RespiratoryNCT07293299
The PneumoRator Study
An observational study of Respiratory and Monitored Anaesthesia Care, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Healthcare workers measure heart rate, blood pressure, temperature, oxygen levels and breathing rate to monitor how unwell a patient is. All these apart from breathing rate are now normally measured by machines. But there still isn't a machine that does this well enough for breathing rate to be used in most places. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory, Monitored Anaesthesia Care, Perioperative
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Apr 2025to 24 Apr 2026
- Phase
- Observational
- 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
Study population: The study comprises patients undergoing intermediate-high risk major surgery at University Hospital Southampton who are planned for admission to the Surgical High dependency unit (SHDU)
Who may be able to join
- Have undergone or are referred for CPET
- are scheduled for elective surgery and expected to have >24 hours postoperative hospital stay
- Will be admitted to the Surgical High Dependancy Unit (SHDU) as part of their planned care
- will receive invasive arterial pressure monitoring as part of routine care
- are aged 18 or over
- have the capacity to give consent to participate
Who cannot join
- do not proceed to surgery following CPET referral
- are aged less than 18 years
- do not have capacity to consent
- decline to consent
- have sensitivity or allergy to medical adhesives
- patients with fragile, erythematous, or broken skin at the site of PnemoRator attachment or any other condition which, in the view of the clinical research team, may mean that the use of the PnemoRator device and adhesive is likely to cause patient harm.
- patients with implantable electronic medical devices (e.g. pacemakers, nerve stimulators)
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, 1 recruiting
- Recruiting
University Hospital Southampon NHS Foundation Trust
Southampton
Critical Care Research Team, +4423 8120 5308, CriticalCareResearch@uhs.nhs.uk
About this study
Official title: Clinical Validation of the PneumoRator Respiratory Rate Sensor in a Perioperative Cohort
Healthcare workers measure heart rate, blood pressure, temperature, oxygen levels and breathing rate to monitor how unwell a patient is. All these apart from breathing rate are now normally measured by machines. But there still isn't a machine that does this well enough for breathing rate to be used in most places. The machines that do exist are either uncomfortable or don't work well on patients who are moving. Instead, a healthcare worker will count the number of breaths a patient takes. This needs staff time and isn't very accurate.
It is known that changes in breathing rate can happen any time. But healthcare systems normally only measure it every few hours because it takes time. Breathing rate could be monitored all the time, we might pick up people getting sick earlier and be able to treat them more quickly, which could save lives.
Read more
A team at the University of Southampton has made a small device, called a PneumoRator, that gets stuck to onto a person's chest. Once stuck there it can measure their breathing rate and store or send that information wirelessly. The device has been tested on healthy volunteers but has never been tested on patients in hospital.
In this study the team will put the device on patients having major operations. The investigators will record information already collected about patients during normal care. This includes their breathing rate using the best measurement we have, where a patient's breathing is measured by a gas they breathe out. The gas is carbon dioxide, and the measurement is called capnography. This way of measuring is only used in operating theatres and intensive care units but is a good way to check if the PneumoRator is accurate.
The investigators want to attach the PneumoRator to patient's chests before they go to sleep for their operation and leave it there for the first few days after their operation. This will let them see how the PneumoRator compares to capnography and manual breath counting. It will also let them see how the device works at different times in the patient's journey. The investigators will look at the time when patients are asleep, when breathing is controlled by a machine. Then when patients wake up investigators can measure with both capnography and the PneumoRator. Finally, when patients go to the high dependency ward, investigators will compare it against manual counting. The study team will also ask patients how they found wearing the device and any problems they found.
With this information the investigators hope to show the PenumoRator is accurate at measuring breathing rate and comfortable for patients. This will help them get the device approved for use in hospitals and other places where breathing rate needs to be measured accurately.
- Conditions
- Respiratory, Monitored Anaesthesia Care, Perioperative
- Keywords
- monitoring, respiratory rate, sensor, wearable
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between respiratory rate measured by the PneumoRator device and waveform capnography
Measured: From start of anaestheisa care until departure from PACU (Recovery)
Secondary outcomes (3)
Agreement between respiratory rate measured by the PneumoRator device and manual breath counting
Measured: Post-operative Day 1
Agreemement between PneumoRator and ECG based measurement of respiratory rate
Measured: Perioperatively
Patient comfort while wearing the PneumoRator
Measured using likert-scale, created specifically for this study. Higher score means more discomfort. Minimum score = 3, maximum score = 15. Questions below, (choices in brackets each rated from 1-5):
- How much discomfort, specifically related to the PneumoRator device, did you experience? (No discomfort, Mild discomfort, Moderate discomfort, Severe discomfort, Unbearable discomfort)
- How frequently did you experience discomfort, specifically related to the PneumoRator device? (Never, Rarely, Sometimes, Often, Constant)
- Having worn the PneumoRator device how concerned would you be about wearing the device in future? (Not concerned at all, Unconcerned, Neutral, Concerned, Very Concerned)
Measured: Postoperative day 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start25 Apr 2025
- Primary completion24 Apr 2026 (estimated)
- Study completion24 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RespiratoryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southampton, NIHR Southampton Respiratory Biomedical Research Centre, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293299
- Sponsor's protocol ID
- RHM CRI0439
- Other IDs
- NIHR202107
- Status last verified
- Oct 2025
- First submitted
- 24 Nov 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the PneumoRator Respiratory Rate Sensor in a Perioperative Cohort
- ClinicalTrials.gov ID
- NCT07293299
- Acronym / sponsor ID
- RHM CRI0439
- Conditions
- Respiratory, Monitored Anaesthesia Care, Perioperative
- Keywords
- monitoring, respiratory rate, sensor, wearable
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Southampton, NIHR Southampton Respiratory Biomedical Research Centre, National Institute for Health Research, United Kingdom
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- 24 Apr 2026 (estimated)
- Study completion
- 24 Apr 2026 (estimated)
- First posted
- 19 Dec 2025 (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.
Healthcare workers measure heart rate, blood pressure, temperature, oxygen levels and breathing rate to monitor how unwell a patient is. All these apart from breathing rate are now normally measured by machines. But there still isn't a machine that does this well enough for breathing rate to be used in most places. The machines that do exist are either uncomfortable or don't work well on patients who are moving. Instead, a healthcare worker will count the number of breaths a patient takes. This needs staff time and isn't very accurate.
It is known that changes in breathing rate can happen any time. But healthcare systems normally only measure it every few hours because it takes time. Breathing rate could be monitored all the time, we might pick up people getting sick earlier and be able to treat them more quickly, which could save lives.
A team at the University of Southampton has made a small device, called a PneumoRator, that gets stuck to onto a person's chest. Once stuck there it can measure their breathing rate and store or send that information wirelessly. The device has been tested on healthy volunteers but has never been tested on patients in hospital.
In this study the team will put the device on patients having major operations. The investigators will record information already collected about patients during normal care. This includes their breathing rate using the best measurement we have, where a patient's breathing is measured by a gas they breathe out. The gas is carbon dioxide, and the measurement is called capnography. This way of measuring is only used in operating theatres and intensive care units but is a good way to check if the PneumoRator is accurate.
The investigators want to attach the PneumoRator to patient's chests before they go to sleep for their operation and leave it there for the first few days after their operation. This will let them see how the PneumoRator compares to capnography and manual breath counting. It will also let them see how the device works at different times in the patient's journey. The investigators will look at the time when patients are asleep, when breathing is controlled by a machine. Then when patients wake up investigators can measure with both capnography and the PneumoRator. Finally, when patients go to the high dependency ward, investigators will compare it against manual counting. The study team will also ask patients how they found wearing the device and any problems they found.
With this information the investigators hope to show the PenumoRator is accurate at measuring breathing rate and comfortable for patients. This will help them get the device approved for use in hospitals and other places where breathing rate needs to be measured accurately.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study comprises patients undergoing intermediate-high risk major surgery at University Hospital Southampton who are planned for admission to the Surgical High dependency unit (SHDU)
Key inclusion criteria (6 listed)
- Have undergone or are referred for CPET
- are scheduled for elective surgery and expected to have >24 hours postoperative hospital stay
- Will be admitted to the Surgical High Dependancy Unit (SHDU) as part of their planned care
- will receive invasive arterial pressure monitoring as part of routine care
- are aged 18 or over
Key exclusion criteria (7 listed)
- do not proceed to surgery following CPET referral
- are aged less than 18 years
- do not have capacity to consent
- decline to consent
- have sensitivity or allergy to medical adhesives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement between respiratory rate measured by the PneumoRator device and waveform capnography
Time frame: From start of anaestheisa care until departure from PACU (Recovery)
3 secondary outcomes
Agreement between respiratory rate measured by the PneumoRator device and manual breath counting
Time frame: Post-operative Day 1
Agreemement between PneumoRator and ECG based measurement of respiratory rate
Time frame: Perioperatively
Patient comfort while wearing the PneumoRator
Time frame: Postoperative day 1-3
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 19 Dec 2025.
- 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.
University Hospital Southampon NHS Foundation Trust
Southampton, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory and Monitored Anaesthesia Care, run by University Hospital Southampton NHS Foundation Trust 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 19 Dec 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between respiratory rate measured by the PneumoRator device and waveform capnography (time frame: From start of anaestheisa care until departure from PACU (Recovery)). 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 19 Dec 2025.