Blood oxygen carrying capacity, iron, CPET and POMS - a pilot study
Research type
Research Study
Full title
Blood oxygen carrying capacity, iron status and cardiopulmonary exercise testing in patients awaiting major surgery, and their relationship to postoperative morbidity: a pilot study
IRAS ID
131241
Contact name
Toby Richards
Contact email
Sponsor organisation
University College London Hospital / University College London
Research summary
Research question/aim?
This research aims to characterise haematological parameters, iron status, blood oxygen carrying capacity and exercise capacity (determined by cardiopulmonary exercise testing [CPET]) in surgical patients, and to determine their relationships with one another and with surgical outcome.
How is it of relevance and importance to patients and public?
Approximately 3 million surgical operations a year are conducted in the UK. Gaining a greater understanding of the clinical factors that may influence patient outcome after surgery is important as this allows strategies to be developed and implemented that aim to reduce the incidence of death and complications (morbidity), both of which remain a major public health issue.
Fitness levels before surgery are related to surgical outcome, with less fit patients at a greater risk of complications and death. One factor that influences fitness levels is the capacity of the blood to carry oxygen. Surgery, like exercise, places substantial metabolic demands upon the body that increases the requirement for oxygen. It is suggested that the ability to increase oxygen delivery to tissues is an important determinant of surgical outcome, with patients who are unable to meet these physical demands at a greater risk of complications. In this context and given the aims of this research, this project is of relevance to patients undergoing surgery and members of the public who may have surgery in the future.
This study will be prospective, observational and conducted as a pilot. In addition, these data will form part of a Graduate Research Degree (PhD) and so has an educational and training objective in addition to generating research data.
What area (disease, therapy or service) is being studied?
This research will study patients awaiting major surgery from a number of surgical specialties, including but not exclusively: colorectal, upper gastrointestinal, urological, vascular, head and neck, and hepatobiliary.
Who will be eligible?
Eligibility for inclusion in the study will be based on the criteria below:
i) male or female adults (>18 years)
ii) able to perform cardiopulmonary exercise testing (CPET)
iii) able to consent
iv) awaiting major surgeryWhere?
Patients will be targeted for recruitment into this study at the following NHS Trusts: i) University College London Hospitals NHS Foundation Trust, ii) Royal Free London NHS Foundation Trust, & iii) Whittington Health.
How long will the study last and what will the participants undergo?
The length of time participants are in the study will be dependent on individual total hospital length of stay (LOS). Approximately, patients will be enrolled in the study for between 2-4 weeks. Baseline patient data will be collected: including, but not exclusively, diagnosis, medical history, and medications. Patients recruited to the study will have the following samples collected during study enrollment: i) venous blood, and ii urine. In addition, patients will undergo the following tests during study enrollment; i) measurement of blood oxygen carrying capacity using the optimised carbon monoxide (CO) rebreathing method, ii) Cardiopulmonary exercise test (CPET). These tests will all be applied to recruited patients.
Data relating to the occurrence of postoperative morbidity [Postoperative Morbidity Survey (POMS)] will be collected after surgery by members of the UCL Surgical Outcomes Research Centre (SOURCE). POMS consists of 9 different areas of morbidity (pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, haematological, wound, and pain). For each of the 9 categories, the presence of absence of morbidity is recorded on the basis of objective criteria. POMS defines morbidity in terms of clinically important consequences and is a valid and reliable measure of postoperative morbidity.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
13/LO/1901
Date of REC Opinion
13 Mar 2014
REC opinion
Further Information Favourable Opinion