Effect of Prone Position on Liver Blood Flow and Function

NCT01781260 | Unknown

• 1 other identifier: 12098
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Recent occurrence of significant post-operative liver impairment at Nottingham University Hospitals NHS Trust has prompted investigation into whether interaction between general anaesthesia and prone positioning (lying face down) for surgery can influence liver function. Historical research has shown that the heart does not function as efficiently when an anaesthetised patient is placed in the prone position for surgery. The techniques used for anaesthetising and monitoring these patients have changed remarkably, since these studies were first performed. It is important to know accurately how the heart functions to enable better understanding of the changes in blood flow to the liver when in the prone position. Studies looking at blood flow to the liver when lying face down have been done before but are mainly reporting patients on the intensive care unit. These intensive care patients are different to those in theatre undergoing routine surgery. The intensive care patients are usually received in different types of drugs and monitored with several different types of monitor at the time. Perhaps most importantly is that they are placed face down on a soft air cushioned mattress and pillows rather than the rigid support used for surgical patients. This study will look at whether the function of the liver changes when a patient is anaesthetised and is then rolled onto their front. The function of the liver will be measured by looking how it clears a specific drug from the blood. Also this study will look at how accurate a particular type of heart monitor is when an anaesthetised patient is placed onto their front.

Conditions

Prone Position; Cardiac Output; Liver Circulation

Keywords

Prone position; Cardiac output; Liver Circulation

Outcome Measures

Primary Outcomes (1)

• Liver blood flow and function as measured by non-invasive determination of ICG excretion.

  To test the null hypothesis that hepatic blood flow or global hepatic function does not change in the prone position during anaesthesia and therefore the ICG elimination rate remains constant and is unaffected by anaesthesia or patient position.

  During operative anaesthesia on day 1

Secondary Outcomes (3)

• Validating LiDCO calibration between supine and prone positions

  During operative anaesthesia on day 1 of study

• Evaluation of change in cardiac output on position change.

  During surgical anaesthesia on day 1 of study

• Validation of preload predictors in the prone position.

  During surgical anaesthesia on day 1 of study

Study Arms (1)

Young. Fit. Minor neurosurgical operation. Prone position.

18-65 year old patients, without serious medical co-morbidities (assessed as ASA I/II status) who are having minor to moderate severity neurosurgical operations in the prone position.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients between the age of 18-65, presenting for neurosurgical procedures to the Queen's Medical Centre, Nottingham, England, UK.

You may qualify if:

• Adult patient
• ASA (American Society of Anaesthesiologists) I/II
• Surgery in prone position
• Classification of surgery as minor / moderate severity

You may not qualify if:

• Unable to speak or read English
• Age less than 18 years
• Age over 65 years
• Pregnancy
• Pre-existing hepatic dysfunction
• Taking oral lithium (interferes with LiDCOplus calibration factor)
• Severe valvular heart disease (reduced reliability of LiDCO measurements)
• Major severity surgery with predicted large blood loss or alteration in aortic root anatomy
• Intolerance including allergy to lithium, iodine or ICG
• Thyrotoxicosis
• Patients expected to require radio active iodine studies within one week of the study

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Queen's Medical Centre Campus, Nottingham University Hospitals NHS Trust.

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

RECRUITING

Central Study Contacts

Iain Moppett, MB BChir MA MRCP FRCA DM

CONTACT

+44 (0) 115 8231009; iain.moppett@nottingham.ac.uk

Marc Chikhani, BMedSci BMBS FRCA

CONTACT

+44 (0) 115 8231001; marc.chikhani@nottingham.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: January 31, 2013
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 2, 2015

Record last verified: 2015-12

Locations

GB (1)