Post-op oesophageal Doppler trial: effect on clinical outcome of extension of oesophageal Doppler goal-directed fluid optimisation into the post-operative recovery period

ISRCTN	ISRCTN24020298
DOI	https://doi.org/10.1186/ISRCTN24020298
Secondary identifying numbers	RJ1 11/N160

Submission date: 12/07/2012
Registration date: 14/09/2012
Last edited: 18/05/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Mr Andrew Williams
Scientific

Department of Colorectal Surgery
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Dr Jonathan van Dellen
Scientific

N/A
London
N/A
United Kingdom

ORCID ID	0000-0002-1343-6140
Phone	N/A
Email	jvandellen@doctors.org.uk

Study information

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
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	ISRCTN24020298_PIS_Mar11.doc
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.
Study objectives	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(s)	NRES Committee London - Westminster, 06/04/2011, ref: 11/H0802/9
Health condition(s) or problem(s) studied	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
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 study start date	24/05/2011
Completion date	01/10/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	86
Key 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)
Key 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
Date of first enrolment	24/05/2011
Date of final enrolment	20/09/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

St Thomas' Hospital

London
SE1 7EH
United Kingdom

Sponsor information

Guy's & St Thomas' NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Karen Ignation
London
SE1 7EH
England
United Kingdom

Website	http://www.guysandstthomas.nhs.uk/
"ROR"	https://ror.org/00j161312

Funders

Funder type

Charity

Guy's and St. Thomas' Charity (UK) ref: G100706
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Guy's and St Thomas' Charity, Guy's and St Thomas' Foundation, GSTTFoundation
Location: United Kingdom

Results and Publications

Intention to publish date	31/12/2018
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet				No	Yes
Protocol file	version v1	14/10/2011		No	No

Editorial Notes

18/05/2018: The following changes have been made:
1. The recruitment end date has been changed from 01/10/2012 to 20/09/2012.
2. An intention to publish date has been added.
3. Uploaded protocol Version 1.2.1 14 October 2017 (not peer-reviewed)
4. The patient information sheet has been uploaded.
5. An IPD sharing statement has been added.
24/01/2018: No publications found in PubMed, verifying study status with principal investigator.