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NCT Number: NCT02238561

The Cost in Oxygen of Surgical Trauma

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)

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Plymouth Hospitals NHS Trust

Plymouth, Devon, PL6 8DH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

Primary outcomes

  1. postoperative morbidity score (POMS)

    Time frame: Day 5 post surgery

    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.

Secondary outcomes

  1. Length of hospital stay

    Time frame: estimated average length of hospital stay of 5 - 7 days

    The number of days the patient is in hospital following surgery

  2. Unplanned admission to critical care.

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

    We 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.

  3. Returns to the operating theatre

    Time frame: Number 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.

  4. Hospital readmission

    Time frame: Within 30 days of discharge from hospital

    Number of readmissions to hospital following discharge elated to the patients surgery

  5. Mortality

    Time frame: Up to 30 days following hospital discharge

    Patient mortality rate following surgery up to 30 days following discharge

Sponsors and collaborators

Lead sponsor

University Hospital Plymouth NHS Trust

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 12, 2014
Registry last updated
Oct 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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