Plain English Summary
Background and study aims
Cardiac output is the volume of blood pumped by the heart per minute. It can be measured by placing a probe into the oesophagus (food pipe) via the mouth or nose, a procedure called oesophageal Doppler monitoring. Guiding treatment with cardiac output monitoring has been shown to benefit patients undergoing major colorectal surgery, improving outcomes and reducing the length of hospital stay. Traditionally this monitoring has only been used during surgery. With the introduction of flexible probes, this monitoring can now be used in awake patients after surgery. The group most likely to benefit are high-risk patients. We aim to find out about the effect of continuing the use of this monitoring to guide treatment after surgery in high-risk colorectal surgery patients.
Who can participate?
High-risk patients aged 18 and over undergoing colorectal surgery.
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in one group undergo oesophageal Doppler cardiac output monitoring for 16 hours (overnight) after their operation. Participants in the other group receive standard care with the probe in place but not used for monitoring. We then compare the outcomes of the two groups during their hospital stay and at follow-up.
What are the possible benefits and risks of participating?
Oesophageal Doppler monitoring has already been tested in cardiac and trauma patients. Patients can request early removal of the probe before the end of the 16-hour monitoring period if they wish. Patients who may be at risk of nasal or oesophageal injury from the probe are excluded from the study.
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 2012
Who is funding the study?
Guy's and St. Thomas' Charity (UK).
Who is the main contact?
Mr Jonathan van Dellen
jvandellen@doctors.org.uk
Trial website
Contact information
Type
Scientific
Primary contact
Mr Andrew Williams
ORCID ID
Contact details
Department of Colorectal Surgery
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Type
Scientific
Additional contact
Dr Jonathan van Dellen
ORCID ID
http://orcid.org/0000-0002-1343-6140
Contact details
N/A
London
N/A
United Kingdom
N/A
jvandellen@doctors.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RJ1 11/N160
Study information
Scientific title
Effect on clinical outcome of extension of oesophageal Doppler goal-directed fluid optimisation into the post-operative recovery period: a randomised control trial.
Acronym
Study hypothesis
Extension of OD-guided goal-directed fluid optimisation into the immediate 16-hour post-operative period, in high risk colorectal ERP patients, achieves an oxygen delivery index ≥600ml/min/ m2 for the majority of the duration of this period, and subsequently improves patient outcomes.
Ethics approval
NRES Committee London - Westminster, 06/04/2011, ref: 11/H0802/9
Study design
Single-centre prospective single-blinded (assessor blinded to outcomes) randomised control study within an academic tertiary referral hospital setting
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
See additional files
Condition
Improving perioperative care for elective colorectal surgery within an Enhanced Recovery Programme
Intervention
Intervention group will have 16 hours post-operative oesophageal Doppler cardiac output monitoring with nurse-led stroke volume optimisation in an overnight intensive recovery (OIR) unit.
Control group will have an equivalent OIR admission without cardiac output monitoring (nasal oesophageal Doppler probe still in-situ for 16h measurements).
Follow-up of outcomes during hospital admission and standard telephone and outpatient clinic follow-up.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Post-operative length of stay (in days)
Secondary outcome measures
1. Oxygen delivery index at end of 16h post-operative recovery period
2. Mean oxygen delivery index over 16h post-operative recovery period
3. Morbidity
4. Functional recovery (mobility and return of gastrointestinal function)
5. In-hospital and 30-day mortality
Overall trial start date
24/05/2011
Overall trial end date
01/10/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Consecutive elective or semi-elective patients due to undergo colorectal surgery as part of Enhanced Recovery Protocol involving resection or anastamosis of bowel
2. High-risk participants will be defined as having (1) pre-operative ASA grade III+ OR anaerobic threshold <11 ml/min/kg on cardiopulmonary exercise testing OR undergoing major complex surgery (as per OPCS 4.5 classification - Office of Population, Censuses and Surveys Classification of Surgical Operations and Procedures)
3. Ages 18 and over (no upper limit)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
86
Participant exclusion criteria
1. Emergency surgery
2. Lack of capacity to consent
3. Pregnancy
4. Contraindications to oesophageal Doppler probe:
4.1. Nasal injuries or polyps
4.2. Severe oesophageal/laryngeal/pharyngeal disease
4.3. Recent oesophageal/laryngeal/pharyngeal surgery
4.4. Thoracic aortic aneurysm
4.5. Severe bleeding diathesis
4.6. Long-term systemic steroid therapy
4.7. Portal hypertension
All excluded patients from patient groups to be reported in results
Recruitment start date
24/05/2011
Recruitment end date
20/09/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Thomas' Hospital
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Guy's & St Thomas' NHS Foundation Trust (UK)
Sponsor details
c/o Karen Ignation
London
SE1 7EH
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Guy's and St. Thomas' Charity (UK) ref: G100706
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date. Current plans are for submission and storage with King’s College London Data Management system.
Intention to publish date
31/12/2018
Participant level data
Stored in repository
Basic results (scientific)
Publication list