RecruitingOBSERVATIONAL

Alert Frequency, Nurse, and Patient Satisfaction With a wCVSM Software Across Health Care Systems and Cultures

This international study is testing new wireless devices that constantly check a patient's vital signs, such as heart rate, breathing, and blood pressure, while they are in the hospital. Researchers want to see how often these devices send out alerts and if these alerts are accurate. They are also keen to hear what patients and nurses think about using this new technology. The goal is to understand how these systems work in different hospitals and cultures, improving patient care and making nurses' jobs easier by providing quick, reliable information. This is a pilot study, meaning it's a small-scale test before a larger study might happen.

At a glance

Status

Recruiting

Sponsor

Christian S. Meyhoff

Enrolment target

100

Start

26 Feb 2024

Estimated completion

31 Dec 2026

User Experience Postoperative Complications Acute Medical Conditions

What is this study about?

Imagine being in the hospital after an operation or for a sudden illness, and your doctors and nurses need to keep a close eye on your health. This study is looking at a new way to do just that – using wireless devices that continuously check your vital signs like your heart rate, how you're breathing, and your blood pressure. Instead of a nurse manually checking these every few hours, this system would do it all the time, right from a device attached to you.

The main idea is to see how well this new technology works in real-life hospital settings, across different countries like the UK, Germany, and the US. It's a bit like testing a new app on your phone; the researchers want to know if it does what it's supposed to do, if the alerts it sends out are helpful and correct, and importantly, if it makes things better for both the patients and the nurses caring for them.

After using these devices, patients will be asked to fill out a questionnaire to share their experience. Nurses who have cared for patients using this system will also share their thoughts. The information gathered will help make decisions about whether this new way of monitoring patients could be used more widely to improve safety and comfort in hospitals.

Key takeaways

New wireless devices will continuously monitor vital signs in hospital.
Study checks how well these devices work and how often they alert staff.
Patients and nurses will share their experience with the new technology.
Aims to improve patient monitoring and make nurses' jobs easier.
Participation is voluntary; you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult, 18 years or older, and expected to stay in the hospital for at least two days. You might be considered if you are having surgery that's expected to last more than two hours, or if you've been admitted to the hospital for a sudden illness and your vital signs (like heart rate or breathing) were a bit out of the usual range within the first 24 hours of being admitted. For example, if your breathing was faster or slower than normal, or your heart rate was particularly high or low.

However, there are reasons why you might not be able to take part. This includes if you have allergies to common medical plasters or silicone dressings, or if you have a pacemaker or another implanted heart device. You also need to be able to understand the study and agree to take part without any pressure. If doctors feel you might not be able to cooperate with the study's procedures, you might also not be eligible.

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?
Do you expect to stay in the hospital for at least 2 days?
Are you having surgery longer than 2 hours OR were your vital signs abnormal when you were admitted for a sudden illness?
Do you have any allergies to plaster or silicone?
Do you have a pacemaker or other implanted heart device?
Can you understand and agree to take part in the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would wear a special wireless device that continuously checks your vital signs for up to four days. This would happen after your surgery or when you are admitted for an acute medical condition, and continue until you leave the hospital. Don't worry, your vital signs would also still be checked by nurses in the usual way, so you'd have continuous monitoring from both the new device and standard hospital checks.

During and after this time, you would be asked to fill out a questionnaire about your experience with the wireless monitoring system. Nurses who care for patients using these devices will also complete a questionnaire. The total maximum duration of the monitoring would be four days per patient, and you'd only need to complete that one questionnaire. It's an easy way for your feedback to help shape future hospital care.

Potential risks and benefits

Taking part in this study may offer the benefit of having your vital signs continuously monitored with a new wireless device, providing more frequent updates on your health status. Whilst there are no major known risks associated with wearing these devices, some people might experience mild skin irritation from the sensors, especially if they have sensitive skin. All devices used are already approved for medical use. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Cleveland Clinic Foundation, General Anesthesiology
Verified postcode
Cleveland, United States· Not yet recruiting
Universitätsklinikum Hamburg-Eppendorf (UKE), Zentrum für Anästhesiologie und Intensivmedizin, Klinik und Poliklinik für Anästhesiologie
Verified postcode
Hamburg, Germany· Completed
University Medical Center Groningen, Department of Anesthesiology
Verified postcode
Groningen, Netherlands· Recruiting
St. Olavs Hospital HF, Klinikk for anestesi og intensivmedisin
Verified postcode
Trondheim, Norway· Completed
Liverpool University Hospitals NHS Foundation Trust
Verified postcode
Liverpool, United Kingdom· Not yet recruiting

Common questions

What are vital signs?

Vital signs are basic measurements of your body's most essential functions, like your heart rate (how fast your heart beats), breathing rate, blood pressure, and oxygen levels.

Will this new monitoring replace my usual nursing care?

No, absolutely not. The wireless monitoring is an extra layer of observation. Your nurses will still check your vital signs and care for you in the standard way.

What kind of devices will I wear?

You will wear wireless sensors, similar to patches, that stick to your skin to measure things like your heart rate and breathing. These are safe and already approved for medical use.

What happens if an alert goes off?

If an alert happens, it means your vital signs might be outside the normal range. Your healthcare team, who will be monitoring the results, will be notified and can check on you promptly.

Will my information be kept private?

Yes, all your personal and health information collected during the study will be kept strictly confidential and anonymous, meaning your name won't be linked to your data when results are shared.

How to find out more

Katja K Head of Clinical, MD

katja.groenbaek@ward247.com 004528781188 Official trial record

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