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

Matthew D Wiles, William J D Whiteley, Chris G Moran, Iain K Moppett, Matthew D Wiles, William J D Whiteley, Chris G Moran, Iain K Moppett

Abstract

Background: Approximately 70,000 patients/year undergo surgery for repair of a fractured hip in the United Kingdom. This is associated with 30-day mortality of 9% and survivors have a considerable length of acute hospital stay postoperatively (median 26 days). Use of oesophageal Doppler monitoring to guide intra-operative fluid administration in hip fracture repair has previously been associated with a reduction in hospital stay of 4-5 days. Most hip fracture surgery is now performed under spinal anaesthesia. Oesophageal Doppler monitoring may be unreliable in the presence of spinal anaesthesia and most patients would not tolerate the probes. An alternative method of guiding fluid administration (minimally-invasive arterial pulse contour analysis) has been shown to reduce length of stay in high-risk surgical patients but has never been studied in hip fracture surgery.

Methods: Single-centre randomised controlled parallel group trial. Randomisation by website using computer generated concealed tables.

Setting: University hospital in UK.

Participants: 128 patients with acute primary hip fracture listed for operative repair under spinal anaesthesia and aged > 65 years.

Intervention: Stroke volume guided intra-operative fluid management. Continuous measurement of SV recorded by a calibrated cardiac output monitor (LiDCOplus). Maintenance fluid and 250 ml colloid boluses given to achieve sustained 10% increases in stroke volume.

Control group: fluid administration at the responsible (blinded) anaesthetist's discretion. The intervention terminates at the end of the surgical procedure and post-operative fluid management is at the responsible anaesthetist's discretion.

Primary outcome: length of acute hospital stay is determined by a blinded team of clinicians. Secondary outcomes include number of complications and total cost of care. Funding NIHR/RfPB: PB-PG-0407-13073.

Trial registration: Current Controlled Trials ISRCTN88284896.

Figures

Figure 1
Figure 1
Flow chart for administration of colloid boluses in the intervention group. Changes in stroke volume are used to guide the administration of colloid boluses. The aim is give colloid boluses to achieve cardiac filling near the top of the Starling curve. The algorithm is interpreted in the light of clinical conditions.

References

    1. Health Episode Statistics Online. Primary Diagnosis: 4 Character, S72.0-S72.2. 2007-2008. [Accessed 5 Sep 2011]
    1. World Health Organization. Falls Prevention in Older Age. Geneva: WHO Press; 2007. [Accessed 5 Sep 2011]
    1. White S, Griffiths R, Holloway J, Shannon A. Anaesthesia for proximal femoral fracture in the UK: first report from the NHS Hip Fracture Anaesthesia Network. Anaesthesia. 2010;65(3):243–248. doi: 10.1111/j.1365-2044.2009.06208.x.
    1. The National Hip Fracture Database National Report 2010 - Extended version. [Accessed 21 Aug 2011]
    1. UK Statistics Authority. Office for National Statistics. [Accessed 5 Sep 2011]
    1. White SM, Griffiths R. Projected incidence of proximal femoral fracture in England: A report from the Hip Fracture Anaesthesia Network (HIPFAN) Injury. 2011.
    1. Holt G, Smith R, Duncan K, Hutchison JD, Reid D. Changes in population demographic and the future incidence of hip fracture. Injury. 2009;40(7):722–6. doi: 10.1016/j.injury.2008.11.004.
    1. Foss NB, Kehlet H. Hidden blood loss after surgery for hip fracture. J Bone Joint Surg (Brit) 2006;88(8):1053–1059. doi: 10.1302/0301-620X.88B8.17534.
    1. Roche JJW, Wenn RT, Sahota O, Moran CG. Effect of comorbidities and postoperative complications on mortality after hip fracture in elderly people: prospective observational cohort study. Br Med J. 2005;331(7529):1374–9. doi: 10.1136/bmj.38643.663843.55.
    1. Mythen MG, Webb AR. Perioperative plasma volume expansion reduces the incidence of gut mucosal hypoperfusion during cardiac surgery. Arch Surg. 1995;130(4):423–9.
    1. Gan TJ, Soppitt A, Maroof M. et al.Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002;97(4):820–6. doi: 10.1097/00000542-200210000-00012.
    1. Shoemaker WC, Montgomery ES, Kaplan E, Elwyn DH. Physiologic patterns in surviving and non-surviving shock patients. Use of sequential cardiorespiratory variables in defining criteria for therapeutic goals and early warning of death. Arch Surg. 1973;106(5):630–6.
    1. Sinclair S, James S, Singer M. Intraoperative intravascular volume optimisation and length of hospital stay after repair of proximal femoral fracture: randomised controlled trial. BMJ. 1997;315(7113):909–912.
    1. Venn R, Steele A, Richardson P, Polniecki J, Grounds M, Newman P. Randomized controlled trial to investigate influence of the fluid challenge on duration of hospital stay and peri-operative morbidity in patients with hip fractures. Br J Anaesth. 2002;88(1):65–71. doi: 10.1093/bja/88.1.65.
    1. Price JD, Sear JJW, Venn RRM. Perioperative fluid volume optimization following proximal femoral fracture. Cochrane Database of Systematic Reviews. 2004. p. CD003004.
    1. Parker MJ, Griffiths R, Boyle A. Preoperative saline versus gelatine for hip fracture patients; a randomized trial of 396 patients. Br J Anaesth. 2004;92(1):67–70. doi: 10.1093/bja/aeh006.
    1. Urwin S, Parker M, Griffiths R. General vs Regional Anaesthesia for hip fractured surgery: meta-analysis of randomized trials. Br J Anaesth. 2000;84(4):450–5.
    1. English JD, Moppett IK. Evaluation of a trans-oesophageal Doppler probe in awake subjects. Anaesthesia. 2005;60(7):720–1.
    1. Leather HA, Wouters PF. Oesophageal Doppler monitoring overestimates cardiac output during lumbar epidural anaesthesia. Br J Anaesth. 2001;86(6):794–7. doi: 10.1093/bja/86.6.794.
    1. Morgan P, Al-Subaie N, Rhodes A. Minimally invasive cardiac output monitoring. Curr Opinion Crit Care. 2008;14(3):322–6. doi: 10.1097/MCC.0b013e3282fd6e4a.
    1. Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds MR, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial. Critical Care. 2005;9(6):R687–R693. doi: 10.1186/cc3887.
    1. Maxwell MJ, Moran CG, Moppett IK. Development and validation of a preoperative scoring system to predict 30 day mortality in patients undergoing hip fracture surgery. Br J Anaesth. 2008;101(4):511–7. doi: 10.1093/bja/aen236.
    1. Wiles MD, Moran CG, Sahota O, Moppett IK. Nottingham Hip Fracture Score as a predictor of one year mortality in patients undergoing surgical repair of fractured neck of femur. Br J Anaesth. 2011;106(4):501–4. doi: 10.1093/bja/aeq405.
    1. Moppett IK, Wiles MD, Moran CG, Sahota O. The Nottingham Hip Fracture Score as a predictor of early discharge following fractured neck of femur. Age Ageing. 2011. in press .
    1. Magaziner J, Simonsick EM, Kashner TM, Hebel JR, Kenzora JE. Survival experience of aged hip fracture patients. Am J Public Health. 1989;79(3):274–8. doi: 10.2105/AJPH.79.3.274.
    1. Muraki S, Yamamoto S, Ishibashi H, Nakamura K. Factors associated with mortality following hip fracture in Japan. J Bone Miner Metab. 2006;24(2):100–4. doi: 10.1007/s00774-005-0654-z.
    1. Nightingale S, Holmes J, Mason J, House A. Psychiatric illness and mortality after hip fracture. Lancet. 2001;357(9264):1264–5. doi: 10.1016/S0140-6736(00)04421-4.
    1. International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use. Guideline For Good Clinical Practice E6 (R1). Current Step 4 Version. 1996.
    1. Hamilton TT, Huber LM, Jessen ME. PulseCO: A less-invasive method to monitor cardiac output from arterial pressure after cardiac surgery. Ann Thorac Surg. 2002;74(4):S1408–12. doi: 10.1016/S0003-4975(02)04059-6.
    1. Ehlers KC, Mylrea KC, Waterson CK, Calkins JM. Cardiac output measurements. A review of current techniques and research. Ann Biomed Eng. 1986;14(3):219–239. doi: 10.1007/BF02584272.
    1. Jonas M, Linton R, O'Brien T. The pharmacokinetics of intravenous lithium chloride in patients and normal volunteers. J Trace Microbe Techn. 2001;19(2):313–20. doi: 10.1081/TMA-100002220.
    1. Linton R, Band D, O'Brien T, Jonas MM, Leach R. Lithium dilution cardiac output measurement: A comparison with thermodilution. Critical Care Medicine. 1997;25(11):1796–1800. doi: 10.1097/00003246-199711000-00015.
    1. Linton RA, Jonas MM, Tibby SM, Murdoch IA, O'Brien TK, Linton NW, Band DM. Cardiac output measured by lithium dilution and transpulmonary thermodilution in patients in a paediatric intensive care unit. Intensive Care Med. 2002;26(10):1507–11.
    1. Pittman J, Bar Yosef S, SumPing J, Sherwood M, Mark J. Continuous cardiac output monitoring with pulse contour analysis: A comparison with lithium indicator dilution cardiac output measurement. Crit Care Med. 2002;33(9):2015–2021.
    1. Meyhoff CS, Hesselbjerg L, Koscielniak-Nielsen Z, Rasmussen LS. Biphasic cardiac output changes during onset of spinal anaesthesia in elderly patients. Eur J Anaesthesiol. 2007;24(9):770–5. doi: 10.1017/S0265021507000427.
    1. User's manual: LiDCOplus Hemodynamic monitor Version 4. Cambridge: LiDCO; 2006.
    1. Department of Health Payment by Results Team. Payment by Results Guidance for 2010-11. London: Department of Health; 2010.
    1. WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. [Accessed 21 Aug 2011]
    1. Department of Health Research Governance Framework for Health and Social care. 2. [Accessed 21 Aug 2011]
    1. Parker MJ, Handol HHG, Griffiths R. Anaesthesia for hip fracture surgery in adults. Cochrane Database of Systematic Reviews. 2004;4:CD000521.
    1. British Orthopaedic Association Standards for Trauma (BOAST) Boast 1: Hip Fracture in the Older Person. 2007. [Accessed 5 Sep 2011]
    1. Foss NB, Kehlet H. Mortality analysis in hip fracture patients: implications for design of future outcome trials. Br J Anaesth. 2005;94(1):24–9.
    1. Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg Br. 1993;75(5):797–8.
    1. Fox KM, Hawkes WG, Hebel JR, Felsenthal G, Clark M, Zimmerman SI, Kenzora JE, Magaziner J. Mobility after hip fracture predicts health outcomes. J Am Geriatr Soc. 1998;46(2):169–73.
    1. Lawrence TM, White CT, Moran CG. The current hospital costs of treating hip fractures. Injury. 2005;36(1):88–91. doi: 10.1016/j.injury.2004.06.015.

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