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Not yet recruitingNCT07650539ROBUSTUpdated Jun 16, 2026

Respiratory OBservation Using Ultra-Sensitive nanoTechnology

An interventional study of Nanotechnology respiratory monitor in Respiratory Monitoring, sponsored by University College, London. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by University College, London · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
148
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

Read the detailed description

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.
02

Conditions studied

  • Respiratory Monitoring

Keywords

  • Nanotechnology sensor
  • Continuous respiratory monitoring
  • Clinical deterioration detection
  • Validation study
  • Feasibility study
03

In context

Lead sponsor

University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Inability to wear the monitor as designed
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
148 participants (estimated)

Study arms

  • Active comparator
    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.

    Device: Nanotechnology respiratory monitor

  • Active comparator
    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.

    Device: Nanotechnology respiratory monitor

Interventions

  • DeviceNanotechnology respiratory monitor

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

06

What researchers measure

Primary outcomes

  1. Validation of respiratory rate measurement against capnography

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

    Time frame: within 6 months

  2. Demonstrate successful function on hospital wards

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

    Time frame: within 30 months

07

Study locations

1 site
  • University College London Hospital
    London, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07650539
Lead sponsor
University College, London
Responsible party
Sponsor
First posted
Jun 16, 2026
Start date
Aug 2026 (estimated)
Primary completion
Feb 2029 (estimated)
Completion
Feb 2029 (estimated)
Last update
Jun 16, 2026

Study contacts

Robert Tidswell, MBChB PhD
Contact
robert.tidswell@nhs.net
004420 3456 7890
Robert Tidswell, MBChB PhD
principal investigator · University College London Hospitals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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