Post-operative oxygen delivery in patients undergoing major non-cardiac surgery to reduce morbidity

ISRCTN	ISRCTN76894700
DOI	https://doi.org/10.1186/ISRCTN76894700
Protocol serial number	UK NIHR CSP 22346
Sponsor	University College London Hospitals NHS Trust (UK)
Funders	Academy of Medical Sciences/Health Foundation (UK) - Clinician Scientist award to Dr GL Ackland, University College London Hospitals NHS Trust/University College London (UK) - Comprehensive Biomedical Research Centre, University College London (UK) - Centre for Anaesthesia, Critical Care and Pain Medicine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Gareth Ackland
Scientific

Wolfson Institute for Biomedical Research
University College London
Gower Street
London
WC1E 6BT
United Kingdom

Email	g.ackland@ucl.ac.uk

Primary study design	Interventional
Study design	Two-centre randomised double-blind placebo-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Prospective randomised controlled trial of post-operative optimisation of oxygen delivery in patients undergoing major non-cardiac surgery to reduce morbidity
Study acronym	POM-O
Study objectives	Enhancing oxygen delivery to a pre-determined target immediately post-operatively reduces post-operative morbidity and length of hospital stay in high risk surgical patients.
Ethics approval(s)	Outer South East London REC - South London REC Office (4), 29/12/2009, ref: 09/H0805/58
Health condition(s) or problem(s) studied	Post-operative morbidity
Intervention	Patients randomised to undergo fluid with/without inotropic support (goal-directed therapy) to achieve pre-defined oxygen delivery target for 6 hours immediately post-operatively.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Reduction in post-operative morbidity on day 3 post-operatively as defined by the Post-Operative Morbidity Survey (POMS)
Key secondary outcome measure(s)	Measured pre-operatively and at 1, 2, 5 and 8 days post-operatively: 1. Immune, bioenergetic, microcirculatory and cellular correlates associated with development of post-operative morbidity 2. Length of hospital stay
Completion date	01/03/2013

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	204
Key inclusion criteria	Patients undergoing major elective major surgical procedures that are associated with a high incidence of post-operative morbidity (abdominal/oesophageal/hepatic resection/gynaecology/urological reconstructive surgery) and who meet the following criteria: 1. American Society of Anaesthesiologists risk grade 3 - 4 2. Aged greater than 50 years, either sex 3. Greater than two risk factors defined by the Revised Cardiac Risk Index
Key exclusion criteria	1. Concurrent lithium therapy (incompatible with cardiac output monitoring device) 2. Acute myocardial ischaemia (contraindication for inotropic support) 3. Acute arrhythmias (contraindication for inotropic support) 4. Pregnancy (lithium-based cardiac output monitoring device) 5. Patients receiving palliative treatment only
Date of first enrolment	01/03/2010
Date of final enrolment	01/03/2013

Wolfson Institute for Biomedical Research

London
WC1E 6BT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2015		Yes	No
Results article	sub-study results	05/07/2021	12/07/2021	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

12/07/2021: Publication reference added.