For patients

EXAKT is a national research study which aims to better understand the accuracy of pulse oximeters (devices that measure the amount of oxygen in the blood) across different skin tones.

An increasing number of studies have shown that for people with darker (pigmented) skin, pulse oximeters may over-estimate their true oxygen level. This is because the pulse oximeter shines light through the fingertip and skin tone may affect the device’s accuracy. Over-estimation of oxygen levels could under-estimate the seriousness of a person’s illness, leading to them not receiving the correct treatment and come to unnecessary harm. This study aims to find out whether skin tone affects the accuracy of pulse oximeters and confirm whether they over-estimate the level of oxygen in people with darker skin.

This study is sponsored by The Intensive Care National Audit & Research Centre (ICNARC), based in the UK, and they are the people who control the data that is collected and used for the study. This study (EXAKT) is funded by the National Institute for Health and Care Research (NIHR) – Health Technology Assessment Programme.  The NIHR is an organisation that gives government funding for health and health related technology projects. To find out more about the NIHR, please visit their website.

To help us manage and meet the objectives of the study – ICNARC collects and holds personal data about you (and other participants). This information (such as your date of birth, NHS number and health data) was collected by the research/audit team at the hospital where you became involved in the study. This information was securely submitted to ICNARC.

Your private information is important to us, and we want to protect it from being seen by anyone who isn’t connected with the study. One of the ways we do this is by allocating each participant a unique code number, called a ‘trial number’. This means we can hold your data without your personal information being seen by anyone outside the team. The term used for this process is ‘pseudonymised’.

ICNARC will use your data for the purposes of the research. Your date of birth and NHS number will be used to find out more information about you which is relevant to the research, such as your ethnicity. Once the study is finished, statisticians from ICNARC will analyse the information to find out which treatment was most effective.

All of the information is held in a secure password protected database, with access only by authorised research team members at your hospital and at ICNARC. Information collected during EXAKT is stored on ICNARC’s secure servers which are owned by an authorised contractor called Exponential-e. ICNARC takes steps to ensure this information is not lost and makes regular back-ups of the data.

At the end of the study, ICNARC will keep identifiable information (personal data) about you for no longer than one year after the study has finished. The information will be then anonymised so that you can no longer be identified (unless you have agreed otherwise). It will not be possible to identify any person who has taken part in the study in any reports or articles.

ICNARC process data for this study under the legitimate interest legal basis. This is because ICNARC is a registered charity and the data processing described here is to support scientific and statistical research. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible. There is no automated decision making or profiling.

As you were very unwell at the time, a relative, close friend or an independent consultee may have provided their opinion of your wishes, on your behalf. In either situation, you can opt out if you no longer wish that we process your data in these ways (contact details below).

More information about EXAKT is available on this website. If you have any other questions or wish to opt out or withdraw, please contact:

Tasnin Shahid       Trial Manager                                    Tasnin.Shahid@icnarc.org                  020 7269 9277
Paul Mouncey       Joint-Chief Investigator                  Paul.Mouncey@icnarc.org                  020 7269 9277

If you have a complaint about our use of your information, you can contact the Information Commissioner’s Office via their website or write to them at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF