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EARSATS-19 V1.0 [COVID-19]

  • Research type

    Research Study

  • Full title

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

  • IRAS ID

    285603

  • Contact name

    Nicholas Peters

  • Contact email

    n.peters@imperial.ac.uk

  • Sponsor organisation

    Imperial College London

  • Clinicaltrials.gov Identifier

    NA, NA

  • Duration of Study in the UK

    1 years, 0 months, 1 days

  • Research summary

    \nTITLE\nEARSATS-19: In-ear measurement of blood oxygen saturation in COVID-19 follow up\n\n\nDESIGN\nNon-inferiority study (to show new technology is as good or possibly better than what we currently use)\n\nAIMS\nTo evaluate qualitative and quantitative performance of in-ear pulse oximetry (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 \n\nOUTCOME MEASURES\nIn-ear SpO2 compared with gold-standard finger-clip pulse oximeter:\n- Correlation between SpO2 measurements at rest \n- Correlation between SpO2 measurements during 6 minute walk test\n- Signal quality during 6 minute walk test\n- Qualitative evaluation of clinical and patient user acceptability using questionnaires\n\nPOPULATION\n30 patients attending COVID-19 follow-up clinic and 30 patients with chronic lung disease attending routine outpatient investigations (baseline SpO2 measurement and 6 minute walk test)\n\nELIGIBILITY\nAged > 18, no upper age limit\nAble to give informed consent\nNo abnormal ear anatomy.\n\nDURATION\n6 months initial phase\n

  • REC name

    South Central - Oxford A Research Ethics Committee

  • REC reference

    20/SC/0315

  • Date of REC Opinion

    19 Aug 2020

  • REC opinion

    Further Information Favourable Opinion