Clinical trial NCT05943730: Validity of Measuring Preoperative Fitness Using Seismofit
Official title: The Validity of a Seismocardiography Device to Estimate Peak Oxygen Uptake in Patients Awaiting Major Elective Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preoperative Care
Validity
Keywords: Seismocardiography
Preoperative Exercise
Peak oxygen uptake
VO2max
Cardiopulmonary exercise test
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: South Tees Hospitals NHS Foundation Trust
name: Sheffield Teaching Hospitals NHS Foundation Trust
name: York Teaching Hospitals NHS Foundation Trust
name: VentriJect ApS
name: Aalborg University
First posted: 2023-07-13
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Physical fitness levels of people waiting for a planned operation are often measured using an exercise test. This is because fitness levels help doctors make a plan to improve each person's chances of a successful recovery after their planned operation. The exercise test requires skilled staff, expensive equipment, a 1 hour appointment, and the patient to exercise heavily during the test.

Ventriject, a small to medium sized enterprise, have designed a device called Seismofit that estimates fitness levels of people from a measurement taken whilst laying down. It measures the vibrations of the chest wall caused by the beating heart and uses this information with additional information, such as height, weight and sex, to estimate fitness. The measurement takes around 5 minutes to perform, does not require heavy exercise, expensive equipment or skilled staff.

The Seismofit device was shown to be accurate in young fairly fit people. It has not been tested in people who undergo an exercise test before an operation, who are less fit on average compared to the people that the device was originally tested on. It is likely that the calculations used to estimate fitness levels with the Seismofit device will need to be adjusted for people waiting for an operation. There are two parts to this study. The first part aims to estimate up to 50 people's fitness with the Seismofit device and use directly measured fitness from their standard exercise test before their operation to adjust the calculations for estimating fitness. The second part of this study aims to have a further 50 people undergo the Seismofit device measurement and compare the estimated fitness level with the results from the standard exercise test before an operation. This is to see if the Seismofit device is valid at estimating fitness in people awaiting surgery.


Eligibility 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).

Primary outcomes:
measure: Phase 1 outcome - refine algorithm
timeFrame: Up to 6 months
measure: Phase 2 outcome - validity of refined algorithm
timeFrame: 12 months
Secondary outcomes:
measure: Bland-Altman analysis
timeFrame: 12 months
measure: Existing V̇O2peak predicted equation analysis
timeFrame: 12 months
Other outcomes:
measure: Seismofit total population analysis
timeFrame: 12 months
Locations:
city: Middlesbrough
country: United Kingdom
facility: South Tees Hospitals NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
city: York
country: United Kingdom
facility: York and Scarborough NHS Foundation Trust
Study officials:
References: