Validation of Nexfin Cardiac Output in Elderly Patients With Hip Fracture

This study is currently recruiting participants.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 14, 2011

Last Updated Date

March 5, 2013

Start Date ^ICMJE

January 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01474824 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Validation of Nexfin Cardiac Output in Elderly Patients With Hip Fracture

Official Title ^ICMJE

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

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Elderly patients undergoing surgical repair of hip fracture

Condition ^ICMJE

Hip Fractures
Anesthesia

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Aged over 80
Able to give their own informed consent

Exclusion Criteria:

Severe valvular heart disease
Taking lithium

Gender

Both

Ages

80 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Iain K Moppett, DM FRCA MRCP

0115 823 0959

iain.moppett@nottingham.ac.uk

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01474824

Other Study ID Numbers ^ICMJE

11090, 11/SW/0288

Has Data Monitoring Committee

Responsible Party

University of Nottingham

Study Sponsor ^ICMJE

University of Nottingham

Collaborators ^ICMJE

Nottingham University Hospitals NHS Trust
Brighton and Sussex University Hospitals NHS Trust

Investigators ^ICMJE

Principal Investigator:

Iain K Moppett, DM FRCA MRCP

University of Nottingham

Information Provided By

University of Nottingham

Verification Date

March 2013

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

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