IGEL Laryngeal Mask Airway Device Effectiveness in Irradiated Necks

NCT03502590 | Recruiting

• 1 other identifier: AC17094
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngeal Masks

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

IGEL arm

EXPERIMENTAL

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

Interventions

IGEL Laryngeal mask DEVICE

Insertion of an IGEL device in anaesthetised patients

IGEL arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• NHS Lothian: lead

Study Sites (1)

St Johns Hospital

Livingston, EH56 6PP, United Kingdom

RECRUITING

Central Study Contacts

Grant C Price, MBChB

CONTACT

01506 523000; grant.price@nhslothian.scot.nhs.uk

Claire Gillan, MBChB

CONTACT

01506 523000; claire.gillan@nhslothian.scot.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 18, 2018
• Study Start: July 1, 2018
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)