Not yet recruitingNAINTERVENTIONAL

I-scoop vs. C-Mac D-Blade Videolaryngoscope for Airway Management Under Spontaneous Breathing and Analgosedation

This research is looking into two different tools, called videolaryngoscopes (i-scoop and C-Mac D-Blade), used to help doctors gently place a breathing tube when a patient is having an operation. The main goal is to find out if the i-scoop device makes this procedure smoother and more comfortable for patients who are lightly sedated and still breathing on their own. Currently, only a small number of patients have their breathing tubes placed this way. This is because the existing methods can be tricky for doctors and sometimes uncomfortable for patients. This study hopes to improve how this important procedure is done, making it safer and more practical for more people. Patients will be randomly assigned to one of the devices and asked about their comfort afterwards.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Hannover Medical School

Enrolment target

200

Start

18 Jun 2026

Estimated completion

30 Apr 2028

Airway Management

What is this study about?

When you have an operation under general anaesthetic, a doctor often needs to help you breathe by placing a tube into your windpipe. This is called 'airway management'. Sometimes, especially if a patient's airway is expected to be a little tricky, it's safer and gentler for them to stay lightly sedated and continue breathing on their own while this tube is being put in. This method is called 'spontaneous breathing and analgosedation'. It means you're comfortable and your body's natural breathing reflexes are still working.

However, this special way of placing a breathing tube isn't used as often as it could be, even though it's recommended for certain situations. This is because the techniques currently available can be quite challenging for doctors to perform, take more time, and can sometimes be a bit uncomfortable for the patient. Researchers believe this 'gap' in practice isn't due to doctors not knowing about it, but because the current tools and methods aren't always easy or practical enough to use.

This study aims to address this problem by comparing two different types of 'videolaryngoscopes' – these are tools with a small camera that help doctors see inside the throat to place the breathing tube. One is the familiar C-Mac D-Blade, and the other is a newer device called i-scoop. The researchers want to see if using the i-scoop can make the process of placing a breathing tube under spontaneous breathing much easier and more 'practicable' for doctors, while also being more comfortable for patients. If successful, this could mean better, safer airway management for more people needing surgery in the future.

Key takeaways

Compares two devices (i-scoop vs. C-Mac D-Blade) for placing breathing tubes during surgery.
Aims to make this procedure easier and more comfortable when patients are lightly sedated and breathing on their own.
Participants will be randomly assigned to use one of the two devices.
Experiences of discomfort and recall will be checked after surgery, over one week.
Could improve safety and comfort for patients needing airway management in the future.
Participation is voluntary and you can withdraw at any time.

Who may be eligible?

To join this study, you must be 18 years old or older and be scheduled for surgery where you'll need a general anaesthetic. It's really important that you fully understand what the study involves and are happy to give your permission in writing to take part. You also need to be able to make your own decisions about your health and agree to the study procedures.

There are certain reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if you've recently taken certain pain medications (opioids) or have a history of drug or alcohol dependence. You also can't participate if you have a known allergy to lidocaine (a common local anaesthetic), or if you have certain severe health problems like unstable heart or lung conditions, or uncontrolled epilepsy that might make the study risky for you. If you've been part of another medical study within the last month, you won't be able to join this one either.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you scheduled for surgery under general anaesthetic?
Are you able to understand the study and give your consent?
Are you comfortable with receiving light sedation and local anaesthetic?
Are you currently not pregnant or breastfeeding?
Do you not have severe, unstable heart or lung problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll continue to breathe on your own while a doctor carefully manages your airway. You'll be given a light sedation (comfort medicines) and a local anaesthetic called lidocaine to numb the back of your throat before the breathing tube is placed. You'll be randomly assigned, like flipping a coin, to have your airway managed with either the i-scoop or the C-Mac D-Blade device. After your surgery, the researchers will check in with you at three different times: once in the recovery room, again the day after your operation, and then one week later. They will ask you about any discomfort you felt and if you remember anything about the procedure. This is done by someone who doesn't know which device was used, to keep things fair. The total duration of your participation will be about one week after your surgery.

Potential risks and benefits

Like all medical procedures, there are potential benefits and risks to consider. A potential benefit of participating is contributing to research that could improve how breathing tubes are inserted, making it safer and more comfortable for future patients. While the procedures are carefully standardised, there's always a small risk of discomfort or complications associated with airway management, as with any medical procedure. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Hannover Medical School
Verified postcode
Hanover, Germany

Common questions

What is 'airway management'?

It's the medical process of helping you breathe, often by placing a tube into your windpipe, especially during surgery under general anaesthetic.

What is a 'videolaryngoscope'?

It's a medical tool with a small camera that helps doctors see clearly inside your throat to put in a breathing tube more easily.

Will I be fully awake during the procedure?

No, you will be lightly sedated and have a local anaesthetic in your throat, meaning you'll be comfortable and still breathing on your own.

Why is this study important?

It aims to make placing breathing tubes safer, easier, and more comfortable for patients requiring surgery, especially those with potentially difficult airways.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, and it will not affect your medical care.

How to find out more

Konstantinos Raymondos, Professor, MD

raymondos.konstantinos@mh-hannover.de +49 176 1 532 3317 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.