedicated" airway which safely allows both spontaneous and controlled ventilation. The use of supraglottic airways can allow planned fibreoptic intubations in expected difficult cases and can provide an emergency airway in cases of unexpected difficult airway.

The ILMA (Intavent Orthofix Ltd.,Wokingham, UK) has been designed for either blind or fibrescope-guided tracheal intubation, in patients with expected and unexpected difficult airway. Since its development in 1997, it has been used for both blind and fibrescope-guided tracheal intubations in the patients with difficult airway. The ILMA is currently a 'gold standard' in supraglottic airways used for tracheal intubation.

The I-gel (Intersurgical Ltd., Wokingham, UK) is a newer dedicated airway device, which with its wide bore allows direct passage of a tracheal tube.

The CTrach (The Laryngeal Mask Company,Singapore) is a newer device for airway management. It has special optical fibres built-in inside its bowl and a liquid crystal display which allows views of the larynx while the endotracheal tube is being placed.

With reference to these supraglottic airway devices, only a small number of case reports detail tracheal intubation through an I-gel in patients with difficult airways. There have been manikin studies comparing ILMA and CTrach, and some descriptive studies on the use of CTrach in patients with predicted difficult airways- but no studies comparing the performance of these devices in clinical practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I-III patients
  • Age 18-89 years, males and females
  • Elective surgical patients needing tracheal intubation

Exclusion criteria

  • ASA IV or V patients
  • Emergency surgical procedures
  • Patients at increased risk of aspiration

Treatment and study plan

tracheal intubation

Procedure

Insertion of a plastic tube under direct vision (built-in camera, intubating fibrescope) into trachea.

Other names: intubation, insertion of tracheal tube

Primary outcomes

  1. Success rate of tracheal intubation (%)

    Time frame: After successful insertion of tracheal tube

Secondary outcomes

  1. Time needed for successful insertion of a supraglottic device

    Time frame: After insertion

  2. Total time needed for successful tracheal intubation through a device

    Time frame: After insertion

  3. Fibreoptic view following to supraglottic device insertion

    Time frame: After insertion of SGA

  4. Complication rate - sore throat, difficulty swallowing, hoarseness, numb tongue, nausea

    Time frame: at 1 h after operation, at 24 h

Sponsors and collaborators

Lead sponsor

Northern Health and Social Care Trust

Other Gov

Registry information

Official study title

Position of Supraglottic Airway as a Conduit for Tracheal Intubation - A Comparison of CTrach, Intubating LMA and I-gel Supraglottic Airway

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 24, 2009
Registry last updated
Nov 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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