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

Surgery Clinical Trial

Official title: The Use of Ventriject to Assess V02Max in Patients Admitted to Hospital in the Emergency Surgery Setting

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Emergencies
• Surgery

• NCT number: NCT06189131
• Study type: Interventional
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: Melissa Bautista
• Phone: 07557049753
• Email: M.J.Bautista@leeds.ac.uk
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2023
• Completion date: February 1, 2024