Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID03502590

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

Led by NHS Lothian · Updated on 2026-02-19

62

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the effectiveness of the IGEL laryngeal mask airway device in patients who have had radiation therapy to the neck. These patients face a higher risk of difficult mask ventilation and tracheal intubation during general anesthesia compared to most patients. The study aims to understand how well the IGEL device works as a rescue tool for maintaining oxygenation in this high-risk group, where failure to maintain oxygen can cause severe brain injury or death. The study involves inserting the IGEL device in anesthetized patients who have previously received radiotherapy to the neck. This device is being evaluated as a method to ensure adequate ventilation during surgery. The procedure is planned by physicians and is part of elective surgeries requiring general anesthesia. The study focuses on how successfully the device can be placed and used to ventilate the patient within a 10-minute timeframe. Participants will undergo the insertion of the IGEL device during their scheduled surgery. Researchers will assess the success of device placement and ventilation during this time. Data collected will focus on the effectiveness of airway control with this device in patients with previous neck radiation. The study does not involve blinding or comparison groups and will continue until September 2027. Participants are monitored closely to ensure safety during the procedure.

CONDITIONS

Brief Title

IGEL Laryngeal Mask Airway Device Effectiveness in Irradiated Necks

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Scheduled for an elective procedure requiring general anesthesia
  • Previous radiotherapy to the neck
Not Eligible

You will not qualify if you...

  • General anesthesia is not the primary airway plan
  • Known history of difficult intubation
  • Patient refusal

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - During the elective procedure

Participants have an IGEL laryngeal mask airway device inserted while anaesthetised to assess airway control effectiveness.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

St Johns Hospital

Livingston, United Kingdom, EH56 6PP

Actively Recruiting

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Research Team

G

Grant C Price, MBChB

C

Claire Gillan, MBChB

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

Frequently Asked Questions

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