Validation of Nexfin Cardiac Output in Elderly Patients With Hip Fracture

NCT01474824 | Terminated

• 2 other identifiers: 1109011/SW/0288
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Hip Fractures; Anesthesia

Keywords

Cardiac output; Stroke volume

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• Utility of Nexfin monitor

  Intra-operative - average duration about 1 hour

• Adverse events associated with Nexfin monitor

  Intra-operative - average duration about one hour

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly patients undergoing surgical repair of hip fracture

You may qualify if:

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

You may not qualify if:

• Severe valvular heart disease
• Taking lithium

Sponsors & Collaborators

• University of Nottingham: lead
• Nottingham University Hospitals NHS Trust: collaborator
• Brighton and Sussex University Hospitals NHS Trust: collaborator

Study Sites (2)

Nottingham University Hospitals

Nottingham, Notts, NG7 2UH, United Kingdom

Location

Brighton and Sussex University Hospitals

Brighton, Sussex, BN2 5BE, United Kingdom

Location

Related 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.

  PMID: 21955538 BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Iain K Moppett, DM FRCA MRCP

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2011
• First Posted: November 18, 2011
• Study Start: January 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

GB (2)