The use of the LiDCORapid monitor to help guide how much fluids to give patients undergoing major head and neck cancer surgery

• Register: ISRCTN
• Last refreshed on: 11 June 2018
• Main ID: ISRCTN86457179
• Date of registration: 07/03/2011
• Prospective Registration: No
• Primary sponsor: Bradford Teaching Hospitals NHS Foundation Trust (UK)
• 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
• Date of first enrolment: 01/09/2010
• Target sample size: 82
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN86457179
• Study type: Interventional
• Study design: Randomised controlled pilot study (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: James McCaul

Key inclusion & exclusion criteria

Inclusion criteria: Any patient (aged over 18 years, either sex) undergoing major head and neck cancer surgery with free tissue transfer reconstruction
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Head and neck cancer
Cancer
Head and neck cancer

Intervention(s)

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 an

Primary Outcome(s)

Time to being declared medically fit for discharge (in hours from end of operation)

Secondary Outcome(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

Source(s) of Monetary Support

Bradford Teaching Hospitals NHS Foundation Trust (UK), National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme application pending as of 11/11/2010

Ethics review

Status:
Approval date:
Contact:

Leeds (Central) Research Ethics Committee, 02/08/2010, ref: 10/H1313/4

Results

• Results available: Yes
• Date Completed: 31/08/2012