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

ISRCTN	ISRCTN86457179
DOI	https://doi.org/10.1186/ISRCTN86457179
Secondary identifying numbers	8

Submission date: 11/11/2010
Registration date: 07/03/2011
Last edited: 10/05/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

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

Dr James McCaul
Scientific

Maxillofacial Unit
Horton Wing
St Luke's Hospital
Little Horton Lane
Bradford
BD5 0NA
United Kingdom

Phone	+44 (0)7801 350 191
Email	jim.mccaul@btinternet.com

Study information

Study design	Randomised controlled pilot study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The use of LiDCORapid for fluid optimisation in patients undergoing major head and neck cancer surgery: a randomised controlled pilot study
Study acronym	LiDCORapid
Study objectives	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(s)	Leeds (Central) Research Ethics Committee, 02/08/2010, ref: 10/H1313/4
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/09/2010
Completion date	31/08/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Target sample size is 82 patients (41 in each arm)
Key inclusion criteria	Any patient (aged over 18 years, either sex) undergoing major head and neck cancer surgery with free tissue transfer reconstruction
Key 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
Date of first enrolment	01/09/2010
Date of final enrolment	31/08/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

St Luke's Hospital

Bradford
BD5 0NA
United Kingdom

Sponsor information

Bradford Teaching Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Research and Development Department
Bradford Institute for Health Research
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
England
United Kingdom

Phone	+44 (0)1274 382 575
Email	john.wright@bradfordhospitals.nhs.uk
Website	http://www.bradfordresearch.nhs.uk/index.php
"ROR"	https://ror.org/05gekvn04

Funders

Funder type

Government

Bradford Teaching Hospitals NHS Foundation Trust (UK)

No information available

National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme application pending as of 11/11/2010

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration 1. 2011 conference proceedings in https://doi.org/10.1016/j.bjoms.2012.04.201 2. 2012 conference proceedings in https://doi.org/10.1016/j.bjoms.2012.04.201
IPD sharing plan

Editorial Notes

10/05/2018: Conference proceedings added to publication and dissemination plan.
02/03/2016: No publications found, verifying study status with principal investigator