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NCT05943730

Validity of Measuring Preoperative Fitness Using Seismofit

Status unknown NA Last updated 6 March 2024
What this trial tests

NA trial testing Seismofit in Preoperative Care in 143 participants. Status unknown.

Timeline
31 August 2023
Primary endpoint
1 August 2024
1 August 2024

Quick facts

Lead sponsorNorthumbria University
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment143
Start date31 August 2023
Primary completion1 August 2024
Estimated completion1 August 2024
Sites3 locations across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Northumbria University

Who can join

Adults 18 to 100, any sex, with Preoperative Care or Validity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Preoperative Care

Currently open trials in the same condition.

Other Northumbria University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05943730.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing