IGEL Laryngeal Mask Airway Device Effectiveness in Irradiated Necks

NCT ID: NCT03502590

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2026-09-01

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.

Conditions

Laryngeal Masks

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

IGEL arm

Placement of a physician decided IGEl airway device in patients with prior radiotherapy to the neck to assess adequacy of ventilation

Group Type: EXPERIMENTAL

IGEL Laryngeal mask

Intervention Type: DEVICE

Insertion of an IGEL device in anaesthetised patients

Interventions

IGEL Laryngeal mask

Insertion of an IGEL device in anaesthetised patients

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NHS Lothian

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St Johns Hospital

Livingston, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Grant C Price, MBChB

Role: CONTACT

grant.price@nhslothian.scot.nhs.uk

01506 523000

Claire Gillan, MBChB

Role: CONTACT

claire.gillan@nhslothian.scot.nhs.uk

01506 523000

Facility Contacts

Grant C Price, MBChB

Role: primary

grant.price@nhs.net

01506 523000

Claire Gillan, MBChB

Role: backup

claire.gillan@nhslothian.scot.nhs.uk

01506 523000

Other Identifiers

AC17094

Identifier Type: -

Identifier Source: org_study_id