RecruitingOBSERVATIONAL

Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation

This research is investigating a common problem in critically ill patients, especially those with severe liver disease called cirrhosis, who need help breathing with a machine. The study aims to understand if increased pressure inside the belly (which doctors call intra-abdominal hypertension) can make it more likely for tiny amounts of stomach fluid or food to get into the lungs. This accidental entry of fluid into the lungs, known as microaspiration, can cause serious complications. By comparing patients with and without this high tummy pressure, researchers hope to learn more about this connection. The main goal is to improve care for these very vulnerable patients by better understanding the risks they face.

At a glance

Status

Recruiting

Sponsor

University Hospital, Lille

Enrolment target

226

Start

08 Oct 2021

Estimated completion

01 Dec 2026

Critical Illness Cirrhosis, Liver

What is this study about?

This study is focused on very unwell adults who have severe liver scarring, known as cirrhosis, and are in hospital needing a breathing machine. Doctors are looking into a specific problem called 'intra-abdominal hypertension' (IAH), which simply means there's too much pressure building up inside the belly or tummy area. This can happen for various reasons and can make sick people even sicker.

The main aim of this research is to see if there's a connection between this high pressure in the belly and something called 'microaspiration'. Microaspiration happens when tiny, sometimes unnoticeable, amounts of fluid from the stomach or throat accidentally go down the wrong way into the lungs. In very sick patients, especially those on breathing machines, even tiny amounts of fluid in the lungs can cause serious problems like infections.

By understanding if high pressure in the belly makes microaspiration more likely, doctors hope to find better ways to care for these critically ill patients. This knowledge could help them prevent complications and improve the chances of recovery for people with cirrhosis who are on breathing machines. It's about finding out more so they can offer the best possible treatment.

Key takeaways

The study looks at pressure in the belly and lung problems in very sick patients.
It focuses on adults with severe liver disease (cirrhosis) on breathing machines.
Researchers want to see if high belly pressure leads to tiny bits of stomach fluid entering the lungs.
Participation involves routine monitoring of belly pressure and taking samples from the breathing tube for two days.
The goal is to improve understanding and future care for critically ill patients.
There are no new treatments or medications involved in this study.

Who may be eligible?

To take part in this study, you would need to be an adult patient who has liver scarring (cirrhosis) and is currently on a breathing machine in hospital.

There are also some reasons why you wouldn't be able to join. For example, if you are pregnant, or if your kidneys are not producing enough urine (a condition called oliguria). Also, if doctors can't safely check the pressure inside your bladder – which is how they measure the pressure in your tummy – then you wouldn't be able to participate.

The study is open to both men and women aged 18 to 99 years old who meet the other requirements.

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 an adult (18 years or older)?
Do you have a condition called cirrhosis (liver scarring)?
Are you currently on a breathing machine (mechanical ventilation)?
Are you NOT pregnant?
Are your kidneys producing enough urine?
Can doctors safely measure pressure inside your bladder?

Answer every question to see your result.

What does participation involve?

If you or your loved one were to join this study, it would involve some extra monitoring while you are already in hospital and on a breathing machine. Doctors would check the pressure inside your bladder every 8 hours for the first two days you are on the breathing machine. This is a routine way to measure pressure inside the tummy area.

In addition, doctors would take small samples from the tube in your windpipe (trachea) which is part of being on a breathing machine. These samples would be checked for tiny amounts of stomach fluids to see if microaspiration is happening. There are no extra medications or follow-up visits specifically for this study once you are off the breathing machine or discharged from critical care. The total duration of the study's specific procedures for each patient would be only for the first two days of being on the breathing machine.

Potential risks and benefits

The potential benefits of taking part in this study are indirect; by helping researchers learn more about a common problem in very sick patients, you could contribute to better care for future patients with similar conditions. There are no direct personal health benefits. The risks involved are minimal as the study mainly uses monitoring procedures that are already part of standard care for critically ill patients, such as measuring bladder pressure and taking samples from the breathing tube. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Hop Claude Huriez Chu Lille
Verified postcode
Lille, France· Recruiting
Hop Salengro - Hopital B
Verified postcode
Lille, France· Recruiting

Common questions

What is 'cirrhosis'?

Cirrhosis is a serious condition where your liver is badly scarred and damaged, making it difficult for it to work properly.

What does being 'on a breathing machine' mean?

It means a machine is helping you breathe when you are very ill and cannot breathe well enough on your own. This is also called mechanical ventilation.

What is 'intra-abdominal hypertension'?

This is when there is too much pressure inside your belly area, which can happen for various reasons if you are very unwell.

What is 'microaspiration'?

It's when tiny amounts of fluid, like stomach contents, accidentally get into your lungs. It can sometimes cause problems like lung infections.

Will I get new treatments in this study?

No, this study is about understanding a problem, not testing new treatments. It involves extra monitoring of things routinely checked in hospital.

How to find out more

Saad Nseir, MD,PhD

saadalla.nseir@chru-lille.fr 0320444495 Official trial record

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