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| [ ...Back to search results ] | [ Print-friendly version ] |
| The use of the LiDCORapid monitor to help guide how much fluids to give patients undergoing major head and neck cancer surgery |
| ISRCTN | ISRCTN86457179 |
| ClinicalTrials.gov identifier | |
| Public title | The use of the LiDCORapid monitor to help guide how much fluids to give patients undergoing major head and neck cancer surgery |
| Scientific title | The use of LiDCORapid for fluid optimisation in patients undergoing major head and neck cancer surgery: a randomised controlled pilot study |
| Acronym | LiDCORapid |
| Serial number at source | 8 |
| Study hypothesis |
Does the use of LiDCORapid intra-operative optimisation influence the time to declaration of medically fit for discharge from hospital following major head and neck cancer surgery?
The null hypothesis is that fluid optimisation using LiDCORapid has no influence on outcomes after major head and neck cancer surgery. |
| Lay summary | Lay summary under review with external organisation |
| Ethics approval | Leeds (Central) Research Ethics Committee approved on the 2nd August 2010 (ref: 10/H1313/4) |
| Study design | Randomised controlled pilot study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Head and neck cancer |
| Participants - inclusion criteria | Any patient (aged over 18 years, either sex) undergoing major head and neck cancer surgery with free tissue transfer reconstruction |
| Participants - exclusion criteria |
1. Patients declining to join the study
2. Patients with an arrhythmia that precludes the use of stroke volume variation (SVV), e.g., atrial fibrillation or significant sinus arrhythmia |
| Anticipated start date | 01/09/2010 |
| Anticipated end date | 31/08/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | Target sample size is 82 patients (41 in each arm) |
| Interventions |
Control group:
Patients allocated to traditional fluid management. Tidal ventilation will be set at 8 ml/kg. Maintenance crystalloid will be administered as compound sodium lactate (Hartmanns) at a rate of 1.5 ml/kg/hr. Fluid boli (initially volulyte 6% upto 50 m/kg then a gelatin based colloid thereafter and blood products where indicated) will be administered according to standard management whereby fluid is given guided by a combination of core-peripheral temperature difference and a urine output (aiming to achieve greater than 0.5 ml/kg/hr. Other factors that influence fluid administration will be determined by a combination of heart rate, blood pressure, central venous pressure (CVP), urine output, estimated evaporative fluid loss/blood loss and serial haemoglobin measurements. As a measure of end organ perfusion we will aim to achieve a minimum urine output of 0.5 ml/kg/hour. The LiDCORapid monitor will be obscured from the surgeons view behind the anaesthetic machine and will face away from the surgical team. The screen of the LiDCORapid monitor will be covered. During control cases the anaesthetic team will intermittently go to the monitor but will not raise the cover (therefore the anaesthetist will remain blinded to the information provided by the LiDCORapid machine). An independent research nurse will collect the data from the monitor at the end of each case. LiDCORapid intervention group: Patients allocated to LiDCORapid guided fluid management. Ventilation will be set at 8 ml/kg. Maintenance crystalloid will be administered as compound sodium lactate (Hartmanns) at a rate of 1.5 ml/kg/hr. Fluid administration by the anaesthetist will be guided by the LiDCORapid monitor. Fluid boli (initially volulyte 6% upto 50 m/kg then a gelatin based colloid thereafter and blood products where indicated) will be administered. A fluid bolus of 3 ml/kg will be given when the SVV exhibits a consistent rise above 10%. During cases using the LiDCORapid monitor the anaesthetic team will behave in the same manner as per the control group regarding viewing the LiDCORapid machine. The surgical team who look after the patient post-operatively will be blinded to the study group to which each patient belongs. At any point where clinical acumen suggests that fluid is necessary despite conflicting information from the monitor this will be given. Duration of LiDCORapid guided fluid management: Approximately 11 hours (during major head and neck surgery). Each participant is expected to be in the study from giving consent to when they are discharged from hospital, a total period of approximately 10 days. |
| Primary outcome measure(s) | Time to being declared medically fit for discharge (in hours from end of operation) |
| Secondary outcome measure(s) |
1. Length of stay in intensive treatment unit (ITU) (total time in ICU including note of readmission if occurs)
2. Total number of days in hospital 3. Readmissions within 30 days of surgery 4. Free tissue transfer complications 5. Return to theatre rate 6. Infective complications and their duration 7. Inpatient mortality Process outcome measures: 8. Difference in stroke volume and cardiac output between control and intervention groups at the beginning and end of the operation 9. Total volume of fluid given intra-operatively, colloid and crystalloid 10. Blood transfusion requirements (transfusion threshold of less than 8 g/dl unless patient has ischaemic heart disease in which case we would aim to keep Hb 9 - 11 g/dl per usual clinical practice |
| Sources of funding |
1. Bradford Teaching Hospitals NHS Foundation Trust (UK)
2. National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme application pending as of 11/11/2010 |
| Trial website | |
| Publications | |
| Contact name | Dr James McCaul |
| Address |
Maxillofacial Unit
Horton Wing St Luke's Hospital Little Horton Lane |
| City/town | Bradford |
| Zip/Postcode | BD5 0NA |
| Country | United Kingdom |
| Tel | +44 (0)7801 350 191 |
| jim.mccaul@btinternet.com | |
| Sponsor | Bradford Teaching Hospitals NHS Foundation Trust (UK) |
| Address |
Research and Development Department
Bradford Institute for Health Research Bradford Royal Infirmary Duckworth Lane |
| City/town | Bradford |
| Zip/Postcode | BD9 6RJ |
| Country | United Kingdom |
| Tel | +44 (0)1274 382 575 |
| Fax | +44 (0)1274 382 640 |
| john.wright@bradfordhospitals.nhs.uk | |
| Sponsor website: | http://www.bradfordresearch.nhs.uk/index.php |
| Date applied | 11/11/2010 |
| Last edited | 01/05/2012 |
| Date ISRCTN assigned | 07/03/2011 |
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