Contact information
Type
Scientific
Primary contact
Miss Khadra Galaal
ORCID ID
Contact details
Northern Gynaecological Oncology Centre
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
+44 (0)191 445 2597
khadra.galaal@ghnt.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effect of intra-operative fluid optimisation using the oesophageal Doppler monitor in gynaecological oncology surgery
Acronym
Study hypothesis
Goal directed optimisation of intra-operative haemodynamics using oesophageal Doppler monitoring reduces length of hospital stay and improves outcome.
Ethics approval
Not provided at time of registration
Study design
Single-centre interventional prospective double-blinded randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/11/2010
Overall trial end date
01/05/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
70 patients in each group (140 in total)
Participant 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
Recruitment start date
01/11/2010
Recruitment end date
01/05/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen Elizabeth Hospital
Gateshead
NE9 6SX
United Kingdom
Sponsor information
Organisation
Gateshead Health NHS Foundation Trust (UK)
Sponsor details
c/o Mrs Alison Harvey
Research and Development
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
+44 (0)191 445 2155
alison.harvey@ghnt.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Northern Gynaecological Oncology Centre (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Results - basic reporting
Publication summary