Smartwatch accuracy for measuring oxygen levels in pulmonary hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.