Plain English Summary
Background and study aims
Patients undergoing surgery often require fluids to be infused into their veins to compensate for blood loss. However, giving patients fluids is only beneficial if it increases the volume of blood pumped by the heart, but this ‘fluid responsiveness’ varies depending on the patient’s blood volume. This is mostly assessed using invasive techniques, so current practice does not include this assessment in most patients under anesthetic. The Nexfin monitor uses a non-invasive finger cuff to assess blood parameters and can be used in all patients under general anesthetic. The aim of this study is to assess the value of using the Nexfin monitor to predict the fluid responsiveness of patients under anesthetic.
Who can participate?
Patients aged over 18 undergoing surgery under general anesthetic.
What does the study involve?
During normal routine clinical practice, we record the patients’ hemodynamic parameters (e.g., blood pressure, volume of blood pumped by the heart, heart rate) using the Nexfin monitor during procedures where fluid administration was required. We evaluate the changes in these parameters during fluid administration and their value in predicting the patients’ fluid responsiveness.
What are the possible benefits and risks of participating?
There are no benefits or risks involved.
Where is the study run from?
University Medical Center Groningen (Netherlands).
When is the study starting and how long is it expected to run for?
November 2011 to August 2012.
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Alain Kalmar
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
vol-001
Study information
Scientific title
Value of Nexfin SVV and PPV to predict fluid responsiveness during anaesthesia
Acronym
Study hypothesis
The dynamic preload variables (SSV and PPV) assessed by Nexfin, are better predictors to assess fluid responsiveness than blood pressure or heart rate
Ethics approval
Medisch Ethische Toetsingscommissie (METc), Universitair Medisch Centrum Groningen, 19/04/012, ref: metc2012/107
Study design
Retrospective data analysis
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Anaesthesia
Intervention
N/A
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
We will evaluate the evolution of hemodynamic parameters during the period of fluid administration and the value of the dynamic preload-variables to predict fluid responsiveness
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/11/2011
Overall trial end date
08/08/2012
Reason abandoned (if study stopped)
Objectives no longer viable
Eligibility
Participant inclusion criteria
>18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
Unable or unwilling to grant written informed consent for data analysis
Recruitment start date
01/11/2011
Recruitment end date
08/08/2012
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Groningen
Groningen
9700 RB
Netherlands
Sponsor information
Organisation
University Medical Center Groningen (Netherlands)
Sponsor details
Hanzeplein 1
PO Box 30001
Groningen
9700 RB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
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
Basic results (scientific)
Publication list