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.

Study Overview

• Status: Terminated
• Conditions: Hip Fractures; Anesthesia

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• United Kingdom
  • Notts
    • Nottingham, Notts, United Kingdom, NG7 2UH
      • Nottingham University Hospitals
  • Sussex
    • Brighton, Sussex, United Kingdom, BN2 5BE
      • Brighton and Sussex University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Elderly patients undergoing surgical repair of hip fracture

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Severe valvular heart disease
• Taking lithium

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bias and limits of agreement of Nexfin recorded cardiac output compared with LiDCOplus	Analysis of agreement between Nexfin cardiac output and the calibrated cardiac output measured by LiDCOplus	During anaesthesia period of surgery - measurements will be complete within 30 minutes of starting anaesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bias and limits of agreement for change in cardiac output measured by Nexfin compared with LiDCO	Comparison of relative changes in cardiac output recorded by Nexfin and LiDCO in response to intra-anaesthesia / intra-operative events (fluid administration, drug administration)	During anaesthesia period of surgery - measurements will be complete within 30 minutes of starting anaesthesia
Utility of Nexfin monitor	Proportion of time during anaesthesia and surgery when a valid signal is obtained from the Nexfin device.	Intra-operative - average duration about 1 hour
Adverse events associated with Nexfin monitor	Recording of adverse events associated with use of the Nexfin monitor	Intra-operative - average duration about one hour

Collaborators and Investigators

• Sponsor: University of Nottingham
• Collaborators: Nottingham University Hospitals NHS Trust; Brighton and Sussex University Hospitals NHS Trust
• Investigators: Principal Investigator: Iain K Moppett, DM FRCA MRCP, University of Nottingham

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: October 14, 2011
• First Submitted That Met QC Criteria: November 15, 2011
• First Posted (ESTIMATE): November 18, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 4, 2014
• Last Update Submitted That Met QC Criteria: December 3, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Cardiac output; Stroke volume
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: 11090 (DAIDS ES Registry Number); 11/SW/0288 (OTHER: NRES)