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This is an observational pilot study of supernormal oxygen delivery goal for patients with proximal femoral fracture.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supernormal oxygen delivery goal therapy | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supernormal oxygen delivery goal therapy | Procedure | A 10% increase in stroke volume (SV) after fluid challenge (5 ml/kg) with Ringer's lactate solution will be deemed positive. Oxygen delivery will be check when fluid challenge becomes negative. If oxygen delivery index (DO2I) can not be greater than 600 mL/m2, then dobutamine will be started at a dose of 2.5 μg/kg/min and increased by the same increment every 20 minutes until the described target is reached or until a maximal dose of 10 μg/kg/min is given. Dobutamine is decreased in dose or discontinued if the heart rate is above 100 beats per minute or shows signs of cardiac ischemia. Blood transfusions will be used to maintain a hemoglobin concentration over 8mg/dL. |
| Measure | Description | Time Frame |
|---|---|---|
| Oxgen delivery index | To attain a improved oxygen delivery index at the end of 4 hour goal-directed therapy | At the end of 4 hour goal-directed therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Hear rate augmentation | Day 1 | |
| Hemodynamic response | Including stroke volume, cardiac index, base excess, lactate, hemoglobin, and urine output. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangcai Ruan, MD, PhD | Contact | +8620-81048306 | xc_ruan@hotmail.com | |
| Jingwen Guo | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Xiangcai Ruan, MD., PhD. | Guangzhou First Municipal People's Hospital,Guangzhou,Guangdong,China,510180 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou First Municipal People's Hospital | Guangzhou | Guangdong | 510180 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25010820 | Result | Pestana D, Espinosa E, Eden A, Najera D, Collar L, Aldecoa C, Higuera E, Escribano S, Bystritski D, Pascual J, Fernandez-Garijo P, de Prada B, Muriel A, Pizov R. Perioperative goal-directed hemodynamic optimization using noninvasive cardiac output monitoring in major abdominal surgery: a prospective, randomized, multicenter, pragmatic trial: POEMAS Study (PeriOperative goal-directed thErapy in Major Abdominal Surgery). Anesth Analg. 2014 Sep;119(3):579-587. doi: 10.1213/ANE.0000000000000295. | |
| 24841970 |
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| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D000092526 | Proximal Femoral Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
| D005265 | Femoral Neck Fractures |
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|
| fluid volume administrated | intraoperatively |
| Length of hospital stay | Day 30 |
| Postoperative morbidity | day 5 |
| Result |
| Bennett-Guerrero E. Hemodynamic goal-directed therapy in high-risk surgical patients. JAMA. 2014 Jun 4;311(21):2177-8. doi: 10.1001/jama.2014.5306. No abstract available. |
| 24010849 | Result | Salzwedel C, Puig J, Carstens A, Bein B, Molnar Z, Kiss K, Hussain A, Belda J, Kirov MY, Sakka SG, Reuter DA. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care. 2013 Sep 8;17(5):R191. doi: 10.1186/cc12885. |
| 23274782 | Result | 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. |
| 21624138 | Result | 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. |
| 21048092 | Result | 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. |
| 23661403 | Result | 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. |
| 22897633 | Result | 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. |
| D006620 |
| Hip Fractures |
| D025981 | Hip Injuries |