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Contact Information:

Study Location:

Plymouth Hospitals NHS Trust
Plymouth
Devon
PL6 8DH


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The Cost in Oxygen of Surgical Trauma

Completed

Open to: All Genders

Age: 18 Years - N/A

Medical Conditions

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


Study 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. To determine the feasibility of non-invasive measurement of oxygen consumption (V̇O2) using indirect calorimetry in a cohort of patients

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)

Prospective observational study of non-invasive measurements of V̇O2 and DO2 pre-operatively and at 8 time points in the 48 hours postoperatively in a cohort of 40 patients undergoing elective major abdominal surgery (both open and laparoscopic) with a pre-operative cardiopulmonary exercise testing (CPET).

As pilot work examining the relationship between post-operative oxygen consumption and complications in patients having contemporary major abdominal surgery , the investigators need to define and grade the severity of complications. 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.


Key dates

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Nov 2014

Aug 2015

Study type

Observational

Who can take part?

You can take part if:


Inclusion Criteria:

- Male and female patients aged 18 or over.

- Undergoing elective major open or laparoscopic abdominal surgery.

Exclusion Criteria:

- Refusal to participate

- Requirement for post-operative ventilation

- Requirement of inspired oxygen concentrations (FiO2) > 28% to maintain oxygen saturations ≥ 90%.




You may not be able to take part if:

This is in the inclusion criteria above


Where can I take part?

Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Plymouth Hospitals NHS Trust
    Plymouth
    Devon
    PL6 8DH

Funders/Sponsors


The study is sponsored by University Hospital Plymouth NHS Trust .



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for Trial ID: NCT02238561

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