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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03502590
Enrollment
62
Registered
2018-04-18
Start date
2018-07-01
Completion date
2027-09-01
Last updated
2026-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngeal Masks

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.

Interventions

DEVICEIGEL Laryngeal mask

Insertion of an IGEL device in anaesthetised patients

Sponsors

NHS Lothian
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Successful insertion of the device and ventilation of the patient10 minutesTime to successful ventilation as evidenced by 5 consecutive square wave end tidal carbon dioxide waveforms.

Countries

United Kingdom

Contacts

CONTACTGrant C Price, MBChB
grant.price@nhslothian.scot.nhs.uk01506 523000
CONTACTClaire Gillan, MBChB
claire.gillan@nhslothian.scot.nhs.uk01506 523000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026