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International obServational sTudy on AiRway manaGement in operAting Room and Non-operaTing Room anaEsthesia

This international study, called STAR GATE, is looking at how doctors worldwide manage a patient's breathing tube during general anaesthesia. This includes both operations in the operating theatre and procedures done elsewhere in the hospital. The main goal is to find out how often serious but rare problems happen, like the heart struggling or oxygen levels dropping too low, during this process. They also want to see the different ways doctors manage breathing tubes around the world. By gathering this information from many patients, researchers hope to improve safety and care for everyone who needs general anaesthesia in the future.

At a glance

Status
Recruiting
Sponsor
University of Turin, Italy
Enrolment target
10,500
Start
15 Jan 2024
Estimated completion
01 May 2025

What is this study about?

When you have a general anaesthetic for an operation or other medical procedure, doctors need to make sure you can breathe properly. This often means inserting a special breathing tube. While this is usually very safe, sometimes problems can happen. This study is exploring how often these serious problems occur and why.

The STAR GATE study is watching how anaesthetists manage breathing tubes in adults having general anaesthesia. This covers all sorts of procedures, whether it's a planned surgery or an emergency, and whether it's in an operating room or another part of the hospital. The researchers are particularly interested in serious events that can happen, such as your heart struggling, or your body not getting enough oxygen.

The main idea is to get a clearer picture worldwide of what happens during this crucial part of anaesthesia. By understanding the current situation and the different methods doctors use, they hope to find ways to make managing breathing tubes even safer and improve patient care for everyone undergoing general anaesthesia.

Key takeaways

  • It's an international study about general anaesthesia.
  • It focuses on managing breathing tubes during operations and procedures.
  • The goal is to understand how often serious problems like heart issues or low oxygen levels occur.
  • It's an 'observational' study, meaning your treatment won't change.
  • Learning more could help improve safety for future patients.
  • Only adults (18+) having a breathing tube for anaesthesia can take part.

Who may be eligible?

You might be able to take part in this study if you are an adult, aged 18 or over, and will be having general anaesthesia where a breathing tube is used. This applies whether your procedure is in an operating theatre or another area of the hospital.

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.

  1. Are you 18 years old or older?
  2. Are you having general anaesthesia for a procedure?
  3. Will a breathing tube be used as part of your anaesthesia?
  4. Is this not an emergency resuscitation situation?
  5. Are you not critically ill with a breathing tube already in place?
Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't need any extra appointments or tests beyond your usual medical care. The study is observational, meaning the healthcare staff will simply record information about your general anaesthesia and how your breathing tube was managed. This information will only be collected if you are already having general anaesthesia as part of your treatment. The study team will track if any of the specific problems they are looking for occur during your anaesthesia. You will not receive any study medication. The data collection will happen during and shortly after your anaesthesia, up to the start of your surgery. Your participation will not involve any additional follow-up beyond your standard hospital care.

Potential risks and benefits

This study is observational, which means your medical care will not change because of it. There are no direct benefits to you from taking part, as it's about collecting information for future treatments. Your medical team will still provide the best care for you. The main risk is that your personal information, carefully managed to protect your privacy, might be accessed, though strict rules are in place to prevent this. You always have the right to decide not to take part or to withdraw from the study at any time without it affecting your medical treatment.

Locations (10)

  • University of Texas Southwestern Medical Center
    Verified postcode
    Dallas, United States· Not yet recruiting
  • MD Anderson Cancer Center
    Verified postcode
    Houston, United States· Not yet recruiting
  • Cochin University Hospital, Assistance Publique - Hôpitaux de Paris
    Verified postcode
    Paris, France· Recruiting
  • Tata Memorial Hospital
    Verified postcode
    Mumbai, India· Not yet recruiting
  • University Hospital of Galway
    Verified postcode
    Galway, Ireland· Not yet recruiting
  • Fondazione IRCCS San Gerardo dei Tintori
    Verified postcode
    Monza, Italy· Not yet recruiting
  • Azienda Ospedaliera Universitaria San Luigi Gonzaga
    Verified postcode
    Orbassano, Italy· Not yet recruiting
  • A.O.U. Città della Salute e della Scienza
    Verified postcode
    Torino, Italy· Recruiting
  • ASST Grande Ospedale Metropolitano Niguarda
    Verified postcode
    Milan, Italy· Completed
  • Ospedale Santa Chiara, APSS Trento
    Verified postcode
    Trento, Italy· Recruiting

Common questions

What is 'airway management'?

It's how doctors make sure you can breathe properly during general anaesthesia, often by putting in a special breathing tube.

What kind of problems are they looking for?

They're interested in rare but serious issues like a sudden drop in blood pressure (cardiovascular collapse), the heart stopping (cardiac arrest), or dangerously low oxygen levels.

Will my treatment change if I join this study?

No, your medical care will be exactly the same whether you take part or not. This study just observes and records information.

Do I need to do anything extra if I participate?

No, you don't need to do anything extra. The study team will collect information from your medical records during and after your anaesthesia.

Who is running this study?

This is an international study involving many hospitals around the world, looking at common practices in anaesthesia.

How to find out more

Vincenzo Russotto, MD

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

Interested in taking part?

Register your interest

Share your details and the research team for "International obServational sTudy on AiRway manaGement in op…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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