Clinical trial NCT01474824: Validation of Nexfin Cardiac Output in Elderly Patients With Hip Fracture
Official title: Validation of the Nexfin Non-invasive Cardiac Output Monitor in Patients Undergoing Hip Fracture Repair
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hip Fractures
Anesthesia
Keywords: Cardiac output
Stroke volume
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Nottingham University Hospitals NHS Trust
name: Brighton and Sussex University Hospitals NHS Trust
First posted: 2011-11-18
Enrollment: 6
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients undergoing surgical repair of hip fracture

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Severe valvular heart disease
* Taking lithium

Primary outcomes:
measure: Bias and limits of agreement of Nexfin recorded cardiac output compared with LiDCOplus
timeFrame: During anaesthesia period of surgery - measurements will be complete within 30 minutes of starting anaesthesia
Secondary outcomes:
measure: Bias and limits of agreement for change in cardiac output measured by Nexfin compared with LiDCO
timeFrame: During anaesthesia period of surgery - measurements will be complete within 30 minutes of starting anaesthesia
measure: Utility of Nexfin monitor
timeFrame: Intra-operative - average duration about 1 hour
measure: Adverse events associated with Nexfin monitor
timeFrame: Intra-operative - average duration about one hour
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals
state: Notts
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospitals
state: Sussex
Study officials:
affiliation: University of Nottingham
name: Iain K Moppett, DM FRCA MRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.