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The Cost in Oxygen of Surgical Trauma

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02238561
Enrollment
40
Registered
2014-09-12
Start date
2014-11-30
Completion date
2015-08-31
Last updated
2015-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Sponsors

University Hospital Plymouth NHS Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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%.

Design outcomes

Primary

MeasureTime frameDescription
postoperative morbidity score (POMS)Day 5 post surgeryThe 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.

Secondary

MeasureTime frameDescription
Length of hospital stayestimated average length of hospital stay of 5 - 7 daysThe number of days the patient is in hospital following surgery
Unplanned admission to critical care.Participants will be followed for the duration of hospital stay, an expected average of 5 - 7 daysWe are looking at admission to critical care that was not arranged pre-operatively - a certain proportion of patients are routinely admitted to critical care because of medical co-morbidities. We are looking for those patients who were deemed fit enough not to need critical care post-operatively who subsequently need admission there, and the length of their stay there.
Returns to the operating theatreNumber of events during Hospital admission (estimated average length of hospital stay of 5 - 7 days)The number of times a patient has to be returned to the operating theatre during their index admission.
Hospital readmissionWithin 30 days of discharge from hospitalNumber of readmissions to hospital following discharge elated to the patients surgery
MortalityUp to 30 days following hospital dischargePatient mortality rate following surgery up to 30 days following discharge

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026