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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
  Purpose

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.


Condition
Hip Fractures
Anesthesia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of the Nexfin Non-invasive Cardiac Output Monitor in Patients Undergoing Hip Fracture Repair

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 24
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   80 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Elderly patients undergoing surgical repair of hip fracture

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe valvular heart disease
  • Taking lithium
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474824

Contacts
Contact: Iain K Moppett, DM FRCA MRCP 0115 823 0959 iain.moppett@nottingham.ac.uk

Locations
United Kingdom
Nottingham University Hospitals Recruiting
Nottingham, Notts, United Kingdom, NG7 2UH
Contact: Iain K Mopppett, DM FRCA MRCP     0115 823 0959     iain.moppett@nottingham.ac.uk    
Brighton and Sussex University Hospitals Not yet recruiting
Brighton, Sussex, United Kingdom, BN2 5BE
Contact: Stuart M White, MB BS MA         stuart.white@bsuh.nhs.uk    
Sponsors and Collaborators
University of Nottingham
Nottingham University Hospitals NHS Trust
Brighton and Sussex University Hospitals NHS Trust
Investigators
Principal Investigator: Iain K Moppett, DM FRCA MRCP University of Nottingham
  More Information

Publications:

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01474824     History of Changes
Other Study ID Numbers: 11090, 11/SW/0288
Study First Received: October 14, 2011
Last Updated: March 5, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Nottingham:
Cardiac output
Stroke volume

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
 Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on June 17, 2013