RecruitingOBSERVATIONAL

Microvascular Monitoring in Circulatory Shock and Sepsis (MiMICSS)

This study, called MiMICSS, is exploring a new, gentle way to check on critically ill patients in intensive care, especially those with serious infections like sepsis or who are in shock. Researchers are using a special device called NIRS, which shines a safe, near-infrared light on the patient's skin, over their muscles and brain. This helps them see how well blood is flowing in the body's smallest blood vessels. The main aim is to find out if this monitoring method is practical to use over time and if the information it provides can help doctors better understand and treat these very unwell patients. It's hoped that this research could lead to improved monitoring and potentially better outcomes for patients in the future.

At a glance

Status

Recruiting

Sponsor

University of Manitoba

Enrolment target

100

Start

27 May 2022

Estimated completion

31 May 2026

Sepsis Shock Critical Illness

What is this study about?

When someone is very unwell and in intensive care, perhaps with a serious infection called sepsis or in a state of shock, their body's tiniest blood vessels – called microvessels – might not be working as they should. These tiny vessels are crucial because they deliver oxygen and nutrients to all parts of the body. If they're not working well, it can make patients even sicker.

This study, called MiMICSS, wants to see if a special device can help doctors understand what's happening with these microvessels. The device uses something called Near-Infrared Spectroscopy, or NIRS for short. It's a bit like shining a harmless light (like a very dim lightbulb) onto the skin, over a muscle or the brain. This light can tell researchers how much oxygen is in the blood in those tiny vessels, giving them a real-time picture of blood flow.

The main goal of this research is to figure out if using this NIRS device is practical and helpful for patients in intensive care. They want to see if they can use it over several days to track changes in blood flow and if the information gathered can help doctors get a better idea of how a patient is doing. Ultimately, they hope this research could lead to new ways to monitor and improve care for critically ill patients in the future.

Key takeaways

This study explores a new, gentle way to monitor critically ill patients in intensive care.
It uses a special light on the skin to check blood flow in tiny vessels.
Taking part involves wearing harmless sensors; no new treatments or medications.
The goal is to improve understanding and potentially future care for conditions like sepsis.
Participation is voluntary, and you can withdraw at any time.
There are no direct personal benefits from taking part, but it helps medical research.

Who may be eligible?

To take part in this study, you would need to be an adult (18 years or older) and currently admitted to an intensive care unit (ICU). You would also need to be using a breathing machine (mechanical ventilation) to help you breathe.

There are some reasons why you wouldn't be able to join the study. For example, if you are very overweight (with a BMI over 40) or if more than 24 hours have already passed since you were admitted to the ICU. You also couldn't take part if a doctor believes you are likely to die within the next 24 hours, or if you have a known allergy to the materials in the monitoring device.

Other reasons for not being able to join include if you have severe yellowing of the skin (jaundice), significant bruising, or if you have recently tested positive for COVID-19. Lastly, if your doctor thinks it's not in your best interest, or if you (or a family member acting on your behalf) decide not to give permission, you wouldn't be able to participate.

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?
Are you currently in intensive care?
Are you receiving help with breathing from a machine?
Were you admitted to ICU less than 24 hours ago?
Do you not have severe yellow skin colouring or significant bruising?
Have you not recently tested positive for COVID-19?

Answer every question to see your result.

What does participation involve?

If you agree to take part in this study, the research team will apply special NIRS sensors to your skin, over a muscle and on your head. These sensors are gentle and non-invasive, meaning they don't involve needles or cuts. They will stay on for a period of time during your stay in intensive care while you are receiving standard medical care.

The NIRS monitors will continuously collect information about the blood flow in your tiny vessels. Researchers will also regularly record your vital signs (like heart rate and blood pressure) directly from your existing ICU monitors and gather other medical information from your patient notes. This study involves no additional treatments or changes to your usual care, just the extra monitoring with the NIRS devices. The total duration of your participation will depend on how long you are in intensive care, but the monitoring will be ongoing during that time.

Potential risks and benefits

There are no direct benefits to you from taking part in this study, but your participation could help doctors learn more about critical illness, potentially improving care for future patients. The risks are very low, as the NIRS device is safe and non-invasive, meaning no needles or medications are involved beyond your usual care. The main discomfort might be the feel of the sensing pads on your skin, and there's a very slight chance of skin irritation, especially if you have sensitive skin or allergies to textiles. Remember, you can choose to stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Health Sciences Centre Winnipeg
Verified postcode
Winnipeg, Canada· Recruiting

Common questions

What is NIRS?

NIRS stands for Near-Infrared Spectroscopy. It's a device that shines a harmless light onto your skin to measure blood flow and oxygen levels in tiny blood vessels, without any pain or needles.

Will this study change my medical treatment?

No, taking part in this study will not change any of your current medical treatments or care. You will continue to receive the standard care your doctors believe is best for you.

Is the NIRS device painful?

No, the NIRS device is completely painless. It just involves placing a small sensor pad gently on your skin, similar to a sticky plaster.

How long will I be monitored?

The NIRS monitoring will be ongoing throughout your stay in the intensive care unit, as long as you remain in the study and meet the criteria.

Can I leave the study if I change my mind?

Yes, you or your authorised representative can withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

Asher Mendelson, MD, PhD

asher.mendelson@umanitoba.ca 2047871634 Official trial record

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