IGEL Laryngeal Mask Airway Device Effectiveness in Irradiated Necks
This study investigates the effectiveness of a specific breathing device, called an IGEL Laryngeal Mask, in patients who have previously undergone radiation treatment to their neck area. For these patients, helping them breathe safely during general anaesthesia can sometimes be more challenging than for others. If it's difficult to help a patient breathe, it's very important to have reliable rescue equipment readily available. While this type of device is often used successfully in many situations, there isn't much information about how well it works specifically for patients with irradiated necks. This research aims to understand how effective the IGEL device is in these higher-risk patients, to help ensure their safety during surgery.
At a glance
What is this study about?
When you have a general anaesthetic for an operation, anaesthetists use different methods to help you breathe. Sometimes, the usual ways of helping someone breathe, like using a mask or a tube down the windpipe, can be tricky. This can be more common in people who have had radiation treatment to their neck, for example, for certain types of cancer. If there's an unexpected difficulty, it's crucial to have a reliable 'rescue' device to ensure you can still get enough oxygen. Without oxygen, serious complications like brain injury can occur.
Medical guidelines suggest using a type of device called a 'second generation laryngeal mask airway' in these rescue situations. The IGEL Laryngeal Mask is one such device. While we know this type of mask works well for most people, we don't have much specific information about how effective the IGEL device is for patients who have had radiation to their neck. These patients are considered to have a higher risk for breathing difficulties during surgery.
This study aims to fill that knowledge gap. By observing how the IGEL device performs in patients with irradiated necks undergoing planned general anaesthesia, researchers hope to understand its likelihood of success in this specific group. This information could help anaesthetists make more informed decisions, ultimately improving safety for patients who need surgery after neck radiation.
Key takeaways
- This study evaluates a specific breathing device (IGEL Laryngeal Mask) for patients with prior neck radiation.
- Patients with previous neck radiation may have unique challenges with breathing during anaesthesia.
- The study aims to understand how effective the IGEL device is in these higher-risk patients.
- No extra procedures, tests, or visits are required for participants.
- Participation helps gather important safety information for future patients.
- You can choose not to participate or withdraw at any time.
Who may be eligible?
To be considered for this study, you must be at least 18 years old and be scheduled for a planned operation that requires a general anaesthetic. A key requirement is that you must have had previous radiation treatment to your neck.
You would not be able to participate if your main anaesthetic plan doesn't involve a general anaesthetic. Also, if doctors already know that it has been difficult to put a breathing tube in for you in the past, or if you simply don't wish to take part, then you wouldn't be eligible. The study is open to both men and women across all adult age ranges.
- Are you 18 years old or older?
- Are you having a planned operation under general anaesthetic?
- Have you previously had radiation treatment to your neck?
- Is your anaesthetic plan definitely for a general anaesthetic?
- Have you never been told you have a 'difficult airway' from a past anaesthetic?
- Are you happy to consider taking part?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
This study observes how the IGEL Laryngeal Mask device works during your routine general anaesthesia, so you won't have any extra visits to the hospital just for the study. There are no additional assessments or medications beyond what your anaesthetist would normally use for your surgery. Researchers will simply collect information about how the IGEL device performs if it's used during your anaesthetic. There is no follow-up specifically for the study after your operation, and the total duration of your participation is just the time you are undergoing your general anaesthetic.
Potential risks and benefits
Locations (1)
- St Johns HospitalLivingston, United Kingdom· Recruiting
Common questions
What is an IGEL Laryngeal Mask?
It's a soft, silicone device that anaesthetists can use during general anaesthesia to help you breathe, by creating a seal around your voice box without needing to go right into your windpipe.
Why are people who've had neck radiation different?
Radiation to the neck can sometimes cause changes to tissues that might make it a bit more challenging for anaesthetists to manage a patient's breathing than in someone who hasn't had this treatment.
Will I know if an IGEL Laryngeal Mask is used on me?
No, because you will be under general anaesthetic during the procedure. Your anaesthetist will decide what is best for your breathing during surgery.
Do I have to do anything extra if I join the study?
No, there are no extra tests, appointments, or medications. The study simply observes the use of a device that might be used during your planned surgery.
Can I change my mind about being in the study?
Yes, absolutely. You can decide not to participate or withdraw at any point without it affecting your medical care.
How to find out more
Grant C Price, MBChB
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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