Carbon monoxide screening in ED patients with headache
| ISRCTN | ISRCTN54381468 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54381468 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 335774 |
| Protocol serial number | CPMS 59081 |
| Sponsor | St George’s University Hospitals NHS Foundation Trust |
| Funder | CO Research Trust |
- Submission date
- 23/09/2025
- Registration date
- 08/12/2025
- Last edited
- 08/12/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Carbon monoxide (CO) exposure is an important but often overlooked cause of headaches. Many patients who come to the emergency room with headaches are not routinely checked for CO exposure, and how common it is or which patients are most at risk is not fully understood. Being better at recognising headaches caused by CO could help doctors diagnose the problem earlier, stop people from being exposed to more CO, and prevent long-term brain and health issues. Low-level CO exposure often goes unnoticed, especially indoors, where appliances like boilers or fireplaces may not be working properly or may lack good ventilation. People exposed to these low levels of CO repeatedly often have headaches that do not have an obvious cause, but improve once they are away from the source of CO.
To find out how often CO exposure causes headaches, two main methods have been used: testing CO levels in the blood and checking for sources of CO in a person’s environment. During this study, CO levels will be measured in patients coming to the emergency room with headaches using two methods: a quick, non-invasive finger sensor called CO-oximetry, and a standard blood test. The finger sensor gives fast results without needing a blood sample, and research suggests it can be useful in emergency settings. It might also be cheaper and easier to use, especially in places where blood tests aren’t always possible. Since CO leaves the blood quickly, this quick test could be more effective at catching recent exposure. The study will also collect information about the patients’ environments to see if they are exposed to CO at home. Previous research found that many people do not have CO alarms or are not aware that they do, which puts them at risk of undetected CO exposure. To help track this, a portable CO monitor will be given to each patient to take home for one week. These monitors detect much lower levels of CO than regular alarms.
This study aims to evaluate the feasibility, acceptability, and operational practicality of the one-week home CO monitoring in identifying environmental CO exposure. It will also explore the number of patients attending the Emergency Department (ED) with a simple headache who have been exposed to carbon monoxide, as well as assessing the agreement between different CO measurement methods (blood tests, CO-oximetry, and home monitoring) and how they relate to patient symptoms. The team will also assess the impact of the time of year on CO exposure in homes, and recruitment, retention, data completeness, and participant adherence information will also be analysed. This will lead to the development of draft clinical guidance for identifying and managing CO exposure in patients with headache, suitable for future testing in further research.
Who can participate?
Adult patients aged 18 and over attending the ED with a headache, but are unlikely to be admitted to the hospital.
What does the study involve?
The study is made up of various data collection points outlined below:
During ED visit - Baseline (Day 0):
Whilst in ED, patients will receive two procedures to measure the carbon monoxide levels in their blood (known as carboxyhaemoglobin, or COHb). The first procedure is a routine test that would take place within usual care, which involves a member of the clinical team taking a blood sample and processing it using a device known as a blood gas machine. The second procedure involves a painless finger probe test, where a device will be placed on the tip of a finger to measure COHb levels. Before the participant is discharged from ED, a member of the research team will provide them with a transportable carbon monoxide alarm and instructions on how to use it. All participants will receive a stamped, addressed envelope to return the monitor to the research team after 7 days.
7-day home monitoring phase, post-discharge:
After discharge, the 7-day home monitoring period will begin. Participants will be asked to put the carbon monoxide alarm in their kitchen, as far as possible from the boiler/stove. Participants will receive a daily message or email from the research team each evening with a link to the daily home monitoring questionnaire measuring symptoms, alongside a paper copy.
Day 8:
Participants will be asked to return the monitor to the research team using the stamped, addressed envelope provided. Participants will be given an optional £10 bank transfer upon the return of the monitor.
Day 14 follow-up (± 7 days):
The research team will follow up at 14 days post-discharge to recheck symptoms. If the CO monitor has been received, participants will get the results of the 7-day home monitoring period, and if high levels of CO are detected, they will receive information on corrective measures and may be referred to the National Emergency Gas Service.
[OPTIONAL] CO monitoring follow-up:
For patients who return their CO monitor later than day 14, participants will receive a follow-up telephone call after the symptom check to provide results.
Day 42 follow-up (± 7 days):
All participants will receive a final follow-up at 6 weeks (± 7 days) to recheck symptoms. If the research team detects abnormal levels of CO during the analysis, they will take note of any corrective measures made by participants.
What are the possible benefits and risks of taking part in this study?
The information obtained from this study will help the research team to understand if the study method is feasible among patients with headaches in the ED. This will then inform a larger main trial across multiple centres.
The study will be beneficial to people who have high environmental CO levels recorded, as it will highlight the potential cause of headaches and enable participants to take corrective actions.
There are no anticipated risks or disadvantages to taking part in this study.
Where is the study run from?
St George’s Emergency Department Collaborative Research Group, St George's University Hospitals NHS Foundation Trust, UK
When is the study starting and how long is it expected to run for?
September 2025 to June 2027
Who is funding the study?
The CO Research Trust (CORT), UK
Who is the main contact?
Kathryn Willis (study co-ordinator), EDCOstudy@stgeorges.nhs.uk
Contact information
Public
ED Collaborative Research Group
Emergency Department
St George's University Hospitals NHS Foundation Trust
Blackshaw Road
London
SW17 0RE
United Kingdom
| Phone | +44 (0)20 8266 6928 |
|---|---|
| kathryn.willis@stgeorges.nhs.uk |
Public, Scientific
Population Health Research Institute
City St. George’s, University of London
London
SW17 0WT
United Kingdom
| atkinson@sgul.ac.uk |
Public, Scientific
Population Health Research Institute
City St. George’s, University of London
London
SW17 0QT
United Kingdom
| Phone | +44 (0)7717210601 |
|---|---|
| siclark@sgul.ac.uk |
Public, Scientific
University of Surrey
Guildford
Surrey
GU2 7XH
United Kingdom
| Phone | +44 (0)1483 689215 |
|---|---|
| s.price@surrey.ac.uk |
Public, Scientific, Principal investigator
ED Collaborative Research Group
Emergency Department
St George's University Hospitals NHS Foundation Trust
Blackshaw Road
London
SW17 0RE
United Kingdom
| Phone | +44 (0)20 8266 6928 |
|---|---|
| heather.jarman@stgeorges.nhs.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre longitudinal observational and feasibility study |
| Secondary study design | Longitudinal study |
| Study type | Participant information sheet |
| Scientific title | Screening for low-level carbon monoxide exposure in patients attending the Emergency Department with headache |
| Study acronym | EDCO-H |
| Study objectives | Primary objectives: To evaluate the feasibility, acceptability, and operational practicality of one-week home CO monitoring in identifying environmental CO exposure Secondary objectives: To determine the proportion of patients presenting to Emergency Departments with simple headache who have been exposed to carbon monoxide. To assess the agreement between CO levels measured through blood tests, CO-oximetry, and home monitoring, and their correlation with screening questionnaire responses and patient-reported symptoms To characterise levels and temporal variations in CO exposure in homes To assess recruitment, retention, data completeness, and participant adherence to study procedures To develop draft clinical guidance for identifying and managing CO exposure in patients with headache, suitable for future testing in primary care, EDs, and headache clinics |
| Ethics approval(s) | Pending submission |
| Health condition(s) or problem(s) studied | Carbon monoxide screening in ED patients with headache |
| Intervention | The data collected in this study will be pseudoanonymised and all participants will be assigned a unique identification (ID) number. The clinical research team at the hospital will have access to a data key that links the unique ID number to the participant's medical record number. This will be accessed only by the clinical research team and held on password-protected servers at the local site. 1. Screening assessment All patients attending the Emergency Department will undergo routine clinical assessment, including clinical judgment, blood test measurement and further investigations as per standard practice at the hospital. This information will be used to determine if patients meet the study eligibility criteria. 2. Baseline COHb assessment Eligible participants will be consented before study procedures. All patients considered eligible for the study will have blood drawn as part of routine care in the Emergency Department. This test, known as a venous blood gas, includes COHb measurement and as such, this test is not considered a study procedure. The routinely collected results will be recorded. As near simultaneously as taking the blood sample, the participant will have their CO-oximetry level recorded. This is a device that uses a finger-probe to non-invasively measure CO in the bloodstream. It is not routinely used in ED care but might provide an alternative to blood testing of COHb where this is not available. 3. Data collection – ED attendance Following CO measurements and at an appropriate time whilst in the ED, participants will be guided by research staff through an electronic questionnaire to capture information including demographic characteristics (age, socioeconomic status, ethnicity), smoking status, headache and associated symptoms, and ED attendance information. Participants will be asked specific CO screening questions in line with UK guidance: C – Cohabitees/companions – Is anyone else in the property affected (including pets)? O – Outdoors – Do your symptoms improve when out of the building? (‘better outdoors’) M – Maintenance – Are your fuel-burning appliances and vents properly maintained? A – Alarm – Do you have a carbon monoxide alarm? Additional information on the patient disposition from the ED and their diagnosis will be recorded by the clinical research team from the electronic medical record (EMR). 4. Environmental CO monitoring A key feature of this study is the linking of environmental CO data with the participant’s clinical information. To achieve this, participants will be given a portable ambient CO monitor at hospital discharge for 1 week. Participants will be given instructions on the placement of this in their home. All participants will be given the study coordinator's contact details in case of any questions during the data collection period. Participants will also be provided with a stamped, addressed envelope to return the CO monitor to the research team following data collection. Feasibility will be assessed through monitor return rates, diary completion rates, and participant-reported usability and burden. A study coordinator will contact all participants at day 14-post-discharge to recheck symptoms and, where possible, provide results of their environmental monitoring within one week of the return of the CO monitor. Those who are identified as having a raised CO level will be advised on the need to seek further medical treatment and on identifying/rectifying issues in their homes in line with current guidance from the NHS, gas distribution services, and the UKHSA (UKHSA, 2022). As part of environmental monitoring, participants will be asked to complete an online survey every day for 7 days to assess any potential symptoms experienced by themselves or other household residents. Headache characteristics will also be recorded. This will identify any distinguishable characteristics of headaches in patients with CO exposure. No geographical data or live locations can be recorded by the devices. The online survey will be sent to participants automatically using the Gather database via text message, and participants will also consent to being contacted by the research team to remind them to complete their data if the research team notices that it has not been completed. The option of completing paper questionnaires will be available to patients who would prefer this method, but online data collection should be advised as the preferred method of data collection, as this removes the risk of transcription error of source data. eCRFs also increase the likelihood of completion due to the capability to send electronic reminders. 5. CO monitor results follow-up All participants will be contacted by the study coordinator within 1 week of the return of the monitoring device to inform them of the results. This includes those who have no CO detected, as the researchers are aware that ‘not knowing’ may produce anxiety. Participants with suspected CO exposure will be contacted by the study coordinator at relevant points to enquire about the outcome of any remedial work done by gas engineers and any resolved or ongoing symptoms. Participants with ongoing symptoms will be advised to contact their GP. 6. Day 42 follow-up All participants will receive a follow-up telephone call with a member of the research team at 6 weeks post-discharge (± 7 days) to recheck symptoms and, if the participant had raised CO level, the results of any gas engineer checks or remedial work. 7. Safety follow-up Patients who are suspected to have been exposed to CO at any point during the study or have defective appliances or heating at home will be given CO safety advice in line with national guidance and offered instructional support on how to contact gas engineers. Suspected CO exposure will be defined as the following: - Raised COHb at hospital visit - Clinical suspicion of CO documented in medical records - Positive to either COMA_C or COMA_O - High levels of CO in environmental monitoring |
| Intervention type | Other |
| Primary outcome measure(s) |
Feasibility of the methodology will be measured by assessing the number of eligible versus enrolled patients, the data completeness from participants and the withdrawal/non-complete rates collected from study records throughout the trial and at the study endpoint |
| Key secondary outcome measure(s) |
1. The proportion of patients presenting to Emergency Departments with simple headaches who have been exposed to carbon monoxide (percentage), measured using data collected from study records at baseline. |
| Completion date | 01/06/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 110 Years |
| Sex | All |
| Target sample size at registration | 600 |
| Key inclusion criteria | 1. ‘Walk in’ adult patients ≥ 18yrs 2. Presenting with symptoms of headache (either as the main symptom or as part of a cluster of symptoms). This includes patients with suspected CO exposure. 3. Willing and able to give informed consent for participation in the study 4. Willing and able to return the study CO monitor within 5 days of the end of the CO monitoring period 5. Likely to be discharged from the ED |
| Key exclusion criteria | 1. Children under the age of 18 years 2. Headache precipitated by another condition, e.g. head trauma or stroke 3. Clinical condition warranting immediate or urgent medical assessment 4. Patients lacking the capacity to provide informed consent |
| Date of first enrolment | 01/12/2025 |
| Date of final enrolment | 01/05/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
London
SW17 0RE
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/09/2025: Study's existence confirmed by the CO Research Trust, UK.