Assessing the Accuracy of Seismofit® as an Estimate of VO2 Peak in Patients With Hepato-pancreato-biliary, Colorectal, and Gastro-oesophageal Cancer

Study Overview
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Brief Summary
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Our study aims to assess the relationship between the Seismofit® derived VO2 peak estimate and CPET-measured VO2 peak in patients who are having CPET as part of their preoperative workup. Our aim is to establish whether Seismofit® can be considered a cheaper, less resource intensive and better tolerated alternative to the CPET, or whether it might be useful as a screening tool to efficiently identify patients with exercise intolerance who may benefit from further characterisation by CPET.

Official Title
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Assessing the Accuracy of Seismofit® as an Estimate of VO2 Peak in Patients With Hepato-pancreato-biliary, Colorectal, and Gastro-oesophageal Cancer

Conditions
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Hepato-Biliary Carcinoma in Situ Nos, Pancreatic Cancer, Colorectal Cancer, Gastric Cancer, Oesophageal Cancer

Intervention / Treatment
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* Other: Non-Interventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 Scheduled for elective surgery for resection of HPB, colorectal or gastro-oesophageal primary or secondary cancer Undergoing CPET as part of routine pre-operative investigations Exclusion Criteria: Subjects unable to give voluntary written informed consent to participate in this study Diagnosis of moderate or worse stenosis or regurgitation of any cardiac valve Previous aortic or mitral valve surgery, valvuloplasty or transcatheter valve implantation Permanent pacemaker or cardiac resynchronisation device in situ Diagnosis of severe pulmonary hypertension Permanent atrial fibrillation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Non-Interventional|Non Interventional|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the relationship between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak in HPB, gastro-oesophageal or colorectal cancer patients undergoing preoperative assessment for major surgery. | Strength and direction of relationship (Pearson correlation coefficient) between Seismofit® -estimated VO2 peak and CPET-measured VO2 peak. | End of Trial (9 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess limits of agreement and bias between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak | Limits of agreement and bias between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak (Bland-Alman analysis) | End of Trial (9 months) | 
| Assess the relationship between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak in each surgical subgroup: HPB, gastro-oesophageal and colorectal cancer patients. | Strength and direction of relationship (Pearson correlation coefficient) between Seismofit® -estimated VO2 peak and CPET-measured VO2 peak, as well as limits of agreement and bias (Bland-Altman analysis) in each surgical subgroup: HPB, gastro-oesophageal and colorectal cancer patients. | End of Trial (9 months) | 
| Assess the relationship between Seismofit® -estimated VO2 peak and other CPET derived variables: o Anaerobic Threshold (AT) o Peak Power Output (PPO) o Ventilatory equivalents for carbon dioxide (VE/VCO2) | Strength and direction of relationship (Pearson correlation coefficient) between Seismofit® -estimated VO2 peak and the CPET-measured variables of AT, PPO and VE/VCO2 | End of Trial (9 months) | 
| Assess patient experience of the Seismofit® test using a brief measure that has been used previously in CPET research | Patient concern, comfort, and overall satisfaction of Seismofit® measurement compared with CPET. | End of Trial (9 months) |