Clinical trial NCT02194101: Supernormal Goal for Proximal Femur Fracture
Official title: Supernormal Oxygen Delivery May Not be a Valid Goal for Patients With Proximal Femur Fracture. An Observational Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Femoral Fractures
Keywords: oxygen delivery
proximal femoral fracture
goal-directed therapy
Lead sponsor: Guangzhou First People's Hospital
Sponsor class: OTHER
First posted: 2014-07-18
Enrollment: 30
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be aged over 70 yr and weight over 35 kg, and undergoing proximal femur fracture (PFF) surgery under peripheral nerve block and laryngeal mask airway anesthesia.

Brief summary: This is an observational pilot study of supernormal oxygen delivery goal for patients with proximal femoral fracture.

Detailed description: Augmentation of oxygen delivery using fluids with or without inotropes has been shown to improve surgical outcome in high-risk patients. Patients with proximal femoral fracture are considered high risk. However, most of this cohort elderly patients have poor cardiovascular condition and may not achieve the oxygen delivery goal. We will perform an observational pilot study whether the supernormal oxygen delivery is a valid hemodynamic goal for patients with proximal femoral fracture.

Eligibility criteria: Inclusion Criteria:

* Patients aged over 70 yr
* Weight over 35 kg
* Underwent proximal femur fracture (PFF) surgery under peripheral nerve block and laryngeal mask airway anesthesia.

Exclusion Criteria:

* Patients who could be harmed due to the treatment (ongoing myocardial infarction, chronic dialysis)
* Monoamine oxidase inhibitor use within the last 14 days
* Pathological fractures and conditions
* Inability to give informed consent(as judged by a research team member)
* Anticipated difficulties obtaining data during the first postoperative year (as judged by a research team member)

Primary outcomes:
measure: Oxgen delivery index
timeFrame: At the end of 4 hour goal-directed therapy
Secondary outcomes:
measure: Hear rate augmentation
timeFrame: Day 1
measure: Hemodynamic response
timeFrame: Day 1
measure: fluid volume administrated
timeFrame: intraoperatively
measure: Length of hospital stay
timeFrame: Day 30
measure: Postoperative morbidity
timeFrame: day 5
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou First Municipal People's Hospital
state: Guangdong
Study officials:
affiliation: Guangzhou First Municipal People's Hospital,Guangzhou,Guangdong,China,510180
name: Xiangcai Ruan, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Bartha E, Arfwedson C, Imnell A, Fernlund ME, Andersson LE, Kalman S. Randomized controlled trial of goal-directed haemodynamic treatment in patients with proximal femoral fracture. Br J Anaesth. 2013 Apr;110(4):545-53. doi: 10.1093/bja/aes468. Epub 2012 Dec 28.
citation: Cecconi M, Fasano N, Langiano N, Divella M, Costa MG, Rhodes A, Della Rocca G. Goal-directed haemodynamic therapy during elective total hip arthroplasty under regional anaesthesia. Crit Care. 2011;15(3):R132. doi: 10.1186/cc10246. Epub 2011 May 30.
citation: Davies SJ, Yates D, Wilson RJ. Dopexamine has no additional benefit in high-risk patients receiving goal-directed fluid therapy undergoing major abdominal surgery. Anesth Analg. 2011 Jan;112(1):130-8. doi: 10.1213/ANE.0b013e3181fcea71. Epub 2010 Nov 3.
citation: Grocott MP, Dushianthan A, Hamilton MA, Mythen MG, Harrison D, Rowan K; Optimisation Systematic Review Steering Group. Perioperative increase in global blood flow to explicit defined goals and outcomes after surgery: a Cochrane Systematic Review. Br J Anaesth. 2013 Oct;111(4):535-48. doi: 10.1093/bja/aet155. Epub 2013 May 9.
citation: Bisgaard J, Gilsaa T, Ronholm E, Toft P. Optimising stroke volume and oxygen delivery in abdominal aortic surgery: a randomised controlled trial. Acta Anaesthesiol Scand. 2013 Feb;57(2):178-88. doi: 10.1111/j.1399-6576.2012.02756.x. Epub 2012 Aug 17.