The Cost in Oxygen of Surgical Trauma

Completed

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

• Registration Number: NCT02238561
• Lead Sponsor: University Hospital Plymouth NHS Trust

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.

Study Timeline

• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-11
• Study First Posted: 2014-09-12
• Study Start: 2014-11
• Status Verified: 2015-02
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-10-29
• Last Update Posted: 2015-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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%.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
postoperative morbidity score (POMS)	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 Outcome Measures

Name	Time	Method
Length of hospital stay	estimated average length of hospital stay of 5 - 7 days	The 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 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.
Returns to the operating theatre	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.
Hospital readmission	Within 30 days of discharge from hospital	Number of readmissions to hospital following discharge elated to the patients surgery
Mortality	Up to 30 days following hospital discharge	Patient mortality rate following surgery up to 30 days following discharge

Trial Locations

Locations (1)

Plymouth Hospitals NHS Trust; 🇬🇧 Plymouth, Devon, United Kingdom