VERVE: Assessing the Accuracy of Seismofit® as an Estimate of VO2 Peak in Patients With Hepato-pancreato-biliary, Colorectal, and Gastro-oesophageal Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- 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. [End of Trial (9 months)]
Strength and direction of relationship (Pearson correlation coefficient) between Seismofit® -estimated VO2 peak and CPET-measured VO2 peak.
Secondary Outcome Measures
- Assess limits of agreement and bias between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak [End of Trial (9 months)]
Limits of agreement and bias between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak (Bland-Alman analysis)
- Assess the relationship between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak in each surgical subgroup: HPB, gastro-oesophageal and colorectal cancer patients. [End of Trial (9 months)]
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.
- 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) [End of Trial (9 months)]
Strength and direction of relationship (Pearson correlation coefficient) between Seismofit® -estimated VO2 peak and the CPET-measured variables of AT, PPO and VE/VCO2
- Assess patient experience of the Seismofit® test using a brief measure that has been used previously in CPET research [End of Trial (9 months)]
Patient concern, comfort, and overall satisfaction of Seismofit® measurement compared with CPET.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18
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Scheduled for elective surgery for resection of HPB, colorectal or gastro-oesophageal primary or secondary cancer
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Undergoing CPET as part of routine pre-operative investigations
Exclusion Criteria:
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Subjects unable to give voluntary written informed consent to participate in this study
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Diagnosis of moderate or worse stenosis or regurgitation of any cardiac valve
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Previous aortic or mitral valve surgery, valvuloplasty or transcatheter valve implantation
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Permanent pacemaker or cardiac resynchronisation device in situ
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Diagnosis of severe pulmonary hypertension
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Permanent atrial fibrillation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Royal Marsden NHS Foundation Trust | London | United Kingdom | SM25PT |
Sponsors and Collaborators
- Royal Marsden NHS Foundation Trust
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CCR5651