Respiratory OBservation Using Ultra-Sensitive nanoTechnology

Официальное название

Respiratory Observation Using Ultra-Sensitive Nanotechnology

Обзор

The Problem - About one in three patients get even more sick while they are in hospital. This often happens because of chest infections, sepsis (very serious infection), or heart problems. These illnesses can make it hard to breathe. They are even more dangerous when patients already have breathing problems. Nurses and doctors need to spot when someone is getting worse as early as possible, so they can help them. For example, giving medicines quickly for sepsis can save lives. Sometimes it's hard to tell when someone is getting worse. Sometimes it's noticed too late. This can be very dangerous. In 2023, nearly 8,000 people died because their illness wasn't spotted quickly enough. Even if patients don't die, they might need longer in hospital and more care. This costs the NHS a lot more money. It also means fewer beds for other patients. Finding better ways to spot these problems early is an important goal. The Opportunity - Research shows checking patients more often helps spot problems early. Nurses do many routine checks. These include blood pressure, temperature, heart rate and oxygen levels. Nurses also check the breathing rate (the number of breaths per minute). Breathing rate is the best way to tell if someone is getting sicker. But it is also the hardest to measure properly. The machines we have don't do it well. So, nurses stand by the patient and count how fast they are breathing. This takes time and can be wrong if the patient talks or moves. Sometimes, it's not done at all. The Need - Breathing rate is very useful. But we don't have good tools to measure it easily. We need something simple and accurate. It should also be comfortable for patients and fit into normal hospital care. Our New Idea - RespiraFibre - We've made a new device called RespiraFibre. It's a tiny, smart sensor. It attaches to the oxygen masks or tubes that patients already wear. It can tell how the patient is breathing. If something is wrong, it sends a warning to the nurse or doctor. In this project, we will: 1. Work with patients to make sure the RespiraFibre is comfortable. 2. Make sure hospital staff find it easy to use. 3. Test how accurate it is. 4. Try it out on real hospital wards. 5. Get it ready to use in hospitals across the country. The Impact - We want to treat patients fast if they get sick. To do this, we need early warnings if things are getting worse. This will lead to better care, fewer deaths, and lower costs for the NHS. Our work with RespiraFibre will help make this happen.

Подробное описание

Clinical study to assess the function of a novel nanotechnology breathing monitor. It will involve a validation study and a feasibility study of the technology.

1. Validation Study - participants who have had surgery and will be admitted to the post-operative recovery department will be invited to take part. These patients receive capnography RR monitoring as standard in a high dependency area and therefore are the ideal group for validation of our technology. We will recruit participants who are undergoing elective surgery therefore will be able to identify them in advance from surgical lists and start the consenting process before admission to hospital. UCLH is a busy surgical centre so recruitment of 48 participants is achievable within 6 months. 2. Feasibility study - we will focus monitoring on select wards to concentrate equipment and test ability to monitor multiple participants in the same area simultaneously. The primary focus will be recruitment of participants who have undergone major surgery (defined as expected length of stay \>2days) who are recovering on the surgical and post-anaesthetic wards. This group have significant risk of deterioration, mostly require oxygen and are a large group at UCLH. We will focus on elective surgery participants again so we are able to start the consenting process prior to admission. A secondary group of patients who require oxygen due to non-surgical illnesses, such as pneumonia, will also be recruited on the medical wards, to test feasibility in another patient group who will potentially benefit in the future.

Вмешательства

• Устройство Nanotechnology respiratory monitor
  Patented wireless nanotechnology breathing monitor integrated into oxygen delivery devices to provide continuous respiratory monitoring.

Первичные конечные точки

• Validation of respiratory rate measurement against capnography [Срок оценки: within 6 months]
• Demonstrate successful function on hospital wards [Срок оценки: within 30 months]

Критерии участия

Критерии включения

• Have capacity to consent to the study
• Undergoing surgery or receiving oxygen therapy

Критерии исключения

• Inability to wear the monitor as designed

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

Великобритания · 1 центр

• University College London Hospital — London

Идентификаторы

NCT: NCT07650539 · 180997

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗