Validation of Nexfin Cardiac Output in Elderly Patients With Hip Fracture
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01474824
(Unable to recruit sufficient participants)
: November 18, 2011
Last Update Posted
: December 4, 2014
University of Nottingham
Nottingham University Hospitals NHS Trust
Brighton and Sussex University Hospitals NHS Trust
Measurement of how much blood the heart pumps may be useful in guiding how much intravenous fluid to give patients during surgery. The current monitors either require special drips (arterial and/or central lines) or a probe inserted into the oesophagus (food pipe) which may limit their use. Newer monitors are available which are completely non-invasive and seem to work well in younger patients. Patients with hip fracture are elderly and frail. The investigators wish to see whether the newer non-invasive monitor works well enough compared to the current monitors in this group of patients. If it does this may allow more of these patients to be monitored in this way.
Condition or disease
The investigators wish to compare the accuracy of the newer, non-invasive monitor (Nexfin) against a more established minimally invasive monitor (LiDCO). The LiDCO has a calibration system which allows the absolute accuracy of the Nexfin to be established.
Bias and limits of agreement of Nexfin recorded cardiac output compared with LiDCOplus [ Time Frame: During anaesthesia period of surgery - measurements will be complete within 30 minutes of starting anaesthesia ]
Analysis of agreement between Nexfin cardiac output and the calibrated cardiac output measured by LiDCOplus
Secondary Outcome Measures
Bias and limits of agreement for change in cardiac output measured by Nexfin compared with LiDCO [ Time Frame: During anaesthesia period of surgery - measurements will be complete within 30 minutes of starting anaesthesia ]
Comparison of relative changes in cardiac output recorded by Nexfin and LiDCO in response to intra-anaesthesia / intra-operative events (fluid administration, drug administration)
Utility of Nexfin monitor [ Time Frame: Intra-operative - average duration about 1 hour ]
Proportion of time during anaesthesia and surgery when a valid signal is obtained from the Nexfin device.
Adverse events associated with Nexfin monitor [ Time Frame: Intra-operative - average duration about one hour ]
Recording of adverse events associated with use of the Nexfin monitor
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
80 Years and older (Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Elderly patients undergoing surgical repair of hip fracture