Validation of Nexfin Cardiac Output in Elderly Patients With Hip Fracture

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of Nottingham
Sponsor:
Collaborators:
Nottingham University Hospitals NHS Trust
Brighton and Sussex University Hospitals NHS Trust
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01474824
First received: October 14, 2011
Last updated: March 5, 2013
Last verified: March 2013

October 14, 2011
March 5, 2013
January 2013
June 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Analysis of agreement between Nexfin cardiac output and the calibrated cardiac output measured by LiDCOplus
Same as current
Complete list of historical versions of study NCT01474824 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Recording of adverse events associated with use of the Nexfin monitor
Same as current
Not Provided
Not Provided
 
Validation of Nexfin Cardiac Output in Elderly Patients With Hip Fracture
Validation of the Nexfin Non-invasive Cardiac Output Monitor in Patients Undergoing Hip Fracture Repair

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Elderly patients undergoing surgical repair of hip fracture

  • Hip Fractures
  • Anesthesia
Not Provided
Not Provided
Wiles MD, Whiteley WJ, Moran CG, Moppett IK. The use of LiDCO based fluid management in patients undergoing hip fracture surgery under spinal anaesthesia: neck of femur optimisation therapy - targeted stroke volume (NOTTS): study protocol for a randomized controlled trial. Trials. 2011 Sep 28;12:213. doi: 10.1186/1745-6215-12-213.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
December 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged over 80
  • Able to give their own informed consent

Exclusion Criteria:

  • Severe valvular heart disease
  • Taking lithium
Both
80 Years and older
No
Contact: Iain K Moppett, DM FRCA MRCP 0115 823 0959 iain.moppett@nottingham.ac.uk
United Kingdom
 
NCT01474824
11090, 11/SW/0288
No
University of Nottingham
University of Nottingham
  • Nottingham University Hospitals NHS Trust
  • Brighton and Sussex University Hospitals NHS Trust
Principal Investigator: Iain K Moppett, DM FRCA MRCP University of Nottingham
University of Nottingham
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP