Perioperative complications and autonomic function assessed by the COMPASS-31 tool
| ISRCTN | ISRCTN17277871 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17277871 |
| Integrated Research Application System (IRAS) | 328971 |
| PROSPERO | CRD420251175235 |
| Sponsor | Queen Mary University of London |
| Funders | King Saud bin Abdulaziz University for Health Science, Queen Mary University of London |
- Submission date
- 27/11/2025
- Registration date
- 18/12/2025
- Last edited
- 18/12/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
As people age, the nervous system becomes damaged, including the part responsible for controlling the speed at which the heart beats. This control is particularly important in patients undergoing surgery, where abnormal control can cause the organs of the body to not work properly and delay recovery from surgery. A loss of autonomic function (a condition where involuntary bodily functions like heart rate or digestion may not work properly) might increase the risk of infections and other complications after surgery. This research will help to identify ways that better predict and reduce these risks, ultimately improving the care and recovery of surgical patients.
The Composite Autonomic Symptom Score-31 (COMPASS-31) score may provide an in-depth assessment of these autonomic abnormalities in different organs before surgery. This scale includes up to 31 questions to identify organ dysfunction. However, preoperative COMPASS-31 has not been examined or related to how well patients recover after surgery.
This study aims to use a series of questions to see whether patients who are at most risk of complications can be identified before they have their surgery to improve surgical care in the future.
Who can participate?
Patients aged ≥ 50 years and over undergoing elective major noncardiac surgery under general anaesthesia and expected to require at least an overnight stay in hospital.
What does the study involve?
periCOMPASS-31 is an observational study, and the operation and usual care will proceed as planned. The research team will approach potentially eligible participants to discuss the study and obtain consent. The study involves the following additional steps:
Completion of the questionnaire before surgery
Participants will be asked to complete a short questionnaire, the Composite Autonomic Symptom Score-31 (COMPASS-31), about different aspects of how their body functions. It contains 12 to 31 questions, depending on your answers, and should take about 5 to 10 minutes to complete.
Heart rate monitoring
Participants will have their heart rate measured using a heart-rate monitor from the day of surgery until up to three days after their surgery. This device will help us measure changes in your heart rate and how your body responds to surgery.
Blood samples
A small blood sample (about three teaspoons) will be taken to check whether their heart shows signs of stress. Those results will not guide clinical care because this testing is not standard practice; instead, the results will be analysed at the end of the study. If participants agree, any remaining sample may be stored for closely related, future ethically approved research. Please note that participants can opt out of this.
What are the possible benefits and risks of participating?
The participants may not benefit directly from taking part. By taking part, participants help to find better ways to care for surgical patients in the future.
Blood sampling may cause minor discomfort, such as a small bruise or slight pain at the needle site. The adhesive heart-rate monitor may mildly irritate the skin, causing temporary redness or itching. These effects are generally mild and temporary.
The progress of each participant will be followed from consent and surgery to a 30-day check after the operation. No extra clinic visits are required.
Where is the study run from?
The study is coordinated by the Critical Care and Perioperative Medicine Research Group at Queen Mary University of London (UK), based at the William Harvey Research Institute, Charterhouse Square, London.
When is the study starting and how long is it expected to run for?
November 2025 to November 2027.
Who is funding the study?
1. King Saud bin Abdulaziz University for Health Sciences (SA)
2. Queen Mary University of London (UK)
Who is the main contact?
1. Main study contact (general enquiries): Clinical Trial and Research Manager Priyanthi Dias, Queen Mary University of London, p.dias@qmul.ac.uk.
2. Scientific lead: Chief Investigator Professor Gareth Ackland, William Harvey Research Institute, QMUL, g.ackland@qmul.ac.uk.
3. Sponsor queries: QMUL Joint Research Management Office, research.governance@qmul.ac.uk (Dr Mays Jawad).
Contact information
Scientific, Principal investigator
Translational Medicine & Therapeutics
Room 201A, 11-13 Charterhouse Buildings
Queen Mary University of London School of Medicine.
London
EC1M 6BQ
United Kingdom
 ORCID ID |
0000-0003-0565-5164 |
|---|---|
| Phone | +44 (0)20 3595 0351 |
| g.ackland@qmul.ac.uk |
Public
ACCU Research Offices
4th Floor, Office 14
Royal London Hospital
Whitechapel
London
E1 1FR
United Kingdom
| Phone | +44 (0)2035940349 |
|---|---|
| p.dias@qmul.ac.uk |
Public, Scientific
Translational Medicine & Therapeutics
Room 201A, 11-13 Charterhouse Buildings
Queen Mary University of London School of Medicine.
London
EC1M 6BQ
United Kingdom
| ORCID ID |
0000-0002-4091-1939 |
|---|---|
| Phone | +44 (0)77 7881 9527 |
| a.a.alotaibi@qmul.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multi-centre observational cohort study across surgical services in NHS hospitals. |
| Secondary study design | Cohort study |
| Participant information sheet | 48576 periCOMPASS-31 Patient Information Sheet v3.0.19092025.pdf |
| Scientific title | Perioperative complications and autonomic function assessed by the COMPASS-31 tool: multicentre, observational, mechanistic cohort study |
| Study acronym | periCOMPASS-31 |
| Study objectives | Primary objective: -To identify an association between infectious complications within 30 days of surgery and autonomic function before surgery using the Composite Autonomic Symptom Score-31 tool. Secondary objectives: -To identify an association between cardiovascular morbidity within 30 days of surgery and autonomic dysfunction before surgery using the Composite Autonomic Symptom Score-31. Mechanistic objectives: - To establish the relationship between frailty assessment and Composite Autonomic Symptom Score-31. - To establish the relationship between measures of heart rate variability and Composite Autonomic Symptom Score-31. -To explore the relationship between COMPASS-31 score, ex vivo inflammatory response in whole blood and infectious complications within 30 days of surgery. |
| Ethics approval(s) |
Approved 01/10/2025, Wales Research Ethics Committee 6 Swansea (Floor 4, Institute of Life Science 2, Swansea University, Swansea, SA2 8PP, United Kingdom; +44 (0)1792 295678; Wales.REC6@wales.nhs.uk), ref: 25/WA/0226 |
| Health condition(s) or problem(s) studied | Autonomic function in people undergoing major noncardiac surgery under general anaesthesia |
| Intervention | Composite Autonomic Symptom Score-31 within 30 days after surgery. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
Individual components of the COMPASS-31 questionnaire assessing autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor abnormalities collected prior to the participant undergoing surgery. |
| Completion date | 15/11/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 50 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 296 |
| Key inclusion criteria | 1. Patients aged ≥ 50 years and over undergoing elective major noncardiac surgery under general anaesthesia expected to require at least an overnight stay in hospital. |
| Key exclusion criteria | 1. Lack of capacity or refusal to provide written informed consent 2. Inability to complete questionnaires 2. American Society of Anesthesiologists (ASA) score of I |
| Date of first enrolment | 15/11/2025 |
| Date of final enrolment | 15/11/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
London
E1 1BB
England
London
SW3 6JJ
England
London
NW3 2QG
England
London
E13 8SL
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 | version 3.0 | 19/09/2025 | 18/12/2025 | No | Yes |
| Protocol file | version 1.0 | 08/07/2025 | 18/12/2025 | No | No |
Additional files
- 48576 periCompass-31 Protocol v1.0.08072025.pdf
- Protocol file
- 48576 periCOMPASS-31 Patient Information Sheet v3.0.19092025.pdf
- Participant information sheet
Editorial Notes
27/11/2025: Study's existence confirmed by Health Research Authority (HRA) (UK).
