Validation of Nexfin Cardiac Output in Elderly Patients With Hip Fracture

Terminated

• Conditions: Hip Fractures; Anesthesia

• Registration Number: NCT01474824
• Lead Sponsor: University of Nottingham

Brief Summary

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.

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 Timeline

• Study First Submitted: 2011-10-14
• Study First Submitted QC: 2011-11-15
• Study First Posted: 2011-11-18
• Study Start: 2013-01
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-03
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

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

Exclusion Criteria

• Severe valvular heart disease
• Taking lithium

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bias and limits of agreement of Nexfin recorded cardiac output compared with LiDCOplus	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

Name	Time	Method
Bias and limits of agreement for change in cardiac output measured by Nexfin compared with LiDCO	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	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	Intra-operative - average duration about one hour	Recording of adverse events associated with use of the Nexfin monitor

Trial Locations

Locations (2)

Brighton and Sussex University Hospitals; 🇬🇧 Brighton, Sussex, United Kingdom

Nottingham University Hospitals; 🇬🇧 Nottingham, Notts, United Kingdom