PneumoRator adhesive chest sensor to monitor breathing after elective surgery
Clinical Validation of the PneumoRator Respiratory Rate Sensor in a Perioperative Cohort
This trial will test a small adhesive chest sensor called the PneumoRator to continuously measure breathing rate in adults having elective surgery who will stay in hospital and go to the Surgical High Dependency Unit.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Southampton NHS Foundation Trust Academic / other |
| Locations | 1 site (Southampton) |
| Trial ID | NCT07293299 on ClinicalTrials.gov |
What this trial studies
Researchers will attach the PneumoRator, a small adhesive device, to patients' chests to record continuous breathing rate around the time of elective surgery. Participants are adults referred for CPET and expected to stay >24 hours postoperatively with planned admission to the Surgical High Dependency Unit and routine invasive arterial monitoring. The observational study will collect PneumoRator data alongside standard vital signs and routine clinical observations to check how reliably the device measures breathing during movement and clinical care. The goal is to describe device performance, comfort, and feasibility for continuous respiratory monitoring in the perioperative setting.
Who should consider this trial
Good fit: Adults (18+) referred for CPET and scheduled for elective surgery with an expected >24 hour hospital stay, planned SHDU admission, routine invasive arterial monitoring, capacity to consent, intact skin at the attachment site, and no allergy to adhesives or implantable electronic devices.
Not a fit: Children, people under 18, those with implantable electronic devices, adhesive allergies, fragile or broken skin at the attachment site, or those not having SHDU care or invasive arterial monitoring are not eligible and are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the device could provide comfortable, continuous and accurate breathing-rate monitoring that helps detect deterioration earlier and reduce staff time spent on manual counts.
How similar studies have performed: Wearable respiratory sensors have shown promise in some studies but often struggle with comfort and motion artefact, so the PneumoRator approach is a relatively novel, early-stage device being tested in routine clinical conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Have undergone or are referred for CPET 2. are scheduled for elective surgery and expected to have \>24 hours postoperative hospital stay 3. Will be admitted to the Surgical High Dependancy Unit (SHDU) as part of their planned care 4. will receive invasive arterial pressure monitoring as part of routine care 5. are aged 18 or over 6. have the capacity to give consent to participate Exclusion Criteria: 1. do not proceed to surgery following CPET referral 2. are aged less than 18 years 3. do not have capacity to consent 4. decline to consent 5. have sensitivity or allergy to medical adhesives 6. 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. 7. patients with implantable electronic medical devices (e.g. pacemakers, nerve stimulators)
Where this trial is running
Southampton
- University Hospital Southampon NHS Foundation Trust — Southampton, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.