Smartwatch accuracy for measuring oxygen levels in pulmonary hypertension
Accuracy of Wrist-worn Pulse Oximeter SpO2 Measurements in Patients Diagnosed With Pulmonary Hypertension
This project will test whether smartwatches can accurately measure oxygen levels in adults with pulmonary hypertension at rest, after exercise, and during a low-oxygen challenge.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Golden Jubilee National Hospital Government |
| Locations | 1 site (Glasgow) |
| Trial ID | NCT07311135 on ClinicalTrials.gov |
What this trial studies
This single-visit observational pilot will compare SpO2 values from consumer smartwatches with simultaneous finger pulse oximetry and arterial blood gas measurements in people with pulmonary hypertension. Participants will have an arterial line placed and undergo measurements at rest, after a six-minute walk test, and during a controlled hypoxic challenge to simulate high altitude. Data will be collected at the Golden Jubilee National Hospital in Glasgow to determine how closely smartwatch readings match clinical reference standards. The goal is to characterize accuracy and limitations of smartwatch SpO2 in this specific patient group.
Who should consider this trial
Good fit: Adults (≥18) with pulmonary hypertension confirmed by right heart catheterisation who can perform a six-minute walk test, have resting SpO2 ≥88%, and can give written informed consent are ideal candidates.
Not a fit: People with peripheral arterial disease, dorsal wrist tattoos or skin markings, bleeding disorders or on anticoagulation that precludes arterial line placement, or with resting SpO2 <88% are not eligible and would not benefit from the results of this protocol.
Why it matters
Potential benefit: If successful, reliable smartwatch SpO2 readings could allow easier home monitoring and earlier detection of oxygen problems for people with pulmonary hypertension.
How similar studies have performed: Previous studies of consumer smartwatches for SpO2 have shown mixed accuracy compared with pulse oximeters and arterial blood gases, so applying these devices to pulmonary hypertension is only partially tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18-years old and above. * Diagnosed with pulmonary hypertension by right heart catheterisation showing a baseline mean pulmonary artery pressure \> 20mmHg, PVR \>2 Woods Units. * Able to perform a six-minute walk test (6MWT) * Able to give written informed consent. Exclusion Criteria: * Peripheral arterial disease * Tattoos or skin markings which cover the dorsal wrist. * Resting SpO2 \<88% * Severe concurrent medical condition that would prevent participation in study procedures or with life expectancy \<3 months * Patients with bleeding disorders * Patients on anticoagulation * Except in circumstances where anticoagulation is given solely for historical perceived long term survival benefit for pulmonary arterial hypertension. This patient group could be given the option to come off their anticoagulation for 1 week prior to the study visit if they wished to take part in the study. It could then be restarted the day following the study visit providing there were no bleeding complications related to the arterial line.
Where this trial is running
Glasgow
- Golden Jubilee National Hospital — Glasgow, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Martin Johnson, BA, MBChB(Hons), MD, FRCP — Golden Jubilee National Hospital
- Study coordinator: Martin Johnson, BA, MBChB(Hons), MD, FRCP
- Email: martin.johnson@nhs.scot
- Phone: (0044) 0141 951 5497
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.