Respiratory MonitoringROBUSTNCT07650539
Respiratory OBservation Using Ultra-Sensitive nanoTechnology
A study testing Nanotechnology respiratory monitor in people with Respiratory Monitoring, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Monitoring
- What is being tested?
- Nanotechnology respiratory monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2026to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have capacity to consent to the study
- Undergoing surgery or receiving oxygen therapy
Who cannot join
- Inability to wear the monitor as designed
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
University College London Hospital
London
Robert Tidswell, MBChB PhD, 004420 3456 7890, robert.tidswell@nhs.net
About this study
Official title: 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.
Read more
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:
- Work with patients to make sure the RespiraFibre is comfortable.
- Make sure hospital staff find it easy to use.
- Test how accurate it is.
- Try it out on real hospital wards.
- 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.
- 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.
- 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.
- Conditions
- Respiratory Monitoring
- Being tested
- Nanotechnology respiratory monitor
- Keywords
- Nanotechnology sensor, Continuous respiratory monitoring, Clinical deterioration detection, Validation study, Feasibility study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanotechnology respiratory monitorDevice
Patented wireless nanotechnology breathing monitor integrated into oxygen delivery devices to provide continuous respiratory monitoring.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Nanotechnology respiratory monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of respiratory rate measurement against capnography
Comparison of respiratory rate captured by experiemental device against that captured by capnography
Measured: 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
Measured: within 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory MonitoringStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Tidswell, MBChB PhD, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650539
- Sponsor's protocol ID
- 180997
- Acronym
- ROBUST
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Observation Using Ultra-Sensitive Nanotechnology
- ClinicalTrials.gov ID
- NCT07650539
- Acronym / sponsor ID
- ROBUST / 180997
- Conditions
- Respiratory Monitoring
- Keywords
- Nanotechnology sensor, Continuous respiratory monitoring, Clinical deterioration detection, Validation study, Feasibility study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Work with patients to make sure the RespiraFibre is comfortable.
- Make sure hospital staff find it easy to use.
- Test how accurate it is.
- Try it out on real hospital wards.
- 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.
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.
- 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.
- 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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Validation arm - comparison to capnography | Active comparator | Device: Nanotechnology respiratory monitorOur 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. |
| Feasibility study | Active comparator | Device: Nanotechnology respiratory monitorWe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have capacity to consent to the study
- Undergoing surgery or receiving oxygen therapy
Key exclusion criteria (1 listed)
- Inability to wear the monitor as designed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanotechnology respiratory monitorPatented wireless nanotechnology breathing monitor integrated into oxygen delivery devices to provide continuous respiratory monitoring. | Device | Feasibility study, Validation arm - comparison to capnography |
Primary outcome
Validation of respiratory rate measurement against capnography
Time frame: within 6 months
Comparison of respiratory rate captured by experiemental device against that captured by capnography
Demonstrate successful function on hospital wards
Time frame: within 30 months
Demonstration of continuous respiratory rate monitoring in patients on hospital wards with comparison to usual care
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Tidswell, MBChB PhD principal investigator
University College London Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nanotechnology respiratory monitor in people with Respiratory Monitoring, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Tidswell, MBChB PhD (004420 3456 7890, robert.tidswell@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of respiratory rate measurement against capnography (time frame: within 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.