IGEL Laryngeal Mask Airway Device Effectiveness in Irradiated Necks

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNHS Lothian

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 years or older

Attending for an elective procedure requiring general anaesthesia

Prior radiotherapy to the neck

Disqualifiers

General anaesthesia is not the primary airway plan

Previously known difficult intubation

Patient refusal

Trial design

Design model

Single group

Treatments tested in this trial

  • IGEL Laryngeal mask

    Device

    Insertion of an IGEL device in anaesthetised patients

Treatment groups

62 Participants
are divided into 1 treatment group
Group A: IGEL armExperimental treatment 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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