IGEL Laryngeal Mask Airway Device Effectiveness in Irradiated Necks

Not Applicable

Recruiting

• Conditions: Laryngeal Masks
• Interventions: Device: IGEL Laryngeal mask

• Registration Number: NCT03502590
• Lead Sponsor: NHS Lothian

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-04-17
• Study First Posted: 2018-04-18
• Study Start: 2018-07-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-28
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IGEL arm	IGEL Laryngeal mask	-

Primary Outcome Measures

Name	Time	Method
Successful insertion of the device and ventilation of the patient	10 minutes	Time to successful ventilation as evidenced by 5 consecutive square wave end tidal carbon dioxide waveforms.

Trial Locations

Locations (1)

St Johns Hospital; 🇬🇧 Livingston, United Kingdom