Condition category
Surgery
Date applied
19/02/2014
Date assigned
22/08/2014
Last edited
28/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gareth Ackland

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13695

Study information

Scientific title

The role of autonomic responses to cardiopulmonary exercise testing in predicting surgical outcome in non-cardiac surgical patients: an observational cohort study

Acronym

POM-HR

Study hypothesis

Heart rate response to exercise and heart rate recovery from exercise reflect autonomic control of heart rate and predict prognosis; both of these parameters can be obtained from patients' preoperative cardiopulmonary exercise tests. We hypothesise that patients with abnormal heart rate recovery have a prolonged length of stay postoperatively and greater postoperative morbidity.

More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13695

Ethics approval

12/LO/0453

Study design

Non-randomised; Observational; Design type: Cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Post-operative morbidity survey; Timepoint(s): Preop, postop days 3, 7, 14

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/2013

Overall trial end date

01/03/2015

Reason abandoned

Eligibility

Participant inclusion criteria

All surgical patients referred for cardiopulmonary exercise testing preoperatively undergoing major non-cardiac surgery
Target Gender: Male & Female; Upper Age Limit 95 years ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 778; UK Sample Size: 778; Description: Elective non-cardiac surgical patients

Participant exclusion criteria

1. History of exercise-induced angioedema
2. Pregnancy
3. Any contraindication to cardiopulmonary exercise testing (as outlined by American Association of Anaesthesia)

Recruitment start date

01/03/2013

Recruitment end date

01/03/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wolfson Institute for Biomedical Research
London
WC1E 6BT
United Kingdom

Sponsor information

Organisation

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

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Academy of Medical Sciences (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes