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

Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00983229
• Other study ID #: 09/NIR03/44
• Status: Completed
• Phase: N/A
• First received: September 23, 2009
• Last updated: November 12, 2010
• Start date: August 2009
• Est. completion date: September 2010

Study information

• Verified date: October 2010
• Source: Northern Health and Social Care Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intubation

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Antrim Area Hospital	Antrim

Sponsors (1)

Lead Sponsor	Collaborator
Northern Health and Social Care Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (10)

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. — View 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. Review. — View 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. — View 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. — View 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. Epub 2006 Sep 19. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of tracheal intubation (%)		After successful insertion of tracheal tube	Yes
Secondary	Time needed for successful insertion of a supraglottic device		After insertion	Yes
Secondary	Total time needed for successful tracheal intubation through a device		After insertion	Yes
Secondary	Fibreoptic view following to supraglottic device insertion		After insertion of SGA	No
Secondary	Complication rate - sore throat, difficulty swallowing, hoarseness, numb tongue, nausea		at 1 h after operation, at 24 h	Yes