Validation of Nexfin Cardiac Output in Elderly Patients With Hip Fracture

Anesthesia Clinical Trial

Official title:

Validation of the Nexfin Non-invasive Cardiac Output Monitor in Patients Undergoing Hip Fracture Repair

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01474824
• Other study ID #: 11090
• Secondary ID: 11/SW/0288
• Status: Terminated
• Phase: N/A
• First received: October 14, 2011
• Last updated: December 3, 2014
• Start date: January 2013
• Est. completion date: October 2013

Study information

• Verified date: December 2014
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 80 Years and older

Eligibility

Inclusion Criteria:

• Aged over 80

• Able to give their own informed consent

Exclusion Criteria:

• Severe valvular heart disease

• Taking lithium

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia
• Fractures, Bone
• Hip Fractures

Locations

Country	Name	City	State
United Kingdom	Brighton and Sussex University Hospitals	Brighton	Sussex
United Kingdom	Nottingham University Hospitals	Nottingham	Notts

Sponsors (3)

Lead Sponsor	Collaborator
University of Nottingham	Brighton and Sussex University Hospitals NHS Trust, Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Adverse events associated with Nexfin monitor	Recording of adverse events associated with use of the Nexfin monitor	Intra-operative - average duration about one hour	Yes