Microvascular monitoring during liver resection surgery - a pilot study

• Register: ISRCTN
• Last refreshed on: 20 February 2017
• Main ID: ISRCTN83180572
• Date of registration: 20/03/2015
• Prospective Registration: No
• Primary sponsor: Royal Surrey County Hospital NHS Foundation Trust
• Public title: Microvascular monitoring during liver resection surgery - a pilot study
• Scientific title: Microvascular monitoring during liver resection surgery - a pilot prospective observational cohort study
• Date of first enrolment: 01/12/2014
• Target sample size: 40
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN83180572
• Study type: Observational
• Study design: Prospective observational cohort study (Treatment)

Countries of recruitment

United Kingdom

Contacts

• Name: Ben Creagh-Brown

Key inclusion & exclusion criteria

Inclusion criteria: 1. At least 18 years of age
2. Elective (planned) liver resection surgery
3. Provides informed consent to participate in surgery
Exclusion criteria: 1. Glossectomy (previous surgery to remove part or all of the tongue)
2. Glossitis (inflammation of the tongue)
3. Lack of mental capacity

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Liver surgery, microcirculatory monitoring
Surgery

Intervention(s)

Patients enrolled into the study will have imaging of the blood flow in the small blood vessels in their tongue. This will be measured by placing a camera underneath the tongue, similar to positioning a thermometer under the tongue to measure temperature. It will take approximately 10-15 minutes to position the camera and obtain the images. Images will be recorded before surgery, after you have been put to sleep but before the operation has started, during surgery when the liver is first exposed, at the time they have finished removing part of the liver, when you first arrive at intensive care, and later on in intensive care after you have received some fluids through a drip. We anticipate this to take a total of 60 to 90 minutes where the camera is in place. Half of these measurements (30-45 minutes divided into three separate 10-15 minute episodes) will be taken whilst you are awake and the rest you will be unaware of as you will be asleep during your surgery. In addition to this two measurements will be taken of blood flow in the small blood vessels of the liver, both of which you will be unaware of as you will be asleep. All patient data will be anonymised and entered onto a secure patient database.

Primary Outcome(s)

The primary analysis will compare the proportion of perfused vessels (PPV, %) for small (<20 µm) vessels at two time points: A (pre-anaesthetic); and during the liver resection surgery when the patient is maximally 'dessicated' (time B) using paired T-test or Wilcoxon non-parametric method if assumptions of normality are not met. Two-sided (5%) alpha level will be used to assess significant difference.

Secondary Outcome(s)

1. Another analysis will compare the paired PPV at times A and C (pre-anaesthetic and after GDFT, respectively) using the same paired T-test or Wilcoxon non-parametric method
2. The patients' PPV at all time (A, B and C) points will be compared between groups (with and without complications; with less than, or greater than, the median peak lactate in the first 24 hours; does/does not require vasoactive therapy for greater than 24 hours on ICU) using two-way repeated measures ANOVA for each variable separately or appropriate non-parametric method. Post hoc test will use Bonferroni method to adjust for multiple testing
3. To assess the relationship between automated Microscan measurements from sublingual and hepatic measurements taken during the intra-operative period Pearson's correlation coefficient or Spearman's rank correlation will be used as appropriate

Secondary ID(s)

N/A

Source(s) of Monetary Support

Surrey Peri-operative Anaesthetic Critical care collaboraive Research group (SPACeR)