Non-invasive Measurement of the Hypotension Prediction Index for the Reduction of Intraoperative Hypotension
This study aims to find out if a new, non-invasive device can help prevent low blood pressure during major operations like hip or knee replacements. Low blood pressure during surgery, called Hypotension, can sometimes lead to serious problems like kidney damage or heart injury after the operation. Currently, monitoring blood pressure during surgery often involves invasive methods or leaves gaps between readings. This new device, called ClearSight, uses advanced technology to continuously monitor and even predict low blood pressure up to 15 minutes before it occurs. The study wants to see if using this device to guide treatment will lead to fewer complications compared to standard care for patients aged 45 and over.
At a glance
What is this study about?
When you have a major operation, your medical team works hard to keep you safe and well. One important aspect is maintaining a healthy blood pressure level throughout the surgery. Sometimes, blood pressure can drop too low, a condition doctors call 'intraoperative hypotension'. While your care team closely monitors you, a sudden drop in blood pressure can sometimes lead to complications such as kidney problems or even heart issues after your operation.
Traditionally, blood pressure monitoring during surgery might involve a small tube in an artery (which is invasive) or taking readings every few minutes, leaving short "blind spots" in between. This study is exploring a new, less invasive approach using a device called ClearSight. This device continuously monitors your blood pressure without needing a needle in your artery. What's even more advanced is that it has a special feature called the Hypotension Prediction Index (HPI). This HPI uses smart computer analysis to actually predict when your blood pressure might drop too low – up to 15 minutes before it happens! This early warning could allow doctors to adjust your treatment sooner.
The main goal of this research is to see if using this new monitoring system and following its guidance can help reduce the number of people who experience low blood pressure during surgery, and in turn, lower the risk of complications like kidney damage or heart injury afterwards. The study will compare this new method to the standard care patients usually receive when they have major operations like hip or knee surgery.
Key takeaways
- Exploring a new way to prevent low blood pressure during surgery.
- Uses a non-invasive device (ClearSight) to predict blood pressure drops.
- Aims to reduce risks like kidney or heart problems after surgery.
- Focuses on patients having major trauma or orthopaedic surgery.
- Compares this new method to usual care.
Who may be eligible?
This study is looking for volunteers who are planning to have certain major operations, specifically major trauma or orthopaedic surgery. This includes procedures like hip or knee replacement, surgery on the pelvis, or operations on the spine. You must be at least 45 years old to be considered.
There are also some reasons why you might not be able to join the study. For example, if you already need invasive blood pressure monitoring for your surgery, if you're taking part in another research study, or if you are pregnant or breastfeeding, you wouldn't be eligible. Also, if your surgery doesn't involve controlled breathing assistance (mechanical ventilation), or if you have certain heart conditions like an irregular heartbeat (atrial fibrillation), you wouldn't be able to participate. Finally, if you have a known allergy to gelatin, that would also stop you from joining.
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 having a hip, knee, spine, or similar major bone/trauma surgery?
- Are you 45 years old or older?
- Are you not pregnant or breastfeeding?
- Do you not have an irregular heartbeat (atrial fibrillation)?
- Are you not already in another research study?
What does participation involve?
If you decide to take part, during your surgery, in addition to the usual care, your medical team would use the new ClearSight monitoring device. This device will continuously measure your blood pressure and other vital signs non-invasively through a finger sensor. The information from this device would then help your doctors make decisions about your care during the operation. After your surgery, the research team will collect information about your recovery, including any kidney or heart issues that might occur. The total duration of your participation would involve your hospital stay and follow-up during your recovery period after surgery.
Potential risks and benefits
Locations (1)
- Justus-Liebig-University of GiessenVerified postcodeGiessen, Germany· Recruiting
Common questions
What is 'intraoperative hypotension'?
This is simply the medical term for when your blood pressure drops too low during an operation.
What is the ClearSight device?
It's a special non-invasive monitor that continuously measures your blood pressure and can even predict when it might drop during surgery.
What kind of operations is this study for?
It's for major trauma or orthopaedic surgeries, such as hip or knee replacements, spine surgery, or pelvis operations.
Will I receive different care if I join the study?
You will receive the new monitoring alongside your standard care, which may help your doctors make more informed decisions during surgery.
Can I leave the study if I change my mind?
Yes, you are free to withdraw from the study at any point without it affecting your medical care.
How to find out more
Emmanuel Schneck, M.D.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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