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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00983229
Enrollment
120
Registered
2009-09-24
Start date
2009-08-31
Completion date
2010-09-30
Last updated
2010-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation

Keywords

difficult airway, fibreoptic intubation, supraglottic airways, laryngeal mask airway

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.

Interventions

PROCEDURETracheal intubation

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

Sponsors

Northern Health and Social Care Trust
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Success rate of tracheal intubation (%)After successful insertion of tracheal tube

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026