Clinical trial NCT00983229: Comparison of CTrach, Intubating Laryngeal Mask Airway (ILMA) and I-gel for Tracheal Intubation
Official title: Position of Supraglottic Airway as a Conduit for Tracheal Intubation - A Comparison of CTrach, Intubating LMA and I-gel Supraglottic Airway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Keywords: difficult airway
fibreoptic intubation
supraglottic airways
laryngeal mask airway
Lead sponsor: Northern Health and Social Care Trust
Sponsor class: OTHER_GOV
First posted: 2009-09-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Success rate of tracheal intubation (%)
timeFrame: After successful insertion of tracheal tube
Secondary outcomes:
measure: Time needed for successful insertion of a supraglottic device
timeFrame: After insertion
measure: Total time needed for successful tracheal intubation through a device
timeFrame: After insertion
measure: Fibreoptic view following to supraglottic device insertion
timeFrame: After insertion of SGA
measure: Complication rate - sore throat, difficulty swallowing, hoarseness, numb tongue, nausea
timeFrame: at 1 h after operation, at 24 h
Other outcomes:
Locations:
city: Antrim
country: United Kingdom
facility: Antrim Area Hospital
Study officials:
affiliation: Northern HSC Trust
name: Pavel Michalek, MD,PhD,DESA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Campbell J, Michalek P, Deighan M. I-gel supraglottic airway for rescue airway management and as a conduit for tracheal intubation in a patient with acute respiratory failure. Resuscitation. 2009 Aug;80(8):963. doi: 10.1016/j.resuscitation.2009.04.037. Epub 2009 Jun 10. No abstract available.
citation: Michalek P, Hodgkinson P, Donaldson W. Fiberoptic intubation through an I-gel supraglottic airway in two patients with predicted difficult airway and intellectual disability. Anesth Analg. 2008 May;106(5):1501-4, table of contents. doi: 10.1213/ane.0b013e31816f22f6.
citation: Sreevathsa S, Nathan PL, John B, Danha RF, Mendonca C. Comparison of fibreoptic-guided intubation through ILMA versus intubation through LMA-CTrach. Anaesthesia. 2008 Jul;63(7):734-7. doi: 10.1111/j.1365-2044.2008.05481.x.
citation: Ferson DZ, Rosenblatt WH, Johansen MJ, Osborn I, Ovassapian A. Use of the intubating LMA-Fastrach in 254 patients with difficult-to-manage airways. Anesthesiology. 2001 Nov;95(5):1175-81. doi: 10.1097/00000542-200111000-00022.
citation: Charters P, O'Sullivan E. The 'dedicated airway': a review of the concept and an update of current practice. Anaesthesia. 1999 Aug;54(8):778-86. doi: 10.1046/j.1365-2044.1999.00888.x.
citation: Pandit JJ, MacLachlan K, Dravid RM, Popat MT. Comparison of times to achieve tracheal intubation with three techniques using the laryngeal or intubating laryngeal mask airway. Anaesthesia. 2002 Feb;57(2):128-32. doi: 10.1046/j.0003-2409.2001.02401.x.
citation: Joo HS, Kapoor S, Rose DK, Naik VN. The intubating laryngeal mask airway after induction of general anesthesia versus awake fiberoptic intubation in patients with difficult airways. Anesth Analg. 2001 May;92(5):1342-6. doi: 10.1097/00000539-200105000-00050.
citation: Ng BS, Goy RW, Bain JA, Chen FG, Liu EH. The impact of manual in-line stabilisation on ventilation and visualisation of the glottis with the LMA CTrach: a randomised crossover trial. Anaesthesia. 2009 Aug;64(8):894-8. doi: 10.1111/j.1365-2044.2009.05935.x.
citation: Liu EH, Goy RW, Lim Y, Chen FG. Success of tracheal intubation with intubating laryngeal mask airways: a randomized trial of the LMA Fastrach and LMA CTrach. Anesthesiology. 2008 Apr;108(4):621-6. doi: 10.1097/ALN.0b013e318167af61.
citation: Liu EH, Goy RW, Chen FG. An evaluation of poor LMA CTrach views with a fibreoptic laryngoscope and the effectiveness of corrective measures. Br J Anaesth. 2006 Dec;97(6):878-82. doi: 10.1093/bja/ael252. Epub 2006 Sep 19.