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RecruitingPHASE2, PHASE3INTERVENTIONAL

Volatile Sedation for Patients With the Acute Respiratory Distress Syndrome

This study is investigating how two different types of routine sedation affect patients who are very unwell and need help breathing from a machine in intensive care. Patients often need sedation to be comfortable and safe when on a ventilator. Most commonly, this is given directly into a vein (intravenous or IV). However, another type of sedation, which involves breathing in special gases (like those used for general anaesthesia), is becoming more common and has recently been approved for use in the UK. We want to see how these two methods compare in terms of helping patients breathe on their own and protecting their lungs. We'll be carefully measuring breathing efforts and lung function to understand the potential benefits and drawbacks of each type of sedation.

At a glance

Status
Recruiting
Phase
PHASE2, PHASE3
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Enrolment target
20
Start
01 Nov 2023
Estimated completion
31 Jul 2027

What is this study about?

When patients are very poorly and need a breathing machine (ventilator) in intensive care (ICU), they often need medication to help them stay comfortable and safe. This medication is called sedation. Usually, sedation is given by a drip directly into a vein. However, there's another way to give sedation, which involves breathing in special gases – similar to the 'gas' used when you have a general anaesthetic for an operation.

Being on a breathing machine can save lives, but it's important that the patient's own breathing works well with the machine. Sometimes, the machine does all the work, but often, patients can make some breathing efforts themselves. This study wants to find out if inhaled sedation helps the lungs more and allows patients to breathe more naturally compared to the usual IV sedation. We know that inhaled sedation might not stop patients' natural breathing as much, which could be a good thing for their recovery. However, we need to make sure that any extra breathing efforts aren't too much or harmful to already damaged lungs.

In this study, we'll be carefully comparing these two types of sedation. We'll look at patients who are already receiving standard IV sedation and then, for a short period (six hours), switch them to inhaled sedation while carefully monitoring their breathing and lung health. After this, they'll go back to their original IV sedation. This helps us see the direct effect of each sedation type on the same person. The main goal is to understand which type of sedation best supports patients' breathing and protects their lungs when they have a serious lung condition called Acute Respiratory Distress Syndrome (ARDS).

Key takeaways

  • This study compares two types of sedation (IV vs. inhaled) for critically ill patients.
  • It aims to find out which sedation best supports breathing and protects the lungs.
  • Patients will be on a ventilator for a serious lung condition called ARDS.
  • The study involves a temporary switch from IV to inhaled sedation, then back again.
  • Careful measurements of breathing and lung function will be taken.
  • The goal is to improve care for patients needing breathing support in intensive care.

Who may be eligible?

This study is looking for adults who are currently in intensive care and have a serious lung condition called Acute Respiratory Distress Syndrome (ARDS). To take part, you would need to be on a breathing machine (ventilator) and already making some breathing efforts on your own, rather than the machine doing all the work. You should also be receiving sedation through a drip (IV sedation) and expected to remain on the breathing machine and this level of sedation for at least another 24 hours.

You wouldn't be able to join the study if you have a personal or family history of a specific reaction to anaesthetics called malignant hyperpyrexia, or if doctors suspect you have increased pressure inside your head. Other reasons you might not be suitable include if you're receiving very high doses of certain medications to support your blood pressure, if you're pregnant, or if you're taking very high doses of certain oral sedatives or pain medications that could affect your breathing.

Also, if you have certain problems with your food pipe (oesophagus) or upper stomach, or if doctors plan to temporarily stop your sedation or change your breathing machine settings soon, you wouldn't be able to participate. This is because we need your condition and sedation to be stable to get clear results from the study.

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 an adult currently in intensive care?
  2. Do you have a serious lung condition called ARDS?
  3. Are you on a breathing machine (ventilator) and making some breathing efforts yourself?
  4. Are you receiving sedation through a drip (IV)?
  5. Are you expected to remain on the breathing machine and stable for at least another 24 hours?
  6. Do you have any conditions like pregnancy or certain stomach/food pipe problems?
Answer every question to see your result.

What does participation involve?

If you take part in this study, you will stay in the Intensive Care Unit (ICU) as usual. The main part of the study involves a change in your sedation for a short period. You will start by receiving your usual sedation through a drip into your vein. We will then switch you to inhaled sedation (breathing in gases) for about six hours. During this time, and before and after, we will take careful measurements of your breathing and how your lungs are working. This might involve additional monitoring equipment, but nothing that would be uncomfortable or involve new procedures beyond what's already done in ICU. After six hours, you will return to your original IV sedation. The total duration of the specific study measurements and changes in sedation will be about 12-18 hours. There are no additional hospital visits or long-term follow-up beyond your usual ICU care.

Potential risks and benefits

Participating in this study might offer a potential benefit by helping us understand which type of sedation works best for patients with severe lung conditions. This could lead to better care in the future. The risks involve being switched between two types of sedation, both of which are commonly used in hospital settings. We will monitor you very closely throughout the study to make sure you are comfortable and safe. You always have the right to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Guy's & St Thomas' NHS Foundation Trust
    Verified postcode
    London, United Kingdom· Recruiting

Common questions

What is ARDS?

ARDS stands for Acute Respiratory Distress Syndrome. It's a serious lung condition where fluid builds up in the lungs, making it very difficult to breathe without help.

What is a ventilator?

A ventilator is a machine that helps you breathe when your lungs are too sick to do it on their own. It's also called a breathing machine.

Will I be awake during the study?

You will be sedated, which means you will be in a comfortable, sleepy state throughout the study, similar to how you usually are in intensive care. The goal is your comfort and safety.

Is inhaled sedation safe?

Yes, inhaled sedation is a recognised medical technique, similar to the gases used for general anaesthesia, and has recently been approved for use in the UK. It will be carefully managed by medical staff.

How long does the study last for each patient?

The specific part of the study where we change sedation and take measurements lasts about 12-18 hours in total for each patient.

How to find out more

Guy Glover

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 "Volatile Sedation for Patients With the Acute Respiratory Di…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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