Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Respiratory OBservation Using Ultra-Sensitive nanoTechnology (ROBUST)

10 juin 2026 mis à jour par: University College, London

Respiratory Observation Using Ultra-Sensitive Nanotechnology

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

148

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

      • London, Royaume-Uni
        • University College London Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

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

Exclusion Criteria:

  • Inability to wear the monitor as designed

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Faisabilité de l'appareil
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Validation arm - comparison to capnography
Our monitor will be compared to the gold standard for respiratory rate monitoring, capnography. It will also be compared to direct expert manual respiratory rate assessment performed by the research team for added validation and to recognise that capnography is not infallible.
Patented wireless nanotechnology breathing monitor integrated into oxygen delivery devices to provide continuous respiratory monitoring.
Comparateur actif: Feasibility study
We will observe use of our monitor in its planned ultimate environment - hospital wards. We will assess function and monitoring capability and compare it to standard of care.
Patented wireless nanotechnology breathing monitor integrated into oxygen delivery devices to provide continuous respiratory monitoring.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Validation of respiratory rate measurement against capnography
Délai: within 6 months
Comparison of respiratory rate captured by experiemental device against that captured by capnography
within 6 months
Demonstrate successful function on hospital wards
Délai: within 30 months
Demonstration of continuous respiratory rate monitoring in patients on hospital wards with comparison to usual care
within 30 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Robert Tidswell, MBChB PhD, University College London Hospitals

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

1 février 2029

Achèvement de l'étude (Estimé)

1 février 2029

Dates d'inscription aux études

Première soumission

10 juin 2026

Première soumission répondant aux critères de contrôle qualité

10 juin 2026

Première publication (Réel)

16 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner