The effect of 'goal directed' fluid management during gynaecological oncology surgery using the oesophageal Doppler probe

ISRCTN	ISRCTN35322992
DOI	https://doi.org/10.1186/ISRCTN35322992
Secondary identifying numbers	N/A

Submission date: 23/05/2010
Registration date: 04/08/2010
Last edited: 04/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Khadra Galaal
Scientific

Northern Gynaecological Oncology Centre
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom

Phone	+44 (0)191 445 2597
Email	khadra.galaal@ghnt.nhs.uk

Study information

Study design	Single-centre interventional prospective double-blinded randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The effect of intra-operative fluid optimisation using the oesophageal Doppler monitor in gynaecological oncology surgery
Study objectives	Goal directed optimisation of intra-operative haemodynamics using oesophageal Doppler monitoring reduces length of hospital stay and improves outcome.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Gynaecological oncology surgery
Intervention	Two groups: control and protocol group. Both groups will have DP6 Doppler probe (product code 9070-7001) inserted at the time of intubation. All patients will have standard pre-operative, intra-operative and post-operative care. Fluids (crystalloid, colloid and blood/blood products) will be given at the discretion of the anaesthetist, guided by standard haemodynamic monitoring and operative losses. Only the protocol group will have direct measurement of central vascular flow using CardioQ-ODM monitor (product code 9051-7056) including corrected flow time (FTc), stroke volume (SV), stroke distance (SD) and peak velocity (PV) and small colloid (fluid) challenges to maintain FTc greater than 0.35 seconds and optimise SV. The intervention will last until the end of the operation and the probe will be removed at the time of extubation.
Intervention type	Procedure/Surgery
Primary outcome measure	The aim of this study is to compare the effect of a target driven intra-operative intravenous fluid management using oesophageal Doppler to a standard fluid regimen on complication rate after surgery for corpus uteri, ovarian and cervical cancer. Measured until 5th post-operative day.
Secondary outcome measures	To evaluate the effect of target driven intra-operative fluid management using oesophageal Doppler on hospital stay, measured on day of discharge.
Overall study start date	01/11/2010
Completion date	01/05/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	70 patients in each group (140 in total)
Key inclusion criteria	1. Patients aged 20 - 85 years, female 2. Recruited from the Queen Elizabeth Hospital, Gateshead 3. Written informed consent 4. Undergoing elective major gynaecological oncology surgery for ovarian, endometrial and cervical carcinoma
Key exclusion criteria	Contraindication to oesophageal Doppler use: 1. Oesophageal surgery or stent 2. Oesophageal stricture 3. Oesophageal varices 4. Pharyngeal pouch 5. Moderate/severe aortic valve disease 6. Patient refusal
Date of first enrolment	01/11/2010
Date of final enrolment	01/05/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Queen Elizabeth Hospital

Gateshead
NE9 6SX
United Kingdom

Sponsor information

Gateshead Health NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Mrs Alison Harvey
Research and Development
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
England
United Kingdom

Phone	+44 (0)191 445 2155
Email	alison.harvey@ghnt.nhs.uk
Website	http://www.gatesheadhealth.nhs.uk/index.php
"ROR"	https://ror.org/01aye5y64

Funders

Funder type

Hospital/treatment centre

Northern Gynaecological Oncology Centre (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

04/10/2017: No publications found in PubMed, verifying study status with principal investigator.