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

Northern Health and Social Care Trust

Status: Completed

Conditions: Intubation

Treatments: Procedure: Tracheal intubation

Study type: Interventional

Funder types: Other

Identifiers

NCT00983229

09/NIR03/44

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

CTrach

Active Comparator group

Description:

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.

Treatment:

Procedure: Tracheal intubation

Intubating Laryngeal Mask Airway (ILMA)

Active Comparator group

Description:

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.

Treatment:

Procedure: Tracheal intubation

I-gel

Active Comparator group

Description:

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.

Treatment:

Procedure: Tracheal intubation