The Cost in Oxygen of Surgical Trauma

NCT02238561 | Completed

• 1 other identifier: 14/P/123
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will examine the relationship between post-operative oxygen consumption (using non-invasive measurement technology ) and complications in patients having contemporary major abdominal surgery. The investigators hypothesis is that major surgery may trigger a physiological stress response that results in an increase in post-operative metabolic demand and oxygen consumption (V̇O2) which must be met by an increased oxygen delivery (DO2).

1. 1.To determine the feasibility of non-invasive measurement of oxygen consumption (V̇O2) using indirect calorimetry in a cohort of patients
2. 2.To determine the feasibility of non-invasive measurement of oxygen delivery (DO2) in the same cohort using non-invasive measures of cardiac output, oxygen saturation and haemoglobin (pulse wave transit time and co-oximetry techniques)

Conditions

Oxygen Consumption (V̇O2); Oxygen Delivery (DO2); Post-operative Complications

Keywords

non-invasive; measurement of oxygen; consumption; delivery; post-operative complications

Outcome Measures

Primary Outcomes (1)

• postoperative morbidity score (POMS)

  The Post-Operative Morbidity Survey (POMS) is a simple outcome scale designed to record the incidence of clinically important complications - specifically complications likely to keep a patient in hospital. A POMS score performed on Day 5 is likely to be discriminative between patients who are recovering well, and those who are developing complications. POMS is easily performed, has good internal validity and is predictive of a prolonged length of stay. POMS is not a simple additive scale; however patients with POMS score of 1 or greater are highly likely to remain in hospital, whereas those with a score of 0 are likely to be able to go home.

  Day 5 post surgery

Secondary Outcomes (5)

• Length of hospital stay

  estimated average length of hospital stay of 5 - 7 days

• Unplanned admission to critical care.

  Participants will be followed for the duration of hospital stay, an expected average of 5 - 7 days

• Returns to the operating theatre

  Number of events during Hospital admission (estimated average length of hospital stay of 5 - 7 days)

• Hospital readmission

  Within 30 days of discharge from hospital

• Mortality

  Up to 30 days following hospital discharge

Study Arms (1)

Elective major abdominal surgery

Patients undergoing elective major open or laparoscopic abdominal surgery at Plymouth Hospitals National Health Service (NHS) Trust (PHNT)

Eligibility Criteria

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

Study Population

Patients undergoing elective major open or laparoscopic abdominal surgery at Plymouth Hospitals NHS Trust (PHNT)

You may qualify if:

• Male and female patients aged 18 or over.
• Undergoing elective major open or laparoscopic abdominal surgery.

You may not qualify if:

• Refusal to participate
• Requirement for post-operative ventilation
• Requirement of inspired oxygen concentrations (FiO2) \> 28% to maintain oxygen saturations ≥ 90%.

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead

Study Sites (1)

Plymouth Hospitals NHS Trust

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Study Officials

• Adam Kimble, BSc(Hons), MSc, MBBS, MRCS

  University Hospital Plymouth NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 12, 2014
• Study Start: November 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 30, 2015

Record last verified: 2015-02

Locations

GB (1)