Detecting low brain oxygen levels in patients undergoing non-cardiac surgery to assess its association with post-operative delirium
| ISRCTN | ISRCTN15439489 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15439489 |
| Protocol serial number | 1.31 |
| Sponsor | Royal Surrey County Hospital |
| Funder | Medtronic |
- Submission date
- 29/08/2018
- Registration date
- 06/11/2018
- Last edited
- 22/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims (brief description of the disease or area of study, what are the objectives/aim of the study)
The aim is to explore the use of a novel monitor, during general anaesthesia and surgery, that non-invasively measures the levels of oxygen in the brain. We will also look for the uncommon complication of delirium occurring early in the postoperative period.
Who can participate? (what are the age range and gender of the participants, can they only participate if they have a certain condition or if they are healthy volunteers?)
Specific patients having surgery at this hospital will be approached.
What does the study involve? (what interventions will be compared, will all participants receive the same treatment?)
The use of a new monitor before, during and for one hour after surgery.
What are the possible benefits and risks of participating? (what can participants gain from enrolling, are there any side effects of the treatments and if so, what are the symptoms?)
No potential benefit. Trivial risk of having allergic to the adhesive on the sensor.
Where is the study run from? (what are the approximate number and names of centres taking part in this trial, if there is a lead centre, which one is it?)
Royal Surrey County Hospital NHS Foundation Trust
When is the study starting and how long is it expected to run for? (what is the anticipated start date and the approximate duration of the trial?)
September 2018 to January 2019
Who is funding the study? (who will be paying the costs that the trial will incur during its lifecycle?)
Medtronic, the manufacturer of the sensors and device.
Who is the main contact? (if this is the same as the contact in the record, please provide the name and email address only, if different to the contact in the record, please provide the name, position they hold at the institution/organisation and their email address)
Ben Creagh-Brown, bencb@nhs.net
Contact information
Public
Royal Surrey County Hospital
Guildford
GU27XX
United Kingdom
| 0000-0002-4397-1232 |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Using near-infrared spectroscopy to detect cerebral desaturation in non-cardiac surgery and assess its relationship with post-operative delirium– a pilot study |
| Study acronym | CereOx |
| Study objectives | Low baseline cerebral oximetry values, or some metric of peri-operative cerebral desaturation may be more closely associated with post-operative delirium than other variables including systemic blood pressure. |
| Ethics approval(s) | London - Bloomsbury Research Ethics Committee reviewed the above application on 21 June 2018. REC reference: 18/LO/1122 |
| Health condition(s) or problem(s) studied | Postoperative delirium |
| Intervention | Measurement of cerebral oximetry, from entering the anaesthetic room to 1 hour after the end of surgery |
| Intervention type | Device |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
The following will be assessed once the final participant has finished the study (as these measurements require the total number of patients): |
| Key secondary outcome measure(s) |
For each cohort of surgical patients, and the cohort as a whole, use descriptive statistics (proportion (%), or mean and standard deviation, or median and interquartile range – according to parametric or non-parametric distribution respectively): |
| Completion date | 01/02/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | Patients: 1. Age ≥ 60 2. Able to provide informed consent Surgical types: 1. Scheduled orthopaedic surgery (GA/sedation +/- regional) 2. Scheduled gastrointestinal surgery (open/closed) 3. Scheduled robotic urological or gynaecological surgery 4. Emergency laparotomy surgery |
| Key exclusion criteria | 1. Acute or chronic cognitive impairment, including delirium or dementia 2. Previous neurosurgery 3. Insufficient English language to discuss participation |
| Date of first enrolment | 03/09/2018 |
| Date of final enrolment | 01/01/2019 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Guildford
GU2 7XX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/06/2021 | 22/03/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
22/03/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
25/02/2019: internal review.
23/11/2018: Internal review.