Plain English Summary
Background and study aims
Cardiac output is the volume of blood pumped by the heart per minute. Monitoring the cardiac output to guide fluid administration has been shown to benefit patients undergoing major colorectal surgery, improving their outcomes and reducing the length of hospital stay. The aim of this study is to detect any differences in patient outcome with the use of the LiDCOrapid monitor compared with conventional oesophageal Doppler monitoring.
Who can participate?
Patients undergoing elective colorectal surgery.
What does the study involve?
Both monitors are set up and the participant is randomly allocated to have their fluid administration guided by either LiDCOrapid or oesophageal Doppler. The anaesthetist is not able to see the measurements from the other monitor, but paired measurements are taken throughout. Patient outcomes are collected during their hospital stay and follow-up.
What are the possible benefits and risks of participating?
There is established evidence behind the use of both LiDCO and oesophageal Doppler monitoring and both are already in widespread use. An interim analysis will take place once half of the participants have been recruited to avoid harm if significant differences in outcome are detected.
Where is the study run from?
St Thomas' Hospital (UK)
When is the study starting and how long is it expected to run for?
May 2011 to October 2013
Who is funding the study?
Guy's and St Thomas' Charity (UK)
Who are the main contacts?
Mr Jonathan van Dellen (Research Fellow) - email@example.com
Mr Andrew Williams (Consultant Colorectal Surgeon)
Dr Stuart McCorkell (Consultant Anaesthesist)
Comparison of goal-directed fluid optimisation guided by LiDCOrapid and conventional oesophageal Doppler effect on intra-operative oxygen delivery index and post-operative outcomes: a randomised control non-inferiority study
Intra-operative goal-directed fluid optimisation guided by LiDCOrapid achieves non-inferior oxygen delivery index optimisation and equivalent patient outcomes compared to oesophageal Doppler monitoring.
NRES Committee London - Westminster, ref: 11/H0802/9
Single-centre prospective double-blinded (patient & assessor) randomised non-inferiority trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Improving perioperative care for elective colorectal surgery
Anaesthetist randomised to use either:
1. LiDCOrapid in intervention group OR
2. Conventional oesophageal Doppler cardiac output monitoring in control arm to guide goal-directed fluid therapy
Both monitors will be attached intraoperatively to allow paired readings. The anaesthetist will be blinded to the measurements of other monitor not being used.
Primary outcome measure
Post-operative length of stay (in days)
Secondary outcome measures
1. Intra-operative oxygen delivery index values
2. Intra-operative intravenous fluid volumes
3. Intra-operative differences in % change stroke volume
5. Functional recovery (mobility and return of gastrointestinal function)
6. In-hospital and 30-day mortality
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Elective or semi-elective patients due to undergo colorectal surgery as part of Enhanced Recovery Protocol
2. Successful simultaneous LiDCOrapid and oesophageal Doppler monitoring throughout surgery
Target number of participants
Participant exclusion criteria
1. Emergency surgery
2. Lack of capacity to consent
4. All excluded patients from patient groups to be reported in results
5. Contraindications to oesophageal Doppler probe
5.1. nasal injuries or polyps
5.2. severe oesophageal/laryngeal/pharyngeal disease
5.3. recent oesophageal/laryngeal/pharyngeal surgery
5.4. thoracic aortic aneurysm
5.5. severe bleeding diathesis
5.6. long-term systemic steroid therapy
5.7. portal hypertension
6. Contraindications to arterial line or LiDCOrapid
6.1. weight <40kg
6.2. aortic valve regurgitation
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
St Thomas' Hospital
Guy's & St. Thomas' NHS Foundation Trust (UK)
c/o Karen Ignation
Guy's and St. Thomas' Charity (UK) ref: G100706
Funding Body Type
private sector organisation
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)