Preoperative CareNCT05943730
Validity of Measuring Preoperative Fitness Using Seismofit
A study testing Seismofit in people with Preoperative Care and Validity, run by Northumbria University at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Preoperative Care, Validity
- What is being tested?
- Seismofit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 31 Aug 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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).
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
South Tees Hospitals NHS Foundation Trust
Middlesbrough
Reema Ayyash, reema.ayyash@nhs.net
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
Alexander Kojro, a.kojro@nhs.net
- Recruiting
York and Scarborough NHS Foundation Trust
York
Simon Davies, MB ChB FRCA, 01904 726996, yhs-tr.research.governance@nhs.net
About this study
Official title: The Validity of a Seismocardiography Device to Estimate Peak Oxygen Uptake in Patients Awaiting Major Elective Surgery
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.
- Conditions
- Preoperative Care, Validity
- Being tested
- Seismofit
- Keywords
- Seismocardiography, Preoperative Exercise, Peak oxygen uptake, VO2max, Cardiopulmonary exercise test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeismofitDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Seismofit Validity | Experimental | Participants will undergo a seismocardiography assessment, whilst supine, using the seismofit device. This will estimate their peak oxygen consumption. Participants will then undergo a maximal cardiopulmonary exercise test (CPET), where peak oxygen consumption will be measured. The Seismofit estimated peak oxygen consumption will be compared with CPET measured peak oxygen consumption (unless prespecified criteria for a maximal exercise test are not met). Receives: Device: Seismofit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 outcome - refine algorithm
Up to 50 patients awaiting major surgery will have their estimated V̇O2peak (ml/kg/min) recorded using the Seismofit device and actual V̇O2peak (ml/kg/min) measured in their standard preoperative cardiopulmonary exercise test. The Seismofit algorithm will be adjusted using these data points with machine learning.
Measured: Up to 6 months
Phase 2 outcome - validity of refined algorithm
The correlation between the new seismofit algorithm estimate of V̇O2peak (ml/kg/min) and CPET measured and verified V̇O2peak (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).
Measured: 12 months
Secondary outcomes (2)
Bland-Altman analysis
Agreement between Seismofit estimated V̇O2peak (ml/kg/min) and CPET measured V̇O2peak (ml/kg/min) using Bland-Altman analysis.
Measured: 12 months
Existing V̇O2peak predicted equation analysis
To calculate the correlation and agreement between existing equations used to predict V̇O2peak (ml/kg/min) with directly measured V̇O2peak (ml/kg/min) to observe how these data compare with the Seismofit correlation and agreement data.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start31 Aug 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- South Tees Hospitals NHS Foundation Trust, Sheffield Teaching Hospitals NHS Foundation Trust, York Teaching Hospitals NHS Foundation Trust, VentriJect ApS, Aalborg University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943730
- Sponsor's protocol ID
- 1614
- Status last verified
- Jun 2023
- First submitted
- 4 Jul 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity of a Seismocardiography Device to Estimate Peak Oxygen Uptake in Patients Awaiting Major Elective Surgery
- ClinicalTrials.gov ID
- NCT05943730
- Acronym / sponsor ID
- 1614
- Conditions
- Preoperative Care, Validity
- Keywords
- Seismocardiography, Preoperative Exercise, Peak oxygen uptake, VO2max, Cardiopulmonary exercise test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- South Tees Hospitals NHS Foundation Trust, Sheffield Teaching Hospitals NHS Foundation Trust, York Teaching Hospitals NHS Foundation Trust, VentriJect ApS, Aalborg University
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seismofit Validity | Experimental | Device: SeismofitParticipants will undergo a seismocardiography assessment, whilst supine, using the seismofit device. This will estimate their peak oxygen consumption. Participants will then undergo a maximal cardiopulmonary exercise test (CPET), where peak oxygen consumption will be measured. The Seismofit estimated peak oxygen consumption will be compared with CPET measured peak oxygen consumption (unless prespecified criteria for a maximal exercise test are not met). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeismofitThe 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. | Device | Seismofit Validity |
Primary outcome
Phase 1 outcome - refine algorithm
Time frame: Up to 6 months
Up to 50 patients awaiting major surgery will have their estimated V̇O2peak (ml/kg/min) recorded using the Seismofit device and actual V̇O2peak (ml/kg/min) measured in their standard preoperative cardiopulmonary exercise test. The Seismofit algorithm will be adjusted using these data points with machine learning.
Phase 2 outcome - validity of refined algorithm
Time frame: 12 months
The correlation between the new seismofit algorithm estimate of V̇O2peak (ml/kg/min) and CPET measured and verified V̇O2peak (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).
2 secondary outcomes
Bland-Altman analysis
Time frame: 12 months
Existing V̇O2peak predicted equation analysis
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seismofit in people with Preoperative Care and Validity, run by Northumbria University at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alasdair O'Doherty, PhD (01913495377, alasdair.odoherty@northumbria.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 outcome - refine algorithm (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.