RecruitingOBSERVATIONAL

Classification and Prediction of Difficult Awake Tracheal Intubation With Flexible Bronchoscopes

This research is about improving how doctors manage breathing during medical procedures, especially when it's expected to be tricky. Sometimes, doctors need to place a breathing tube while a patient is awake, using a flexible scope called a bronchoscope. Currently, the tools they use to recognise and prepare for difficult situations aren't perfect for this specific method. This study aims to create new, more accurate systems to predict whether placing the tube will be difficult before it even starts, and to classify how difficult it was afterwards. The goal is to make these procedures safer and easier for patients by giving doctors better information.

At a glance

Status

Recruiting

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Enrolment target

313

Start

30 Apr 2025

Estimated completion

31 Jan 2026

Anesthesia Airway Management Intubation, Intratracheal Bronchoscopy Endoscopes

What is this study about?

When you have a medical procedure, sometimes doctors need to help you breathe by putting a tube into your windpipe. This is called intubation. If doctors think it might be difficult to do this in the usual way, they might use a special technique called "awake intubation with a flexible bronchoscope." This means they carefully place a thin, flexible tube while you are awake (though you will receive medicine to make you numb and comfortable), allowing you to continue breathing on your own. This method is used when it's safer than putting you completely to sleep first.

Currently, the tools doctors use to rate how difficult an intubation might be were mainly designed for different methods. They don't always give the best picture for awake intubations with flexible scopes. This study wants to change that. Researchers are trying to develop new and improved ways to predict if an awake intubation will be difficult *before* it happens. They also want to create a better system to classify how difficult it *was* after the procedure is finished.

The main aim is to make these procedures safer and gentler for patients. By having better prediction tools, doctors can be more prepared, choose the best approach, and reduce any potential problems. Ultimately, this research hopes to improve how we manage breathing support in hospitals, making a big difference for patients needing these important procedures.

Key takeaways

The study aims to improve safety for breathing tube placement.
It focuses on 'awake intubation' using a flexible camera tube.
Researchers want to predict if procedures will be difficult before they start.
New tools will help doctors prepare better for tricky situations.
Participation involves sharing information from a planned medical procedure.

Who may be eligible?

This study is looking for adult patients who are already planned to have an awake intubation using a flexible bronchoscope because their doctors expect it might be difficult to place a breathing tube.

You can take part if you are 18 years old or older and are scheduled for this specific type of intubation. You also need to understand the study and agree to participate by giving your consent.

However, you cannot join the study if you are not already scheduled for an awake intubation with a flexible bronchoscope. Pregnant or breastfeeding individuals are also not able to participate, nor are those who do not give their consent.

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 an 'awake intubation with a flexible bronchoscope'?
Are you able to agree to take part in the study?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you won't need extra visits or assessments beyond what your medical care already requires. The study will mainly involve doctors collecting information during and after your planned awake intubation with a flexible bronchoscope. This information will include details about how the procedure went and how difficult it was. There are no additional medications, follow-up appointments, or long-term commitments specifically for this research. Your participation is focused on allowing the research team to gather data from your routine medical procedure to help them develop better prediction tools. The total duration of your involvement would be during and immediately after your planned intubation.

Potential risks and benefits

A potential benefit of taking part is contributing to medical knowledge that could make awake intubation procedures safer and more predictable for future patients. There are no additional physical risks from participating in this study beyond the standard risks associated with your planned awake intubation procedure itself, as it primarily involves data collection. You have the right to withdraw from the study at any time without affecting your medical care. Your decision to participate or not will not impact the quality of treatment you receive.

Locations (1)

University Medical Center Hamburg-Eppendorf
Verified postcode
Hamburg, Germany· Recruiting

Common questions

What is an 'awake intubation'?

It's when doctors put a breathing tube into your windpipe while you are awake, but numb and comfortable, especially if putting you to sleep first would be too risky.

What is a 'flexible bronchoscope'?

It's a thin, flexible tube with a camera that doctors use to see inside your windpipe and help place the breathing tube safely.

Why is this research important?

It aims to create better tools for doctors to predict if an awake intubation will be difficult, making the procedure safer and smoother for patients.

Will I receive new medicine if I join?

No, this study doesn't involve any new medicines. It focuses on collecting information during your already planned procedure.

Does taking part affect my medical care?

No, your medical care will remain exactly the same whether you choose to join the study or not.

How to find out more

Martin Petzoldt, MD, FEAMS

m.petzoldt@uke.de 04915222815932 Official trial record

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