All studies
CompletedObservational

To determine if critically ill patients with acute respiratory failure treated with carbocisteine, hypertonic saline, or both, experience increased hydration of airway mucus.

When someone is severely ill in an intensive care unit (ICU), their lungs may struggle to work. They often need a breathing machine, called a ventilator, to keep them alive. However, being on a ventilator makes it hard to cough up sticky lung secretions (phlegm), which can cause chest infections and delay recovery. This study is part of a larger UK project called the MARCH trial. It looks at two treatments: carbocisteine (given via a feeding tube) and hypertonic saline (a salty water mist inhaled into the lungs). Researchers will collect and test small samples of phlegm from patients already taking part in the MARCH trial. They want to find out if these medicines make phlegm thinner, wetter, and easier to clear. The results will help doctors choose the best treatments to help critically ill patients get off breathing machines faster.

At a glance

Status
Completed
Sponsor
Queen's University Belfast
Enrolment target
360
Start
01 Aug 2022
Estimated completion
30 Apr 2025

What is this study about?

When people become critically ill, their lungs can sometimes stop working properly. This condition is called acute respiratory failure. Patients with lung failure need urgent treatment in an intensive care unit (ICU) and often rely on a breathing machine (ventilator) to push oxygen into their lungs. While ventilators are life-saving, they make it difficult for patients to clear their airway secretions naturally. Over time, thick, sticky phlegm can build up, blocking the airways and increasing the risk of serious lung infections.

To help solve this problem, doctors sometimes prescribe medicines known as 'mucoactives'. These are designed to loosen and thin out phlegm. This study focuses on two treatments: carbocisteine, which is given as a liquid or powder through a feeding tube, and hypertonic saline, which is a sterile salty water mist breathed in through a mask or breathing tube. A major UK study called MARCH is currently testing whether these medicines help patients recover faster so they can be taken off ventilators sooner.

This study, called EME, works alongside the main MARCH trial. By collecting small samples of airway mucus that are removed during routine ICU care, scientists will test how thick, sticky, and inflamed the phlegm is under different treatments. The goal is to understand the exact biological ways these medicines hydrate and break down mucus. This valuable information will help doctors prescribe the right doses and choose the best future therapies for people fighting life-threatening lung conditions.

Key takeaways

  • The study tests whether carbocisteine and salty water mist help thin lung secretions in critically ill patients.
  • It is a sub-study of the larger UK-wide MARCH clinical trial.
  • Participation involves testing phlegm samples that are already collected during standard ICU nursing care.
  • There are no extra clinic visits or uncomfortable procedures required.
  • The goal is to help patients recover faster and spend less time on breathing machines.

Who may be eligible?

This study is open to patients aged 16 and older who are critically ill in an intensive care unit, need a ventilator to help them breathe, and are already taking part in the main MARCH clinical trial.

Because patients on ventilators are often sedated or too unwell to speak for themselves, consent is usually discussed with a close family member or legal representative. This ensures the patient's known wishes and best interests are fully respected.

Patients cannot take part if they have suspected or confirmed COVID-19, or if they do not meet the entry rules for the main MARCH study. The hospital care team will check all criteria before inviting anyone to join.

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. The patient is aged 16 or older.
  2. The patient is currently in an intensive care unit (ICU).
  3. The patient requires a ventilator (breathing machine) to help them breathe.
  4. The patient is already enrolled in the main MARCH trial.
  5. The patient does not have suspected or confirmed COVID-19.
Answer every question to see your result.

What does participation involve?

Because this study takes place in the intensive care unit, there are no extra hospital appointments or clinic visits. Taking part simply involves allowing the research team to collect small samples of phlegm while the patient is receiving care on a breathing machine.

Nurses routinely clear mucus from breathing tubes as part of standard ICU care. For this study, some of this collected phlegm will be sent to a specialist laboratory rather than being thrown away. Patients will be receiving carbocisteine, hypertonic saline, both, or standard care as decided by the main MARCH trial. Sample collection continues only while the patient requires a breathing tube, and their overall medical care will not be interrupted or delayed.

Potential risks and benefits

Patients may not experience any direct personal benefit from having their phlegm tested, but the study will help doctors improve future treatments for critically ill patients with lung failure. Researchers do not expect any extra physical risks or discomfort from this sub-study, as the samples are collected during normal, necessary airway cleaning. As with any clinical trial, a family member or representative can choose to withdraw the patient from the study at any time without giving a reason, and this will never affect the quality of care they receive.

Locations (31)

  • Royal Victoria Hospital
    Approximate
    Belfast, Northern Ireland
  • Bristol Royal Infirmary
    Approximate
    Bristol, England
  • Sunderland Royal Hospital
    Approximate
    Sunderland, England
  • Belfast City Hospital
    Approximate
    Belfast, Northern Ireland
  • Royal Infirmary of Edinburgh at Little France
    City only
    Lothian, Scotland
  • Royal Liverpool University Hospital NHS Trust, Royal Liverpool University Hospital, Prescot Street, Liverpool, L7 8XP
    Verified postcode
    Liverpool, England
  • Royal Cornwall Hospitals NHS Trust
    Unverified
    Truro, England
  • Mersey Care NHS Trust at Aintree Hospital
    Unverified
    Liverpool, England
  • Manchester Royal Royal Infirmary
    Unverified
    Manchester, England
  • Wythenshawe Hospital
    Unverified
    Manchester, England
  • Western General Hospital
    Unverified
    Lothian, Scotland
  • Royal Stoke University Hospital
    Unverified
    Stoke-on-trent, England

Common questions

What is a mucoactive medication?

It is a type of medicine designed to break down thick, sticky phlegm in the lungs so it can be cleared more easily.

Will taking part cause any pain or discomfort?

No. The phlegm samples are taken during routine suctioning that nurses already perform to keep the patient's breathing tube clear.

Who decides if a critically ill patient can join?

Because patients on ventilators are usually sedated, doctors will ask a family member or legal representative for their agreement before enrolling them.

Can we change our minds later?

Yes. Consent can be withdrawn at any point without needing to give an explanation, and routine hospital care will continue as normal.

How long will the patient be in the study?

Samples are only collected while the patient is in the intensive care unit and needs help from a breathing machine.

How to find out more

Cliff Taggart

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

Discussion

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