The role of autonomic responses to cardiopulmonary exercise testing in predicting surgical outcome in non-cardiac surgical patients

ISRCTN	ISRCTN88456378
DOI	https://doi.org/10.1186/ISRCTN88456378
Secondary identifying numbers	13695

Submission date: 19/02/2014
Registration date: 22/08/2014
Last edited: 04/03/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
An important minority of patients develop complications after surgery. These complications can include infections, heart attacks, heart damage and damage to other organs, such as the kidney or brain. It is thought that it may be possible to predict which patients will go on to develop these complications before they undergo surgery. Such knowledge would allow doctors to take steps to reduce the medical risks of surgery. It would also aid the development of future trials of different treatments aimed at reducing said risks. While we are aware of some of the reasons why complications are more likely to happen in some people after surgery, there are a number of potential factors that may increase the risk that are, as yet, not fully understood. Here, we are looking at how the brain controls the heart and immune system after surgery. In healthy people, the brain carefully controls how parts of the nervous system help control inflammation and heart function. After surgery, this control system can change and may contribute to the body not being able to heal or recover as well or as quickly as expected. By measuring nervous system and heart function, we will identify patterns that are linked to patients developing complications that cause problems with their recovery after surgery.

Who can participate?
All adult patients aged 18-95 referred for cardiopulmonary exercise testing (an exercise test that examines how the lungs, heart and muscles work) before undergoing major non-cardiac (i.e. not involving the heart) surgery

What does the study involve?
As part of the medical assessment process before major surgery, some patients have a cardiopulmonary exercise test. The aim of this test is to see how physically fit the patient is as well as other medical information. This can help doctors develop a treatment plan tailored to the needs of the patient. Each patient is asked to give a blood sample for analysis and their heart rate (ECG) measured before, during and after the exercise test. All patients are monitored throughout their hospital stay. Data about how they recover after surgery and their medical condition is recorded on days 3, 5, 7 and 14 after surgery. This study is observational, meaning that there are no changes to the medical or surgical treatment of patients involved.

What are the possible benefits and risks of participating?
There are no disadvantages/risks of taking part. The information we receive from this study may help us to treat patients who are having surgery in the future.

Where is the study run from?
University College London (UK)

When is the study starting and how long is it expected to run for?
March 2013 to March 2015

Who is funding the study?
Academy of Medical Sciences (UK)
Centre for Anaesthesia, Critical Care and Pain Management (UK)

Who is the main contact?
Dr Gareth Ackland
(See contact details below)

Contact information

Dr Gareth Ackland
Scientific

Wolfson Institute for Biomedical Research
Gower Street
London
WC1E 6BT
United Kingdom

Study information

Study design	Non-randomised; Observational; Design type: Cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Diagnostic
Scientific title	The role of autonomic responses to cardiopulmonary exercise testing in predicting surgical outcome in non-cardiac surgical patients: an observational cohort study
Study acronym	POM-HR
Study objectives	Patients with abnormal heart rate recovery have a prolonged length of stay postoperatively and greater postoperative morbidity.
Ethics approval(s)	12/LO/0453
Health condition(s) or problem(s) studied	Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Surgery, Anaesthetics
Intervention	No interventions, Observational; Follow Up Length: 0 month(s)
Intervention type	Procedure/Surgery
Primary outcome measure	Post-operative morbidity survey; Timepoint(s): Preop, postop days 3, 7, 14
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/03/2013
Completion date	01/03/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	95 Years
Sex	Both
Target number of participants	Planned Sample Size: 778; UK Sample Size: 778; Description: Elective non-cardiac surgical patients
Key inclusion criteria	1. All surgical patients referred for cardiopulmonary exercise testing preoperatively undergoing major non-cardiac surgery 2. Aged 18-95 years
Key exclusion criteria	1. History of exercise-induced angioedema 2. Pregnancy 3. Any contraindication to cardiopulmonary exercise testing (as outlined by American Association of Anaesthesia)
Date of first enrolment	01/03/2013
Date of final enrolment	01/03/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Wolfson Institute for Biomedical Research

London
WC1E 6BT
United Kingdom

Sponsor information

University College London Hospitals NHS Foundation Trust & University College London (UK)
University/education

Gower Street
London
WC1E 6BT
England
United Kingdom

"ROR"	https://ror.org/042fqyp44

Funders

Funder type

University/education

Academy of Medical Sciences (UK)
Private sector organisation / Other non-profit organizations

Alternative name(s): The Academy of Medical Sciences
Location: United Kingdom

Centre for Anaesthesia, Critical Care and Pain Management (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2017	22/01/2019	Yes	No
Results article	results	01/01/2018	22/01/2019	Yes	No
Other publications	secondary analysis	21/08/2019	04/03/2020	Yes	No

Editorial Notes

04/03/2020: Publication reference added.
22/01/2019: Publication references added.
11/05/2017: No publications found in PubMed, verifying study status with principal investigator.