The Cost in Oxygen of Surgical Trauma

Post-operative Complications Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02238561
• Other study ID #: 14/P/123
• Status: Completed
• Phase: N/A
• First received: September 9, 2014
• Last updated: October 29, 2015
• Start date: November 2014
• Est. completion date: August 2015

Study information

• Verified date: February 2015
• Source: Plymouth Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Oxygen Consumption (V?O2)
• Oxygen Delivery (DO2)
• Post-operative Complications
• Postoperative Complications

Locations

Country	Name	City	State
United Kingdom	Plymouth Hospitals NHS Trust	Plymouth	Devon

Sponsors (1)

Lead Sponsor	Collaborator
Plymouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative morbidity score (POMS)	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.	Day 5 post surgery	Yes
Secondary	Length of hospital stay	The number of days the patient is in hospital following surgery	estimated average length of hospital stay of 5 - 7 days	Yes
Secondary	Unplanned admission to critical care.	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.	Participants will be followed for the duration of hospital stay, an expected average of 5 - 7 days	Yes
Secondary	Returns to the operating theatre	The number of times a patient has to be returned to the operating theatre during their index admission.	Number of events during Hospital admission (estimated average length of hospital stay of 5 - 7 days)	Yes
Secondary	Hospital readmission	Number of readmissions to hospital following discharge elated to the patients surgery	Within 30 days of discharge from hospital	Yes
Secondary	Mortality	Patient mortality rate following surgery up to 30 days following discharge	Up to 30 days following hospital discharge	Yes