ClinicalTrials.gg
RecruitingNCT03502590Updated Feb 19, 2026

IGEL Laryngeal Mask Airway Device Effectiveness in Irradiated Necks

An interventional study of IGEL Laryngeal mask in Laryngeal Masks, sponsored by NHS Lothian. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-19.

Sponsored by NHS Lothian · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Jul 2018; still recruiting 8 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Laryngeal Masks
03

In context

Lead sponsor

NHS Lothian is the lead sponsor of 53 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • General anaesthesia is not the primary airway plan
  • Previously known difficult intubation
  • Patient refusal
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
62 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceIGEL Laryngeal mask

    Insertion of an IGEL device in anaesthetised patients

06

What researchers measure

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.

    Time frame: 10 minutes

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2018 (actual). Primary completion is estimated for Sep 2027, 110 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 11, 2018
First posted
Apr 18, 2018
StartActual
Jul 1, 2018
Primary completionEst.
Sep 1, 2027
CompletionEst.
Sep 1, 2027
Last update
Feb 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03502590
Lead sponsor
NHS Lothian
Responsible party
Sponsor
First posted
Apr 18, 2018
Start date
Jul 1, 2018
Primary completion
Sep 1, 2027 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
Feb 19, 2026

Study contacts

Grant C Price, MBChB
Contact
grant.price@nhslothian.scot.nhs.uk
01506 523000
Claire Gillan, MBChB
Contact
claire.gillan@nhslothian.scot.nhs.uk
01506 523000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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