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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05831488
Other study ID # CCR5651
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date March 1, 2024

Study information

Verified date January 2023
Source Royal Marsden NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 35
Est. completion date March 1, 2024
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age =18 2. Scheduled for elective surgery for resection of HPB, colorectal or gastro-oesophageal primary or secondary cancer 3. Undergoing CPET as part of routine pre-operative investigations Exclusion Criteria: 1. Subjects unable to give voluntary written informed consent to participate in this study 2. Diagnosis of moderate or worse stenosis or regurgitation of any cardiac valve 3. Previous aortic or mitral valve surgery, valvuloplasty or transcatheter valve implantation 4. Permanent pacemaker or cardiac resynchronisation device in situ 5. Diagnosis of severe pulmonary hypertension 6. Permanent atrial fibrillation

Study Design


Intervention

Other:
Non-Interventional
Non Interventional

Locations

Country Name City State
United Kingdom The Royal Marsden NHS Foundation Trust London

Sponsors (1)

Lead Sponsor Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
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