Clinical trial NCT02238561: The Cost in Oxygen of Surgical Trauma
Official title: The Cost in Oxygen of Surgical Trauma (CO2ST) - a Feasibility Study of the Non-invasive Measurement of Oxygen Delivery and Consumption After Major Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxygen Consumption (V̇O2)
Oxygen Delivery (DO2)
Post-operative Complications
Keywords: non-invasive
measurement of oxygen
consumption
delivery
post-operative complications
Lead sponsor: University Hospital Plymouth NHS Trust
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective major open or laparoscopic abdominal surgery at Plymouth Hospitals NHS Trust (PHNT)

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. 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)

Detailed description: 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.

Eligibility criteria: 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%.

Primary outcomes:
measure: postoperative morbidity score (POMS)
timeFrame: Day 5 post surgery
Secondary outcomes:
measure: Length of hospital stay
timeFrame: estimated average length of hospital stay of 5 - 7 days
measure: Unplanned admission to critical care.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 - 7 days
measure: Returns to the operating theatre
timeFrame: Number of events during Hospital admission (estimated average length of hospital stay of 5 - 7 days)
measure: Hospital readmission
timeFrame: Within 30 days of discharge from hospital
measure: Mortality
timeFrame: Up to 30 days following hospital discharge
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust
state: Devon
Study officials:
affiliation: University Hospital Plymouth NHS Trust
name: Adam Kimble, BSc(Hons), MSc, MBBS, MRCS
role: PRINCIPAL_INVESTIGATOR
References: