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EARSATS-19: In-ear Measurement of Blood Oxygen Saturation in COVID-19 Follow up

NCT04529408 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2023-10-17

No results posted yet for this study

Summary

TITLE EARSATS-19: In-ear measurement of blood oxygen saturation in COVID-19 follow up

DESIGN Non-inferiority study

AIMS To evaluate qualitative and quantitative performance of in-ear SpO2 monitoring against the gold standard right finger-clip pulse oximeter -- towards validation for use in COVID-19 in the acute ambulatory and long-term monitoring setting

OUTCOME MEASURES

In-ear SpO2 compared with gold-standard finger-clip pulse oximeter:

Correlation between SpO2 measurements at rest Correlation between SpO2 measurements during 6 minute walk test Signal quality during 6 minute walk test Qualitative evaluation of clinical and patient user acceptability using questionnaires

POPULATION 30 patients attending COVID-19 follow-up clinic and 30 patients with chronic lung disease attending routine outpatient investigations

ELIGIBILITY Aged 18 and above, no upper age limit Able to give informed consent No abnormal ear anatomy.

DURATION 12 months

Conditions

  • Covid19
  • Pulmonary Disease

Interventions

DEVICE

EarSats Pulse Oximeter Probe

Off-the-shelf pulse oximeter embedded into a memory foam ear plug for measuring blood oxygen saturation (SpO2) from the ear canal; in-ear SpO2 measured at-rest and during 6 minute walk test

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Nicholas Peters, MD · Imperial College London

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-26
Primary Completion
2022-08-10
Completion
2022-08-10

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04529408 on ClinicalTrials.gov