3% oxygen desaturation indices (ODI) in healthy children-normal values
Research type
Research Study
Full title
A study to assess the normal overnight 3% desaturation index (DI) in healthy children under 12 years using Masimo technology
IRAS ID
171144
Contact name
Hazel Evans
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
2 years, 4 months, 1 days
Research summary
Pulse oximetry is commonly used to detect changes in blood oxygen levels and detect interruptions in breathing. An important index of falls in oxygen level widely reported is the 4% desaturation Index (DI). This is a drop in oxygen saturations of 4% from baseline as measured by a sensitive modern pulse oximeter able to exclude movement. In 2012 The American Academy of Sleep Medicine (AASM) updated their paediatric guidelines to recommend adopting >3% DI when analysing sleep studies. However there is very little data on normal 3% DI in children, thus it’s significance is unclear. It is therefore essential to obtain reference values, which at present are not available. This study aims to determine the normal reference ranges for mean 3% DI with 95% confidence intervals on healthy children.
Healthy children of health care professionals (HCP) and children attending clinic will be approached. Information about the study will be available via poster with contact details for HCP or in clinic families will be asked if they are willing to talk to the researcher. If so they will be given more information on the study. Oximetry studies will take place at home after families have consented and been shown how to use the equipment. Parents will complete a sleep log recording information on the child’s sleep onset time, morning wake up time, night wakings, and extent to which the night’s sleep was typical for the child on the night of study. The equipment will be running overnight, with alarms disabled and the monitor round the child’s foot for safety. The monitor will be downloaded the next morning and data will be analysed. After completion of one overnight study the family’s involvement will end. They can withdraw from the study at any time.
REC name
London - Queen Square Research Ethics Committee
REC reference
16/LO/2254
Date of REC Opinion
24 Jan 2017
REC opinion
Further Information Favourable Opinion