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

NCT06189131 | Suspended

• 1 other identifier: GS23/155862
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Emergencies; Surgery

Outcome Measures

Primary Outcomes (1)

• The ability for Ventriject to detect a V02Max value in individual patients

  VO2 Max

  7 days

Secondary Outcomes (3)

• 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

  7 days

• The correlation between V02Max with the patients NEWS score, blood results, clinical deterioration, ASA grade, PPOSSUM score, NELA score & Clavien Dindo Classification

  7 days

Study Arms (2)

Group 1: Acutely admitted surgical patients with no planned surgery

EXPERIMENTAL

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

Group 2: Acutely admitted surgical patients who have undergone an emergency procedure

EXPERIMENTAL

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

Interventions

Ventriject DEVICE

Ventriject is a non-exercise method for estimating V02Max

Group 1: Acutely admitted surgical patients with no planned surgery; Group 2: Acutely admitted surgical patients who have undergone an emergency procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Location

Related Publications (9)

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  PMID: 24508118 BACKGROUND

• 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.

  PMID: 20148922 BACKGROUND

• 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.

  PMID: 34101066 BACKGROUND

• 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.

  PMID: 19681741 BACKGROUND

• 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.

  PMID: 20573634 BACKGROUND

• 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.

  PMID: 8365279 BACKGROUND

• 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.

  PMID: 30337579 BACKGROUND

• 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.

  PMID: 26630144 BACKGROUND

• 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.

  PMID: 21757571 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Melissa Bautista

  Leeds Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participants will be divided into two groups and allocation to the relevant group is based on whether the patient has required a surgical intervention during the study period. This determines which outcomes are relevant and reflects two important groups of patients admitted to emergency general surgery. The allocation to each group is finalised following completion of the data collection as the decision for operative management or conservative manage of certain pathologies can change.

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: January 3, 2024
• Study Start: November 3, 2023
• Primary Completion: November 11, 2025
• Study Completion: November 11, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)