IGEL Laryngeal Mask Airway Device Effectiveness in Irradiated Necks

Effectiveness of Airway Control Using the IGEL Laryngeal Mask Airway Device in Patients With Previous Radiotherapy to the Neck

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.

Study Overview

• Status: Recruiting
• Conditions: Laryngeal Masks
• Intervention / Treatment: Device: IGEL Laryngeal mask

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Grant C Price, MBChB; Phone Number: 01506 523000; Email: grant.price@nhslothian.scot.nhs.uk
• Study Contact Backup: Name: Claire Gillan, MBChB; Phone Number: 01506 523000; Email: claire.gillan@nhslothian.scot.nhs.uk

Study Locations

• United Kingdom
  • Livingston, United Kingdom, EH56 6PP
    • Recruiting
    • St Johns Hospital
    • Contact: Claire Gillan, MBChB; Phone Number: 01506 523000; Email: claire.gillan@nhslothian.scot.nhs.uk
    • Contact: Grant C Price, MBChB; Phone Number: 01506 523000; Email: grant.price@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IGEL arm; Placement of a physician decided IGEl airway device in patients with prior radiotherapy to the neck to assess adequacy of ventilation	Device: IGEL Laryngeal mask; Insertion of an IGEL device in anaesthetised patients

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NHS Lothian

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: AC17094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No