VERVE v1
Research type
Research Study
Full title
Assessing the accuracy of Seismofit® as an estimate of VO2 max in patients with hepato-pancreato-biliary, colorectal and gastro-oesophageal cancer
IRAS ID
309212
Contact name
Donald Milliken
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
A patient’s ability to exercise is related to their risks of having major surgery. This is currently measured by performing cardiopulmonary exercise testing (CPET), which involves cycling on a fixed bike. It provides clinicians with many observations, including peak oxygen consumption (VO2 peak), a measure of fitness which has been shown to predict a patient’s risk of complications after major surgery. We want to know if there is another way to estimate VO2 peak that is more comfortable for patients, cheaper and simpler.
The study will investigate patients having planned surgery for stomach, oesophageal, bowel, liver, gall bladder and pancreas cancer. These patients can often be at high risk for surgery, and estimating their VO2 is more complicated due to changes to how they metabolise oxygen.
We are investigating a device called Seismofit which is placed on the chest of a patient while they lying flat for three minutes, which estimates VO2 peak. The accuracy of this device has not yet been evaluated in cancer patients. Patients will have a Seismofit estimate of VO2 peak followed by measurement by the traditional method of CPET. We will then compare the results to determine how accurate a predictor of VO2 peak Seismofit is.
Only patients who are already planned to have CPET as part of their routine investigations will be asked to participate. Seismofit measurement will be undertaken prior to their CPET. Clinicians involved in their care will not know their Seismofit measurement.
We will compare the Seismofit estimate of VO2 against, CPET-measured VO2 to ascertain how well Seismofit predicts VO2 peak. We will also investigate whether it predicts VO2 peak better in any particular group of cancer. Finally we will compare the patient experience of Seismofit compared to CPET by asking three questions for each test, on a scale of 1-5.
REC name
North West - Preston Research Ethics Committee
REC reference
22/NW/0385
Date of REC Opinion
13 Jan 2023
REC opinion
Further Information Favourable Opinion