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

Not Applicable

Completed

• Conditions: Intubation

• Registration Number: NCT00983229
• Lead Sponsor: Northern Health and Social Care Trust

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-23
• Study First Submitted QC: 2009-09-23
• Study First Posted: 2009-09-24
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2010-10
• Last Update Submitted: 2010-11-12
• Last Update Posted: 2010-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Success rate of tracheal intubation (%)	After successful insertion of tracheal tube

Secondary Outcome Measures

Name	Time	Method
Time needed for successful insertion of a supraglottic device	After insertion
Total time needed for successful tracheal intubation through a device	After insertion
Fibreoptic view following to supraglottic device insertion	After insertion of SGA
Complication rate - sore throat, difficulty swallowing, hoarseness, numb tongue, nausea	at 1 h after operation, at 24 h

Trial Locations

Locations (1)

Antrim Area Hospital; 🇬🇧 Antrim, United Kingdom