Accuracy of Smartwatches in Measuring Oxygen Levels in Patients With Pulmonary Hypertension: A Pilot Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGolden Jubilee National Hospital

About this trial

The goal of this study is to learn how accurate smartwatches are at measuring oxygen levels in patients with a condition called pulmonary hypertension. The main questions it aims to answer are:

* How accurate the smartwatches are at measuring oxygen levels when the patient is sitting at rest * How accurate are smartwatches at measuring oxygen levels after exercise * How accurate are smartwatches at measuring oxygen levels after breathing a lower level of oxygen through a mask.

Researchers will compare oxygen levels measured through a smartwatch with those checked through a finger probe oxygen monitor and also from a blood sample checked from the artery in the wrist to see if smartwatch oxygen measurements are similar.

Participants will:

-Attend the hospital once, just for a few hours to collect all the required data.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Patients attending outpatient clinic at the Golden Jubilee National Hospital under the care of the Scottish Pulmonary Vascular Unit.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

20 Participants
are grouped into 1 trial group
Group A: Adult patients with pulmonary hypertension

Trial outcomes

Primary outcomes

1

Agreement of oxygen saturations (SpO2) measured by the wrist-worn pulse oximeter when compared with arterial blood gas oxygen saturations (SaO2) at rest

SpO2 (measured by the wrist-worn pulse oximeter (smartwatch) and standard fingerprobe pulse oximeter) and SaO2 (measured by the arterial blood gas analysis) measured as a percentage.

Time frame
1 study visit, anticipated to be around 3 hours.

Secondary outcomes

1

1. Agreement of oxygen saturations (SpO2) measured by the wrist-worn pulse oximeter when compared with arterial blood gas oxygen saturations (SaO2) after exercise

SpO2 (measured by the wrist-worn pulse oximeter (smartwatch) and standard fingerprobe pulse oximeter) and SaO2 (measured by arterial blood gas analysis) measured as a percentage after exercise

Time frame
1 study visit, estimated 3 hours duration
2

1. Agreement of oxygen saturations (SpO2) measured by the wrist-worn pulse oximeter when compared with arterial blood gas oxygen saturations (SaO2) after a hypoxic challenge

SpO2 (measured by the wrist-worn pulse oximeter (smartwatch) and standard fingerprobe pulse oximeter) and SaO2 (measured by arterial blood gas analysis) measured as a percentage, after a hypoxic challenge test.

Time frame
1 study visit, estimated 3 hours duration

Other outcomes

Sponsors and contacts

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