Condition category
Cancer
Date applied
11/11/2010
Date assigned
07/03/2011
Last edited
02/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.bradfordresearch.nhs.uk/index.php

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

Publication citations

Additional files

Editorial Notes

02/03/2016: No publications found, verifying study status with principal investigator