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 |
| Protocol serial number | N/A |
| Sponsor | Gateshead Health NHS Foundation Trust (UK) |
| Funder | Northern Gynaecological Oncology Centre (UK) |
- 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
Scientific
Northern Gynaecological Oncology Centre
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
| Phone | +44 (0)191 445 2597 |
|---|---|
| khadra.galaal@ghnt.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre interventional prospective double-blinded randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
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. |
| Key secondary outcome measure(s) |
To evaluate the effect of target driven intra-operative fluid management using oesophageal Doppler on hospital stay, measured on day of discharge. |
| Completion date | 01/05/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 140 |
| 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
- United Kingdom
- England
Study participating centre
Queen Elizabeth Hospital
Gateshead
NE9 6SX
United Kingdom
NE9 6SX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/10/2017: No publications found in PubMed, verifying study status with principal investigator.
