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

Surgery Clinical Trial

— LESS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06189131
• Other study ID #: GS23/155862
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: December 2023
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: Melissa Bautista
• Phone: 07557049753
• Email: M.J.Bautista[@]leeds.ac.uk
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Surgery

Intervention

Device:
• Ventriject
Ventriject is a non-exercise method for estimating V02Max

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (9)

Devereaux PJ, Sessler DI. Cardiac Complications in Patients Undergoing Major Noncardiac Surgery. N Engl J Med. 2015 Dec 3;373(23):2258-69. doi: 10.1056/NEJMra1502824. No abstract available. — View Citation

Gupta H, Gupta PK, Fang X, Miller WJ, Cemaj S, Forse RA, Morrow LE. Development and validation of a risk calculator predicting postoperative respiratory failure. Chest. 2011 Nov;140(5):1207-1215. doi: 10.1378/chest.11-0466. Epub 2011 Jul 14. — View Citation

Jensen MB, Houborg KB, Norager CB, Henriksen MG, Laurberg S. Postoperative changes in fatigue, physical function and body composition: an analysis of the amalgamated data from five randomized trials on patients undergoing colorectal surgery. Colorectal Dis. 2011 May;13(5):588-93. doi: 10.1111/j.1463-1318.2010.02232.x. — View Citation

Lucas DJ, Pawlik TM. Quality improvement in gastrointestinal surgical oncology with American College of Surgeons National Surgical Quality Improvement Program. Surgery. 2014 Apr;155(4):593-601. doi: 10.1016/j.surg.2013.12.001. Epub 2013 Dec 14. — View Citation

Older P, Smith R, Courtney P, Hone R. Preoperative evaluation of cardiac failure and ischemia in elderly patients by cardiopulmonary exercise testing. Chest. 1993 Sep;104(3):701-4. doi: 10.1378/chest.104.3.701. — View Citation

Scholes RL, Browning L, Sztendur EM, Denehy L. Duration of anaesthesia, type of surgery, respiratory co-morbidity, predicted VO2max and smoking predict postoperative pulmonary complications after upper abdominal surgery: an observational study. Aust J Physiother. 2009;55(3):191-8. doi: 10.1016/s0004-9514(09)70081-9. — View Citation

Sorensen K, Schmidt SE, Jensen AS, Sogaard P, Struijk JJ. Definition of Fiducial Points in the Normal Seismocardiogram. Sci Rep. 2018 Oct 18;8(1):15455. doi: 10.1038/s41598-018-33675-6. Erratum In: Sci Rep. 2020 Sep 4;10(1):14822. — View Citation

Steffens D, Ismail H, Denehy L, Beckenkamp PR, Solomon M, Koh C, Bartyn J, Pillinger N. Preoperative Cardiopulmonary Exercise Test Associated with Postoperative Outcomes in Patients Undergoing Cancer Surgery: A Systematic Review and Meta-Analyses. Ann Surg Oncol. 2021 Nov;28(12):7120-7146. doi: 10.1245/s10434-021-10251-3. Epub 2021 Jun 8. — View Citation

Wilson RJ, Davies S, Yates D, Redman J, Stone M. Impaired functional capacity is associated with all-cause mortality after major elective intra-abdominal surgery. Br J Anaesth. 2010 Sep;105(3):297-303. doi: 10.1093/bja/aeq128. Epub 2010 Jun 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ability for Ventriject to detect a V02Max value in individual patients	VO2 Max	7 days
Secondary	The acceptability of the device to patients	The acceptability of the device to patients	7 days
Secondary	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	The correlation between V02Max with the patient clinical conditions and outcomes	7 days
Secondary	The correlation between V02Max with the patients NEWS score, blood results, clinical deterioration, ASA grade, PPOSSUM score, NELA score & Clavien Dindo Classification	The correlation between V02Max with the patient clinical conditions and outcomes	7 days

External Links

•   national-bowel-cancer-audit-annual-report-2017