Active not recruitingOBSERVATIONAL

PupillOmetry for Prediction of DelirIUM

This study is investigating a new tool called 'automated pupillometry' (AP) to see if it can predict when seriously ill patients in intensive care (ICU) might develop delirium. Delirium is a state of severe confusion that can be very distressing and lead to serious problems, including longer hospital stays and poorer recovery. Currently, identifying delirium can be difficult and time-consuming. The AP device quickly and objectively measures how a patient's pupils react to light. Researchers believe that certain changes in these reactions could be an early sign of delirium. The study aims to see if measuring these eye responses on the third day of mechanical ventilation can help doctors predict delirium during the first two weeks in the ICU. This could allow for earlier interventions and better support for patients.

At a glance

Status

Active not recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

213

Start

15 Apr 2022

Estimated completion

01 Mar 2026

Delirium ICU

What is this study about?

When patients are very ill in intensive care (ICU), they can sometimes develop a serious condition called delirium. This is a state of severe confusion that can make patients agitated, hallucinate, or become very drowsy and unresponsive. It can be a frightening experience for both patients and their families. Delirium isn't just distressing; it can also lead to other problems like accidentally removing tubes, staying in the hospital longer, and even affecting a patient's long-term recovery and memory.

Current ways to check for delirium involve nurses or doctors observing patients and using special checklists. While helpful, these methods can take time and require specific training, meaning delirium might not always be spotted early enough. This study is exploring a new, quicker way to predict delirium using a device called an automated pupillometer (AP). This device is like a clever scanner that quickly and accurately measures how your pupils (the black circles in the centre of your eyes) react to light.

The idea is that changes in how your pupils react might be an early sign that your brain is having trouble, and that you might be at risk of developing delirium. Researchers hope that by measuring these pupil responses, especially on the third day after a patient starts using a breathing machine (mechanical ventilation), they can identify patients who are likely to develop delirium during their first two weeks in the ICU. If this works, doctors could then adjust a patient's care sooner to try and prevent or lessen the severity of delirium.

Key takeaways

Tests a new eye scanner to predict delirium in ICU patients.
Delirium is serious confusion that affects many critically ill patients.
The scanner measures how pupils react to light, looking for early warning signs.
Participation involves painless eye measurements, no changes to medication.
Aims to improve early detection and care for patients at risk of delirium.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

This study is looking for adult patients who are 18 years old or older. You would need to have been on a breathing machine (mechanical ventilation) for at least two days before joining. The researchers also need to get permission from you or your close family to include you in the study.

There are several reasons why someone might not be able to join. For example, if you are already confused when the study starts, or if you have certain eye conditions that affect how your pupils react to light. Patients with particular brain injuries or conditions, like a severe head injury or advanced dementia, would also not be able to participate. Also, if you've already been in intensive care for more than three days, or on a breathing machine for more than three days, you wouldn't be eligible. The study is also not for patients who are very near the end of their life, or who are under guardianship or lack social security affiliation.

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?
Have you been on a breathing machine (ventilator) for at least 48 hours?
Do you or your family agree to take part?
Are you currently not confused, according to the doctors?
Do you have certain eye or brain conditions that might prevent you from joining?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, the researchers will use the automated pupillometer device to measure your pupil responses twice daily for up to seven days, starting from the day you join the study. This is a simple, quick, and non-invasive measurement. During this time, the medical team will also continue to check for delirium using their standard methods. There are no changes to your medication or other treatments; this study simply involves extra observation and measurements. The researchers will then follow your progress for up to three months after you join.

Potential risks and benefits

As this is an observational study, it does not involve any new treatments or interventions, meaning there are no direct medical risks from participating. The pupillometry measurements are quick and painless. The main potential benefit is that the findings from this study could help improve the diagnosis and management of delirium for future patients. Understanding more about how to predict delirium could lead to earlier support and potentially better outcomes. You are always free to withdraw from the study at any time without giving a reason, and this would not affect your medical care in any way.

Locations (1)

Hôpital Bichat-Claude Bernard
Verified postcode
Paris, France

Common questions

What is delirium?

Delirium is a serious state of confusion that can happen to very ill patients, especially in intensive care. It can make you agitated or drowsy.

What is a 'pupillometer'?

It's a small device that quickly and gently scans your eye to measure how your pupils (the black part in the centre of your eye) react to light. It's painless.

Will taking part change my treatments?

No, this study is observational. Your medical team will continue to give you the best care, and your treatments will not change because of the study.

Why is this study important?

It could help doctors find a faster way to predict delirium, allowing them to help patients at risk sooner, potentially leading to better recovery.

Can I stop participating if I want to?

Yes, you or your family can decide to withdraw from the study at any time, for any reason, and it won't affect your medical care.