IGEL Laryngeal Mask Airway Device Effectiveness in Irradiated Necks

Laryngeal Masks Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03502590
• Other study ID #: AC17094
• Status: Not yet recruiting
• Phase: N/A
• First received: April 11, 2018
• Last updated: April 17, 2018
• Start date: July 1, 2018
• Est. completion date: June 2021

Study information

• Verified date: February 2018
• Source: NHS Lothian
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: June 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laryngeal Masks

Intervention

Device:
• IGEL Laryngeal mask
Insertion of an IGEL device in anaesthetised patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NHS Lothian

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 minutes