Contact information
Type
Scientific
Primary contact
Dr James McCaul
ORCID ID
Contact details
Maxillofacial Unit
Horton Wing
St Luke's Hospital
Little Horton Lane
Bradford
BD5 0NA
United Kingdom
+44 (0)7801 350 191
jim.mccaul@btinternet.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
8
Study information
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
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.
Ethics approval
Leeds (Central) Research Ethics Committee, 02/08/2010, ref: 10/H1313/4
Study design
Randomised controlled pilot study
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
Head and neck cancer
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Time to being declared medically fit for discharge (in hours from end of operation)
Secondary outcome measures
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
Overall trial start date
01/09/2010
Overall trial end date
31/08/2012
Reason abandoned
Eligibility
Participant inclusion criteria
Any patient (aged over 18 years, either sex) undergoing major head and neck cancer surgery with free tissue transfer reconstruction
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Target sample size is 82 patients (41 in each arm)
Participant 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
Recruitment start date
01/09/2010
Recruitment end date
31/08/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Luke's Hospital
Bradford
BD5 0NA
United Kingdom
Sponsor information
Organisation
Bradford Teaching Hospitals NHS Foundation Trust (UK)
Sponsor details
Research and Development Department
Bradford Institute for Health Research
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
+44 (0)1274 382 575
john.wright@bradfordhospitals.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Bradford Teaching Hospitals NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme application pending as of 11/11/2010
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