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

NCT00983229 | Completed

• 1 other identifier: 09/NIR03/44
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Success rate of tracheal intubation (%)

  After successful insertion of tracheal tube

Secondary Outcomes (4)

• 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

Study Arms (3)

CTrach

ACTIVE COMPARATOR

1. Induction to GA with 1mcg/kg fentanyl, and 1-3 mg/kg of propofol to loss of verbal contact and neuromuscular relaxation with 0.5 mg/kg of atracurium. 2. Direct laryngoscopy, evaluation of laryngeal view grade according to Cormack-Lehane classification. 3. Insertion of CTrach (sizes 3,4 or 5), establishment of ventilation. 4. Direct evaluation of laryngeal view through CTrach 5. Tracheal intubation through CTrach LMA 6. Maintenance of anaesthesia with 02, air and sevoflurane 1-2 MAC and positive pressure ventilation 7. At the end of surgery patient will be awoken as normal. Any sign of trauma to the oral cavity and airways and gastric fluid in trachea will be noted.

Procedure: Tracheal intubation

Intubating Laryngeal Mask Airway (ILMA)

ACTIVE COMPARATOR

1. Induction to GA with 1mcg/kg fentanyl, and 1-3 mg/kg of propofol to loss of verbal contact and neuromuscular relaxation with 0.5 mg/kg of atracurium. 2. Direct laryngoscopy, evaluation of laryngeal view grade according to Cormack-Lehane classification. 3. Insertion of ILMA (sizes 3,4 or 5), establishment of ventilation. 4. Evaluation of laryngeal view through ILMA using fibrescope 5. Tracheal intubation through ILMA using fibrescope. 6. Maintenance of anaesthesia with 02, air and sevoflurane 1-2 MAC and positive pressure ventilation 7. At the end of surgery patient will be awoken as normal. Any sign of trauma to the oral cavity and airways and gastric fluid in trachea will be noted.

Procedure: Tracheal intubation

I-gel

ACTIVE COMPARATOR

1. Induction to GA with 1mcg/kg fentanyl, and 1-3 mg/kg of propofol to loss of verbal contact and neuromuscular relaxation with 0.5 mg/kg of atracurium. 2. Direct laryngoscopy, evaluation of laryngeal view grade according to Cormack-Lehane classification. 3. Insertion of I-gel (sizes 3,4 or 5), establishment of ventilation. 4. Evaluation of laryngeal view through I-gel using fibrescope 5. Tracheal intubation through I-gel using fibrescope 6. Maintenance of anaesthesia with 02, air and sevoflurane 1-2 MAC and positive pressure ventilation 7. At the end of surgery patient will be awoken as normal. Any sign of trauma to the oral cavity and airways and gastric fluid in trachea will be noted.

Procedure: Tracheal intubation

Interventions

Tracheal intubation PROCEDURE

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

Also known as: intubation, insertion of tracheal tube

CTrach; I-gel; Intubating Laryngeal Mask Airway (ILMA)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northern Health and Social Care Trust: lead

Study Sites (1)

Antrim Area Hospital

Antrim, Antrim, BT41 2RL, United Kingdom

Location

Related 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. No abstract available.

  PMID: 19520483 BACKGROUND

• 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.

  PMID: 18420867 BACKGROUND

• 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.

  PMID: 18582259 BACKGROUND

• 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.

  PMID: 11684987 BACKGROUND

• 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.

  PMID: 10460531 BACKGROUND

• 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.

  PMID: 11871949 BACKGROUND

• 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.

  PMID: 11323374 BACKGROUND

• 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.

  PMID: 19604194 BACKGROUND

• 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.

  PMID: 18362593 BACKGROUND

• 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.

  PMID: 16984953 BACKGROUND

MeSH Terms

Interventions

Intubation, Intratracheal; Intubation

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Investigative Techniques

Study Officials

• Pavel Michalek, MD,PhD,DESA

  Northern HSC Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 23, 2009
• First Posted: September 24, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: November 15, 2010

Record last verified: 2010-10

Locations

GB (1)