The Use of Ventriject to Assess V02Max in Patients Admitted to Hospital in the Emergency Surgery Setting (LESS)

March 14, 2025 updated by: The Leeds Teaching Hospitals NHS Trust
The aim of this study is to assess whether Ventriject V02Max can provide values in a clinical setting and whether this value correlates with clinical outcome in patients admitted to the emergency general surgery department in a single centre. We will also be assessing the acceptability of the device to patients and clinicians.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Pre-operative risk stratification is an important aspect of clinical decision-making in patients undergoing surgery. Thorough pre-operative assessment aids in the evaluation of mortality and morbidity on an individual basis and enhances the process of shared decision-making. This is particularly important in emergency surgery, which is associated with higher morbidity and mortality than elective surgery. Emergency general surgery accounts for approximately 11% of surgical cases but represents 47% of all surgical related deaths and 28% of complications. Colorectal cancer surgery has demonstrated a 90-day mortality rate of 3.2% (NBOCA 2017) and is associated with complication rates of up to 30% (Luca et al 2014). In the emergency setting, the 90-day mortality after bowel cancer surgery rises to 8.7% (NBOCA 2021).

Cardiorespiratory fitness (CRF) is an independent risk factor for mortality and morbidity for individuals undergoing surgery (Older et al, Wilson et al). Cardiorespiratory complications are the leading cause of death in non-cardiac surgery (Devereaux et al 2015, Gupta et al 2011). The insult of surgery can cause a 40% reduction in CRF for individuals with a hospital stay of up to 9 days and only half of patients regain their CRF after 6 months (Jensen et al 2011).

Cardiopulmonary exercise testing (CPET) is an exercise stress test used before planned surgery to aid risk stratification of individual patients. The CPET test involves a treadmill exercise or cycle ergometry to assess anaerobic threshold (AT) and the peak oxygen uptake (V02 peak) (Older et al 2017. CPET is a method of quantifying CRF. CPET testing is limited in certain patient populations, such as those with a physical disability or arthritis. It is time-consuming, taking approximately 40-60 minutes per assessment. A survey of patients' experiences of CPET testing was conducted by Boyd in 2016. Several aspects of CPET were described as a "serious problem" and these included dryness in mouth (11%), muscle soreness (10%), being uncomfortable (8-9%) and coughing (9%). Generally, patients requiring emergency surgery will be too unwell to preform CPET testing, but also the combination of access to facilities and the time constraints of emergency surgery make CPET testing in an emergency scenario inappropriate.

Currently there are several scoring tools used to assess a patient's risk of surgery in the emergency setting, which include PPOSSUM and NELA. These scoring tools aid in the risk stratification of mortality and morbidity to aid in the decision making for clinicians and patients. Patient characteristics integrated in these scoring tools include evidence of cardiorespiratory dysfunction assessed on ECG and clinical evidence, blood pressure, heart rate and blood test results. However, there currently is no established method of measuring CRF in the emergency setting.

Ventriject is a non-exercise method for estimating V02Max. V02Max is defined as the metabolic rate at which oxygen uptake plateaus despite further increases in work rate and this maximum end point is rarely reached during CPET examinations. V02Max has been shown to relate to post operative outcomes (Scholes et al 2009).

Ventriject uses seismocardiography (SCG) signals generated by the vibrations from a beating heart, picked up by a small accelerometer placed on the chest. SCG is an alternative method of assessing cardiac function (Sorensen et al). V02Max is estimated from the SCG signal and patient demographics including gender, age, height and weight, using machine learning. Ventriject has been tested against CEPT in over 400 healthy subjects and has been found to closely correlate with V02Max measurements (0.80, p<0.001). This is the closest correlation to ergometer testing when compared to alternative methods.

It is estimated that each Ventriject assessment costs approximately £15 and takes a total of 120 seconds to complete. It requires no physical exercise and may be more acceptable in certain clinical situations and patient groups. Currently, Ventriject has been used in non-clinical settings and lacks evidence as to its usability in the clinical environment. Given the advantages of a cheap, rapid, and accessible method of measuring V02Max, Ventriject would be an appropriate method for measuring CRF in the emergency setting and may compliment the current risk stratification tools to aid in the clinical decision making around emergency surgery.

The aim of this study is to assess whether Ventriject V02Max can provide values in a clinical setting and whether this value correlates with clinical outcome in patients admitted to the emergency general surgery department in a single centre. We will also be assessing the acceptability of the device to patients and clinicians.

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Leeds, United Kingdom
        • Leeds Teaching Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults (>18 years of age)
  • Admitted under the General Surgery team within the last 24- 48 hours
  • Anticipated hospital stay of a minimum of 48 hours

Exclusion Criteria:

Patients who are unable to consent for participation in the study for any reason.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Acutely admitted surgical patients with no planned surgery
This cohort of individuals will be those admitted to the EGS department with a surgical pathology but who have not undergone surgery during the admission and by the end of data collection (7 days) (e.g. pancreatitis, conservative management intra-abdominal pathology). The rationale behind recruiting this cohort of patients is to assess the admission V02Max and how unwell patients are during their admission by correlating this result to their NEWS score, blood results and any evidence of clinical deterioration. This cohort of patients will help us understand whether V02Max correlates with patient's clinical conditions and outcomes.
Device: Ventriject
Ventriject is a non-exercise method for estimating V02Max
Experimental: Group 2: Acutely admitted surgical patients who have undergone an emergency procedure
Pre and post-operative Ventriject V02Max values will be taken in this group of patients to assess whether pre-operative V02Max correlates with pre-operative PPOSSUM, NELA scores and post-operative outcomes. This group of participants will answer whether acute V02Max is reflective of operative outcomes and whether it correlates with current methods of risk stratification (PPOSSUM, NELA, ASA) and post-operative outcome scores (Clavien-Dindo classification). This group is important as it will help establish whether V02Max measurements in the acute setting for operative risk stratification is feasible.
Device: Ventriject
Ventriject is a non-exercise method for estimating V02Max

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The ability for Ventriject to detect a V02Max value in individual patients
Time Frame: 7 days
VO2 Max
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The acceptability of the device to patients
Time Frame: 7 days
The acceptability of the device to patients
7 days
The correlation between V02Max with the patients NEWS score, blood results, clinical deterioration & ASA grade. Group 2: The above in addition, PPOSSUM score, NELA score, Clavien Dindo Classification
Time Frame: 7 days
The correlation between V02Max with the patient clinical conditions and outcomes
7 days
The correlation between V02Max with the patients NEWS score, blood results, clinical deterioration, ASA grade, PPOSSUM score, NELA score & Clavien Dindo Classification
Time Frame: 7 days
The correlation between V02Max with the patient clinical conditions and outcomes
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Leeds Teaching Hospitals NHS Trust

Investigators

  • Principal Investigator: Melissa Bautista, Leeds Teaching Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2023

Primary Completion (Estimated)

November 11, 2025

Study Completion (Estimated)

November 11, 2025

Study Registration Dates

First Submitted

September 26, 2023

First Submitted That Met QC Criteria

December 19, 2023

First Posted (Actual)

January 3, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 14, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS23/155862

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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