RecruitingNAINTERVENTIONAL

Optimisation Strategy for Emergency Tracheal Intubation

This study aims to make emergency breathing tube insertion (called tracheal intubation) safer for adults who are very unwell and need help breathing. It's investigating a combination of three methods: using a specific muscle relaxant called rocuronium, providing gentle breathing with a mask before the tube is placed, and using a special soft guide (Gum Elastic Bougie or GEB) to help doctors put the tube in correctly. The main goal is to see if using all three together can reduce complications and improve safety during this urgent procedure. Researchers will collect information immediately after the procedure and again after 28 days to understand its effects, and they hope this new approach will significantly lower the risk of problems.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Bordeaux

Enrolment target

1,500

Start

14 Jan 2023

Estimated completion

01 Sep 2026

Emergencies Out-of-hospital Setting Tracheal Intubation

What is this study about?

When someone is very ill and can't breathe properly on their own, doctors sometimes need to insert a breathing tube into their windpipe. This is called tracheal intubation, and it's a very important procedure often done in emergencies.

This study is looking at a new, combined approach designed to make this emergency procedure safer for adults. Doctors already know that certain techniques can help. For example, gently helping someone breathe with a mask for a short time before placing the tube can reduce low oxygen levels. Also, using a specific type of muscle relaxant called rocuronium might lead to fewer problems after the tube is in, compared to another common drug. Finally, a flexible device called a Gum Elastic Bougie (GEB) can act as a guide to make it easier for doctors to put the tube in correctly, especially if there are challenges.

What's new about this study is that it's testing these three helpful techniques *together* for the first time. The researchers believe that by combining rocuronium, mask ventilation before the intubation, and using a GEB as a guide, they can significantly reduce problems that can sometimes happen during and after emergency breathing tube insertion. They will be carefully watching what happens to patients immediately after the procedure and then checking again about a month later to see how well this new strategy works.

Key takeaways

This study is about improving safety during emergency breathing tube placement.
It combines three techniques: a specific muscle relaxant, mask ventilation, and a tube guide.
The goal is to reduce problems during this critical emergency procedure.
It focuses on adults needing emergency breathing support outside of a hospital.
Data will be collected after the procedure to evaluate the strategy's effectiveness.

Who may be eligible?

This study is looking for adults aged 18 or older who are very unwell and need a breathing tube inserted in an emergency situation, typically outside of a hospital. This could be due to various serious conditions like injuries, severe breathing difficulties, being in a coma, drug overdoses, or being in shock. However, individuals who have had a heart attack and are in cardiac arrest would not be included.

There are some specific reasons why someone wouldn't be able to join the study. These include having known allergies or conditions that make using the study medications (like rocuronium or sugammadex) unsafe. Also, if someone can't safely receive gentle mask breathing before the procedure because they are actively being sick or coughing up blood, they wouldn't be able to take part.

Finally, the study cannot include pregnant or breastfeeding women, people who are under legal protection (like guardianship), or anyone who is not part of a medical aid scheme. This helps ensure everyone in the study can be properly cared for.

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?
Do you need a breathing tube because of a serious emergency outside of a hospital?
Do you have no known allergies to common emergency medicines like muscle relaxants?
Are you not pregnant, breastfeeding, or under legal guardianship?
Are you part of a medical aid scheme?

Answer every question to see your result.

What does participation involve?

If you were to take part in this study, it would happen during an emergency situation if doctors decide you need a breathing tube inserted. The specific strategy being tested would be used during this procedure. There are no extra visits or assessments specifically for the study beyond what would normally happen for your emergency care. Doctors will record information about your condition and the procedure immediately afterwards, while you are still out of the hospital. Then, about 28 days later, information from your medical records inside the hospital would be collected. Your total participation is essentially limited to the emergency procedure itself and the collection of data afterwards.

Potential risks and benefits

The potential benefit of taking part in this study is contributing to research that aims to make emergency breathing tube insertion safer for future patients. While there are no direct benefits to participants beyond standard emergency care, the goal is to reduce complications. As with any medical procedure, there are always some risks involved, but the techniques used in this study are based on established medical practices. You or your legal representative always have the right to withdraw from the study at any time, and this would not affect the quality of your medical care.

Locations (22)

CHU d'Angers
Verified postcode
Angers, France· Recruiting
CH Carnelle Portes de l'Oise
Verified postcode
Beaumont-sur-Oise, France· Recruiting
AP-HP - Hôpital Avicenne
Verified postcode
Bobigny, France· Recruiting
CHU de Bordeaux - Hôpital Pellegrin
Verified postcode
Bordeaux, France· Recruiting
CH de Pontoise René Dubos
Verified postcode
Cergy-Pontoise, France· Recruiting
AP-HP - Hôpital Henri Mondor
Verified postcode
Créteil, France· Recruiting
CHU de Dijon
Verified postcode
Dijon, France· Not yet recruiting
GH Eaubonne Montmorency Hôpital Simone VEIL
Verified postcode
Eaubonne, France· Recruiting
AP-HP - Hôpital Raymond Poincaré
Verified postcode
Garches, France· Recruiting
CHU de Grenoble - Hôpital Nord La Tronche
Verified postcode
La Tronche, France· Recruiting
CH de Versailles - Site André Mignot
Verified postcode
Le Chesnay, France· Not yet recruiting
HCL - Hôpital Edouard Herriot
Verified postcode
Lyon, France· Recruiting

Common questions

What is a breathing tube and why is it used?

A breathing tube (tracheal intubation) is a soft tube placed into your windpipe to help you breathe, usually when you're very unwell and can't breathe well enough on your own. It's often used in emergencies.

What does 'out-of-hospital setting' mean?

This means the study is focused on emergency situations that happen outside of a hospital, like at home, at work, or at the scene of an accident, before you get to the hospital.

What is rocuronium?

Rocuronium is a medicine that temporarily relaxes your muscles. It's used to help doctors insert the breathing tube more easily and safely.

What is a Gum Elastic Bougie (GEB)?

It's a special, flexible guide that doctors can use to help direct the breathing tube into your windpipe correctly, especially if the procedure is a bit tricky.

Will I know if I'm in the study?

In an emergency, your doctors will involve your family or legal representative in decisions if possible. Information about your care, including if you're part of this study, would be discussed with them.

How to find out more

Xavier COMBES, Pr

xavier.combes@chu-bordeaux.fr 05 56 79 49 47 Official trial record

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