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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01474824

Enrollment

Registered

2011-11-18

Start date

2013-01-31

Completion date

2013-10-31

Last updated

2014-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Hip Fractures

Keywords

Cardiac output, Stroke volume

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

80 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Severe valvular heart disease * Taking lithium

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United Kingdom

Outcome results