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
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.
NHS Lothian is the lead sponsor of 53 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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
Insertion of an IGEL device in anaesthetised patients
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
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2018 (actual). Primary completion is estimated for Sep 2027, 110 months after the start.
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