Validity of Measuring Preoperative Fitness Using Seismofit

Preoperative Care Clinical Trial

Official title:

The Validity of a Seismocardiography Device to Estimate Peak Oxygen Uptake in Patients Awaiting Major Elective Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05943730
• Other study ID #: 1614
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: June 2023
• Source: Northumbria University
• Contact: Alasdair O'Doherty, PhD
• Phone: 01913495377
• Email: alasdair.odoherty[@]northumbria.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 143
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Preoperative Care
• Validity

Intervention

Device:
• Seismofit
The Seismofit device uses seismocardiography to estimate peak oxygen consumption from a resting measurement. This study will assess its validity against the gold standard measure of peak oxygen consumption, cardiopulmonary exercise test, conducted as part of standard care.

Locations

Country	Name	City	State
United Kingdom	South Tees Hospitals NHS Foundation Trust	Middlesbrough
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield
United Kingdom	York and Scarborough NHS Foundation Trust	York

Sponsors (6)

Lead Sponsor	Collaborator
Northumbria University	Aalborg University, Sheffield Teaching Hospitals NHS Foundation Trust, South Tees Hospitals NHS Foundation Trust, Ventriject, Denmark, York Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Seismofit total population analysis	Correlation between Seismofit estimated V?O2peak (ml/kg/min) and CPET measured V?O2peak (ml/kg/min), including patients that did not meet maximum effort criteria for CPET (RER >1.10 or <10 beats/min estimated maximum heart rate).	12 months
Primary	Phase 1 outcome - refine algorithm	Up to 50 patients awaiting major surgery will have their estimated V?O2peak (ml/kg/min) recorded using the Seismofit device and actual V?O2peak (ml/kg/min) measured in their standard preoperative cardiopulmonary exercise test. The Seismofit algorithm will be adjusted using these data points with machine learning.	Up to 6 months
Primary	Phase 2 outcome - validity of refined algorithm	The correlation between the new seismofit algorithm estimate of V?O2peak (ml/kg/min) and CPET measured and verified V?O2peak (ml/kg/min) in up to 50 preoperative patients that have valid tests in accordance with maximal exercise test criteria stated in the protocol (RER > 1.10 or maximum heart rate attained within 10 beats of predicted maximum).	12 months
Secondary	Bland-Altman analysis	Agreement between Seismofit estimated V?O2peak (ml/kg/min) and CPET measured V?O2peak (ml/kg/min) using Bland-Altman analysis.	12 months
Secondary	Existing V?O2peak predicted equation analysis	To calculate the correlation and agreement between existing equations used to predict V?O2peak (ml/kg/min) with directly measured V?O2peak (ml/kg/min) to observe how these data compare with the Seismofit correlation and agreement data.	12 months