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
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
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