Respiratory OBservation Using Ultra-Sensitive nanoTechnology

NCT07650539 | Not Yet Recruiting DMC

• 1 other identifier: 180997
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Work with patients to make sure the RespiraFibre is comfortable.
2. 2.Make sure hospital staff find it easy to use.
3. 3.Test how accurate it is.
4. 4.Try it out on real hospital wards.
5. 5.Get it ready to use in hospitals across the country.

Conditions

Respiratory Monitoring

Keywords

Nanotechnology sensor; Continuous respiratory monitoring; Clinical deterioration detection; Validation study; Feasibility study

Outcome Measures

Primary Outcomes (2)

• Validation of respiratory rate measurement against capnography

  Comparison of respiratory rate captured by experiemental device against that captured by capnography

  within 6 months

• Demonstrate successful function on hospital wards

  Demonstration of continuous respiratory rate monitoring in patients on hospital wards with comparison to usual care

  within 30 months

Study Arms (2)

Validation arm - comparison to capnography

ACTIVE COMPARATOR

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.

Device: Nanotechnology respiratory monitor

Feasibility study

ACTIVE COMPARATOR

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.

Device: Nanotechnology respiratory monitor

Interventions

Nanotechnology respiratory monitor DEVICE

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

Feasibility study; Validation arm - comparison to capnography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Inability to wear the monitor as designed

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospital

London, United Kingdom

Location

Study Officials

• Robert Tidswell, MBChB PhD

  University College London Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Tidswell, MBChB PhD

CONTACT

004420 3456 7890; robert.tidswell@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)