Cardiac Output Monitoring and Pre-operative Exercise Testing for Colorectal surgery

Completed

• Conditions: Elective major colorectal surgery; Surgery

• Registration Number: ISRCTN14680495
• Lead Sponsor: Plymouth Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

1. Both males and females, age 18 and older
2. Elective colorectal surgical patients scheduled for major surgery
3. Patients with a measurable anaerobic threshold (AT) above 8 ml O2/kg/min

Exclusion Criteria

Absolute:
1. Unwillingness to participate
2. Inability to perform the tests and consent within the timetable for elective surgery
3. Measured Anaerobic Threshold below 8 ml O2/kg/min. Such patients will be considered to be extremely unfit and as such will not be suitable for inclusion in the trial.
4. Withdrawn by anaesthetist or surgeon
5. Acute myocardial infarction (3?5 days)
6. Unstable angina
7. Uncontrolled arrhythmias causing symptoms or haemodynamic compromise
8. Syncope
9. Active endocarditis
10. Acute myocarditis or pericarditis
11. Symptomatic severe aortic stenosis
12. Uncontrolled heart failure
13. Acute pulmonary embolus or pulmonary infarction
14. Thrombosis of lower extremities
15. Suspected dissecting aneurysm
16. Uncontrolled asthma
17. Pulmonary edema
18. Room air desaturation at rest <85%
19. Respiratory failure
20. Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis)
21. Severe oesophageal disease
22. Recent oesophageal or upper airway surgery
23. Systemic steroid medication
24. Bleeding diathesis

Relative:
25. Left main coronary stenosis or its equivalent
26. Moderate stenotic valvular heart disease
27. Severe untreated arterial hypertension at rest (200 mm Hg systolic, 120 mm Hg diastolic)
28. Tachyarrhythmias or bradyarrhythmias
29. High-degree atrioventricular block
30. Hypertrophic cardiomyopathy
31. Significant pulmonary hypertension
32. Advanced or complicated pregnancy
33. Electrolyte abnormalities
34. Orthopaedic impairment that compromises exercise performance

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amongst patients having major elective colorectal surgery under an Enhanced Recovery after Surgery (ERAS) pathway:<br>1.Does intraoperative goal directed fluid therapy decrease postoperative hospital length of stay when compared with standard therapy alone in patients who are categorised ?high risk? on the basis of a preoperative cardiopulmonary exercise test result?<br>2.Does intraoperative goal directed fluid therapy decrease postoperative hospital length of stay when compared with standard therapy alone in patients who are categorised ?standard risk? on the basis of a preoperative cardiopulmonary exercise test result?<br>3.Does intraoperative goal directed fluid therapy decrease postoperative hospital length of stay when compared with standard therapy alone in all patients?<br>

Secondary Outcome Measures

Name	Time	Method
Amongst patients having major elective colorectal surgery under an ERAS pathway, does intraoperative goal directed fluid therapy make a difference to the following when compared with standard therapy alone?: <br>1. Peri-operative mortality (30 days) <br>2. Postoperative hypotension<br>3. Postoperative fluid requirement<br>4. Return of gastrointestinal function <br>5. Tolerance of diet<br> <br>Secondary outcomes 2-5 will be assessed every post-op day until the participants meet discharge criteria (median length of stay for this surgery is currently 9 days [as of 17/02/2009]).