Value of Nexfin SVV and PPV to predict fluid responsiveness during anaesthesia

ISRCTN ISRCTN49236605
DOI https://doi.org/10.1186/ISRCTN49236605
Secondary identifying numbers vol-001
Submission date
26/07/2012
Registration date
16/08/2012
Last edited
09/11/2015
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Alain Kalmar
Scientific

University Medical Center Groningen
Hanzeplein 1
Groningen
9700 RB
Netherlands

Study information

Study designRetrospective data analysis
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleValue of Nexfin SVV and PPV to predict fluid responsiveness during anaesthesia
Study objectivesThe dynamic preload variables (SSV and PPV) assessed by Nexfin, are better predictors to assess fluid responsiveness than blood pressure or heart rate
Ethics approval(s)Medisch Ethische Toetsingscommissie (METc), Universitair Medisch Centrum Groningen, 19/04/012, ref: metc2012/107
Health condition(s) or problem(s) studiedAnaesthesia
InterventionN/A
Intervention typeProcedure/Surgery
Primary outcome measureWe 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 measuresNo secondary outcome measures
Overall study start date01/11/2011
Completion date08/08/2012
Reason abandoned (if study stopped)Objectives no longer viable

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants80
Key inclusion criteria>18 years
Key exclusion criteriaUnable or unwilling to grant written informed consent for data analysis
Date of first enrolment01/11/2011
Date of final enrolment08/08/2012

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Center Groningen
Groningen
9700 RB
Netherlands

Sponsor information

University Medical Center Groningen (Netherlands)
Hospital/treatment centre

Hanzeplein 1
PO Box 30001
Groningen
9700 RB
Netherlands

Website http://www.umcg.nl/
ROR logo "ROR" https://ror.org/03cv38k47

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

Please note that this trial was stopped as of 28/11/2012.