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ISRCTN
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ISRCTN35322992
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ClinicalTrials.gov identifier
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Public title
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The effect of 'goal directed' fluid management during gynaecological oncology surgery using the oesophageal Doppler probe
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Scientific title
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The effect of intra-operative fluid optimisation using the oesophageal Doppler monitor in gynaecological oncology surgery
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Goal directed optimisation of intra-operative haemodynamics using oesophageal Doppler monitoring reduces length of hospital stay and improves outcome.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Single centre interventional prospective double blinded randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Gynaecological oncology surgery
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/11/2010
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Anticipated end date
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01/05/2012
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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70 patients in each group (140 in total)
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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To evaluate the effect of target driven intra-operative fluid management using oesophageal Doppler on hospital stay, measured on day of discharge.
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Sources of funding
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Northern Gynaecological Oncology Centre (UK)
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Trial website
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Publications
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Contact name
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Miss
Khadra
Galaal
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Address
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Northern Gynaecological Oncology Centre
Queen Elizabeth Hospital
Sheriff Hill
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City/town
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Gateshead
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Zip/Postcode
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NE9 6SX
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Country
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United Kingdom
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Tel
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+44 (0)191 445 2597
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Fax
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+44 (0)191 445 6192
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Email
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khadra.galaal@ghnt.nhs.uk
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Sponsor
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Gateshead Health NHS Foundation Trust (UK)
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Address
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c/o Mrs Alison Harvey
Research and Development
Queen Elizabeth Hospital
Sheriff Hill
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City/town
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Gateshead
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Zip/Postcode
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NE9 6SX
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Country
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United Kingdom
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Tel
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+44 (0)191 445 2155
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Email
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alison.harvey@ghnt.nhs.uk
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Sponsor website:
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http://www.gatesheadhealth.nhs.uk/index.php
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Date applied
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23/05/2010
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Last edited
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04/08/2010
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Date ISRCTN assigned
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04/08/2010
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