Lead investigator
Professor Steve Cunningham
Royal Hospital for Children and Young People, 50 Little France Crescent, Edinburgh, EH164TJ.
About the study
Overview
Near fatal asthma (NFA) is the most severe form of survivable asthma attack. Our aim is to describe the frequency, risks factors, clinical care and future asthma risk of children and young people (aged 5-15 years) experiencing a Delphi defined near fatal asthma attack. A greater understanding of the frequency and risk factors associated with NFA could help support the patient, parents and clinicians to identify and modify risk, both independently and through a resulting clinical care pathway and also develop future research to improve effectiveness of interventions.
We will explore both commonly identified clinical factors, but also for the first time describe in detail the variance in medical management (acute and intensive care) that could lead to future clinical trials and guideline development to standardise care. The study will also describe, through data-linkage, socio-demographic factors associated with NFA, to include pollution, pollen, weather, viral prevalence that could lead to better care for higher risk patients.
To encourage more consistent, less fragmented care following a near fatal asthma attack, the study team will consider how care is provided subsequent to an NFA attack using BPSU surveillance at 12 and 24 month follow up.
Case definition
Cases will be defined as (1) or (2) or (3)
(1)Any child aged 5-15 years surviving* an acute episode of asthma, who when presenting self-ventilating with severe dyspnoea (e.g. inability to speak) and all the following features:
- a)Pulse oxygen saturation below 92% despite maximal oxygen therapy (i.e. 10-15l/min oxygen flow via non-rebreather mask) during acute presentation and
- b) pH <= 7.2 and/or pCO2 >=60mmHg or 8kPa and
- c)Escalation to use of intravenous bronchodilator infusion
(2) Any child aged 5-15 years surviving* an acute episode of asthma, who had a respiratory arrest and/or required cardiopulmonary resuscitation as part of their presentation.
(3) Any child age 5-15 years surviving* an acute episode of asthma for which he/she was invasively ventilated.
*surviving to hospital discharge
Reporting instructions
Please report any case that meets the above definition. Clinicians are encouraged to report the event even if final outcome is not yet known or the patient is still receiving ongoing care in hospital.
Duration
18 months of surveillance from October 2022 with follow up of cases at 12 months and 24 months
Funding
Chief Scientists Office, Scotland (Reference HIPS/20/21)
Approval
This study has gained favourable ethical opinion from the following panels:
South East Scotland Research Ethics Committee (Reference 22/SS/0030)
Confidential Advisory Group (Reference 22/CAG/0055)
Privacy Benefit and Privacy Panel (Reference 2122-0172 Cunningham)
Privacy Notice
NHS Lothian and the University of Edinburgh are joint data controllers for this research study. The study sponsor ACCORD (Ref AC22026) They can be contacted at resgov@accord.scot. The Queens Medical Research Institute, 47 Little France Crescent, EH164TJ. The Data Protection Officer at the University of Edinburgh, Dr Rena Gertz can be contacted at dpo@ed.ac.uk
The study team at University of Edinburgh will use information supplied by clinicians from medical records for this research study. The lawful basis for collecting and using personal information in this study is article 6(1)(e) and article 9(2)(j) of the GDPR which allows us to process personal data when it is for scientific research in the public interest. We will collect information about children and young people diagnosed with Near Fatal Asthma from the clinicians who are looking after them. Clinicians will not provide identifying information like names and addresses, but they will provide personal information like sex, ethnic group, postcode and date of birth. The smallest amount of personal information will be used. We cannot withdraw or remove information from the study but personal information will be deleted or de-personalised when the study finishes. The information will be securely stored in a safe haven (https://www.dundee.ac.uk/hic) for 20 years.
If you want access to the information in your child’s NHS records, then you should contact your child’s NHS hospital/doctor.
If you want to find out more about how personal information is used in the study, please contact steve.cunningham@ed.ac.uk
If you wish to complain about the use of your personal information, then you should contact the Information Commissioner’s Office (UK):
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire SK9 5AF
Helpline number: 0303 123 1113
Email: casework@ico.org.uk
Republic of Ireland https://www.oic.ie/about/who-we-are/
Support group
Asthma UK Centre for Applied Research
Asthma UK
British Lung Foundation