Measuring preoperative fitness with a new device called Seismofit
The Validity of a Seismocardiography Device to Estimate Peak Oxygen Uptake in Patients Awaiting Major Elective Surgery
This study tests a new device called Seismofit to see if it can quickly and easily measure fitness levels in adults before they have major surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 143 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Northumbria University Academic / other |
| Locations | 3 sites (Middlesbrough and 2 other locations) |
| Trial ID | NCT05943730 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the Seismofit device in measuring preoperative fitness levels in adults awaiting major elective surgery. Unlike traditional exercise tests that require extensive equipment and effort, Seismofit estimates fitness by measuring chest wall vibrations while the patient is lying down. The goal is to determine if this quick, non-invasive method can accurately assess fitness and improve surgical outcomes. Participants will be adults who can perform a maximum effort cardiopulmonary exercise test (CPET) as part of their preoperative assessment.
Who should consider this trial
Good fit: Ideal candidates are adults awaiting major or complex elective surgery who are capable of performing a maximum effort CPET.
Not a fit: Patients with certain cardiac conditions, severe COPD, or significant obesity may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a faster and more accessible way to assess preoperative fitness, potentially improving recovery outcomes for patients.
How similar studies have performed: While traditional methods for measuring fitness have been well-established, the Seismofit device represents a novel approach that has not been widely tested in this specific patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion: * Adults awaiting major or complex elective surgery classified by the NICE NG45 guideline * Referred for and capable of performing a maximum effort CPET as part of standard care within their preoperative assessment * Able to be fully supine for 5 minutes Exclusion: * Pacemaker, implantable defibrillator, or any other implantable electronic device in situ * Permanent Atrial fibrillation, or other persistent arrhythmia (such as, atrial flutter, bigeminy, trigeminy, frequent premature atrial/ventricular complexes, 2nd degree heart block) documented in the patient's medical history * Body mass index (BMI) \>35 kg.m-2 * Severe COPD (defined as FEV1 % predicted \<50% \[GOLD report, 2022\]) * Pectus excavatum or other chest wall deformity * Claudication that limits exercise tolerance * Unable to perform maximal CPET * Refusal to give informed consent * Presence of an absolute contraindication to CPET detailed in the POETTS clinical guideline (Levett et al. 2018).
Where this trial is running
Middlesbrough and 2 other locations
- South Tees Hospitals NHS Foundation Trust — Middlesbrough, United Kingdom (Recruiting)
- Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, United Kingdom (Recruiting)
- York and Scarborough NHS Foundation Trust — York, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Alasdair O'Doherty, PhD
- Email: alasdair.odoherty@northumbria.ac.uk
- Phone: 01913495377
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.