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NCT Number: NCT03502590

IGEL Laryngeal Mask Airway Device Effectiveness in Irradiated Necks

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IGEL Laryngeal mask

Device

Insertion of an IGEL device in anaesthetised patients

Primary outcomes

  1. Successful insertion of the device and ventilation of the patient

    Time frame: 10 minutes

    Time to successful ventilation as evidenced by 5 consecutive square wave end tidal carbon dioxide waveforms.

Study contacts

Contact information is provided by the study sponsor or research team.

Claire Gillan, MBChB

CONTACT

[email protected]

01506 523000

Grant C Price, MBChB

CONTACT

[email protected]

01506 523000

Sponsors and collaborators

Lead sponsor

NHS Lothian

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Apr 18, 2018
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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