Prone PositionPLiFNCT01781260
Effect of Prone Position on Liver Blood Flow and Function
An observational study of Prone Position and Cardiac Output, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prone Position, Cardiac Output, Liver Circulation
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2014to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients between the age of 18-65, presenting for neurosurgical procedures to the Queen's Medical Centre, Nottingham, England, UK.
Who may be able to join
- Adult patient
- ASA (American Society of Anaesthesiologists) I/II
- Surgery in prone position
- Classification of surgery as minor / moderate severity
Who cannot join
- Inability to give consent to inclusion in trial
- Unable to speak or read English
- Age less than 18 years
- Age over 65 years
- Pregnancy
- Pre-existing hepatic dysfunction
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen's Medical Centre Campus, Nottingham University Hospitals NHS Trust.
Nottingham, Nottinghamshire, NG7 2UH
Marc Chikhani, BMedSci BMBS FRCA, +44 (0) 115 823 1001, marc.chikhani@nottingham.ac.uk
Marc Chikhani, BMedSci BMBS FRCA
About this study
Official title: The Effect of Prone Positioning During Anaesthesia on Liver Blood Flow and Function
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.
Read more
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.
Read the detailed description
Recent occurrence of significant post-operative hepatic dysfunction including two fatalities at Nottingham University Hospitals NHS Trust has prompted investigation into whether interaction between general anaesthesia, prone positioning for surgery, cardiac output and the use of vasoactive drugs can influence hepatic function.
Research has shown that cardiac output is decreased when an anaesthetised patient is placed from the supine to the prone position, and that the magnitude of these changes vary with the exact method of physical patient support in the prone position.1-3 Anaesthetic technique and methods of cardiac output monitoring used in these studies are no longer in routine use and therefore may not accurately reflect current practice of balanced anaesthesia or current monitoring techniques.
The LiDCOplus minimally invasive cardiac output monitor can be used to accurately calculate cardiac ouput and its associated derived variables (stroke volume and systemic vascular resistance). The LiDCOplus monitor uses data already available from an arterial cannula which is routinely used for monitoring patients in these circumstances. It is calibrated by using a small (0.3mmol) bolus dose of lithium chloride. This technique has been shown to be accurate and safe even after repeated calibration procedures over a short time period.4-6
Much of the evidence with regards to liver blood flow in the anaesthetised patient in prone position is from the critical care literature. There are several differences between this group of critically ill patients undergoing prone positioning for rescue therapy from refractory hypoxia due to acute lung injury and healthy patients undergoing elective surgery in the prone position. Critically ill patients have multiple cardiovascular and respiratory co-morbidities, are usually receiving infusions of vasoactive drugs and are generally positioned on soft air cushioned mattresses and pillows. Prone positioning in these patients does not seem to significantly alter hepatic function as measured by hepatic Indocyanine Green (ICG) clearance.7 8
ICG is a fluorescent dye, which can absorb infra-red light with a very rare (1:40 000) side effect profile. After intravenous injection it is almost exclusively eliminated by hepatic excretion into bile. The rate of hepatic elimination has been shown to correlate accurately with plasma disappearance rate as measured by transcutaneous infra-red absorbtion.9 It is a dynamic marker of hepatic blood flow, hepatocellular function and biliary excretion, with short term variation thought to be attributable to changes in hepatic blood flow rather than cellular dysfunction.10
The LiMON monitor uses transcutaneous infra-red light absorption (like a pulse oximeter) to measure and calculate values for ICG plasma disappearance and its associated values such as clearance rate and plasma retention rate. The technique involves intravenous injection of a small (0.25mg/kg) bolus dose of ICG. This can be repeated up to 20 times per 24hr period.
It is postulated that simultaneously measuring changes in hepatic blood flow and cardiac output will allow us to gather greater understanding of the haemodynamic changes associated with the prone position in the anaesthetised patient using current routine monitoring modalities.
- Conditions
- Prone Position, Cardiac Output, Liver Circulation
- Keywords
- Prone position, Cardiac output, Liver Circulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During operative anaesthesia on day 1
Secondary outcomes (3)
Validating LiDCO calibration between supine and prone positions
To test the null hypothesis that calibration factor for the LiDCOplus monitor as determined by lithium dilution is not affected by changing the patient from supine to prone position.
Measured: During operative anaesthesia on day 1 of study
Evaluation of change in cardiac output on position change.
To test the null hypothesis that cardiovascular parameters as measured by the LiDCOplus monitor are not affected by changing the patient from supine to prone position.
Measured: During surgical anaesthesia on day 1 of study
Validation of preload predictors in the prone position.
To test the null hypothesis that the dynamic indices of preload retain their discriminatory ability to predict positive response following a fluid bolus when the patient is placed in the prone position.
Measured: During surgical anaesthesia on day 1 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startMay 2014
- Primary completionMay 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prone PositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781260
- Sponsor's protocol ID
- 12098
- Acronym
- PLiF
- Status last verified
- Dec 2015
- First submitted
- 29 Jan 2013
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prone Positioning During Anaesthesia on Liver Blood Flow and Function
- ClinicalTrials.gov ID
- NCT01781260
- Acronym / sponsor ID
- PLiF / 12098
- Conditions
- Prone Position, Cardiac Output, Liver Circulation
- Keywords
- Prone position, Cardiac output, Liver Circulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Recent occurrence of significant post-operative hepatic dysfunction including two fatalities at Nottingham University Hospitals NHS Trust has prompted investigation into whether interaction between general anaesthesia, prone positioning for surgery, cardiac output and the use of vasoactive drugs can influence hepatic function.
Research has shown that cardiac output is decreased when an anaesthetised patient is placed from the supine to the prone position, and that the magnitude of these changes vary with the exact method of physical patient support in the prone position.1-3 Anaesthetic technique and methods of cardiac output monitoring used in these studies are no longer in routine use and therefore may not accurately reflect current practice of balanced anaesthesia or current monitoring techniques.
The LiDCOplus minimally invasive cardiac output monitor can be used to accurately calculate cardiac ouput and its associated derived variables (stroke volume and systemic vascular resistance). The LiDCOplus monitor uses data already available from an arterial cannula which is routinely used for monitoring patients in these circumstances. It is calibrated by using a small (0.3mmol) bolus dose of lithium chloride. This technique has been shown to be accurate and safe even after repeated calibration procedures over a short time period.4-6
Much of the evidence with regards to liver blood flow in the anaesthetised patient in prone position is from the critical care literature. There are several differences between this group of critically ill patients undergoing prone positioning for rescue therapy from refractory hypoxia due to acute lung injury and healthy patients undergoing elective surgery in the prone position. Critically ill patients have multiple cardiovascular and respiratory co-morbidities, are usually receiving infusions of vasoactive drugs and are generally positioned on soft air cushioned mattresses and pillows. Prone positioning in these patients does not seem to significantly alter hepatic function as measured by hepatic Indocyanine Green (ICG) clearance.7 8
ICG is a fluorescent dye, which can absorb infra-red light with a very rare (1:40 000) side effect profile. After intravenous injection it is almost exclusively eliminated by hepatic excretion into bile. The rate of hepatic elimination has been shown to correlate accurately with plasma disappearance rate as measured by transcutaneous infra-red absorbtion.9 It is a dynamic marker of hepatic blood flow, hepatocellular function and biliary excretion, with short term variation thought to be attributable to changes in hepatic blood flow rather than cellular dysfunction.10
The LiMON monitor uses transcutaneous infra-red light absorption (like a pulse oximeter) to measure and calculate values for ICG plasma disappearance and its associated values such as clearance rate and plasma retention rate. The technique involves intravenous injection of a small (0.25mg/kg) bolus dose of ICG. This can be repeated up to 20 times per 24hr period.
It is postulated that simultaneously measuring changes in hepatic blood flow and cardiac output will allow us to gather greater understanding of the haemodynamic changes associated with the prone position in the anaesthetised patient using current routine monitoring modalities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between the age of 18-65, presenting for neurosurgical procedures to the Queen's Medical Centre, Nottingham, England, UK.
Key inclusion criteria (4 listed)
- Adult patient
- ASA (American Society of Anaesthesiologists) I/II
- Surgery in prone position
- Classification of surgery as minor / moderate severity
Key exclusion criteria (12 listed)
- Inability to give consent to inclusion in trial
- Unable to speak or read English
- Age less than 18 years
- Age over 65 years
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Liver blood flow and function as measured by non-invasive determination of ICG excretion.
Time frame: During operative anaesthesia on day 1
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.
3 secondary outcomes
Validating LiDCO calibration between supine and prone positions
Time frame: During operative anaesthesia on day 1 of study
Evaluation of change in cardiac output on position change.
Time frame: During surgical anaesthesia on day 1 of study
Validation of preload predictors in the prone position.
Time frame: During surgical anaesthesia on day 1 of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prone Position and Cardiac Output, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iain Moppett, MB BChir MA MRCP FRCA DM (+44 (0) 115 8231009, iain.moppett@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver blood flow and function as measured by non-invasive determination of ICG excretion. (time frame: During operative anaesthesia on day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.