PROXY N
Research type
Research Study
Full title
PRecision and accuracy of pulse OXimetrY in cyanotic childreN
IRAS ID
206592
Contact name
Balazs K Fule
Contact email
Sponsor organisation
Birmingham Children's Hospital
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
Oxygen saturation monitoring is a crucial part of paediatric health care. Studies have demonstrated inaccuracy of pulse oxymetry (SpO2) in children with low oxygen levels (hypoxic). Nonin 6000CI have not previously been tested in hypoxic children. The study aims to assess the accuracy of these sensors in this patient population.
We will be assessing the accuracy by way of comparison to arterial blood gas co-oximetry (SaO2).
Data collection will require simultaneous monitoring of SpO2 with Nonin 6000CI and standard use sensors (Masimo LNCS) providing comparison of SpO2 data to SaO2 results measured by co-oximetry (blood gas).
We aim to recruit 40 patients on the paediatric intensive care unit to obtain 72 hours of monitoring or 8 sets of comparative data (Sp02 to SaO2).
Eligibility criteria will be inpatients on PICU who have arterial line monitoring in situ. We will include children with standard oxygen saturation levels as well as hypoxic children.We expect the study to reach completion within 12 months from the start of enrolment. The participants will wear one additional saturation probe (a small plaster like sensor, typically on the finger or toe). Arterial blood samples will be taken according to clinical needs to provide comparative SaO2 data (no extra blood samples will be taken for research purposes.)
Data analysis will involve calculation of accuracy (ARMS), bias and precision (Bland-Altman) throughout the whole SaO2 range and in predefined ranges (70-100, 70-80, 80-90, 90-100).REC name
West Midlands - Solihull Research Ethics Committee
REC reference
17/WM/0133
Date of REC Opinion
16 May 2017
REC opinion
Further Information Favourable Opinion