IGEL Laryngeal Mask Airway Device Effectiveness in Irradiated Necks

NHS Lothian

Status: Enrolling

Conditions: Laryngeal Masks

Treatments: Device: IGEL Laryngeal mask

Study type: Interventional

Funder types: Other

Identifiers

NCT03502590

AC17094

Details and patient eligibility

About

It is known that patients with head and neck cancer who have had radiation therapy to the structures of the neck are at a greater risk of difficult mask ventilation and tracheal intubation than the majority of patients undergoing general anaesthesia.

Failure to maintain oxygenation can lead to catastrophic consequences for any patient undergoing general anaesthesia, such as severe hypoxic brain injury and death.

As such, the current guidelines from the Difficult Airway Society promote the use of a second generation laryngeal mask airway to maintain oxygenation in the event of failed mask ventilation or tracheal intubation, a rescue technique that has in most patient groups a very high chance of success. Unfortunately these guidelines are by necessity generic guidance and do not take into account the clinical performance of these devices in specific patient groups. While there is evidence of the effectiveness of the IGEL device as the primary method of airway maintenance in many studies there are none that describe its clinical performance in a group of patients in whom the rate of failed mask ventilation and tracheal intubation are significantly higher than the general population of patients. It is therefore of great interest to have an idea of the likelihood of success of rescue ventilation with this device in a group of high risk patients.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years or older
• Attending for an elective procedure requiring general anaesthesia
• Prior radiotherapy to the neck

Exclusion criteria

• General anaesthesia is not the primary airway plan
• Previously known difficult intubation
• Patient refusal

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

IGEL arm

Experimental group

Description:

Placement of a physician decided IGEl airway device in patients with prior radiotherapy to the neck to assess adequacy of ventilation

Treatment:

Device: IGEL Laryngeal mask