Supernormal Goal for Proximal Femur Fracture

Study Overview
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Brief Summary
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This is an observational pilot study of supernormal oxygen delivery goal for patients with proximal femoral fracture.

Detailed Description
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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.

Official Title
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Supernormal Oxygen Delivery May Not be a Valid Goal for Patients With Proximal Femur Fracture. An Observational Pilot Study

Conditions
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Femoral Fractures

Intervention / Treatment
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* Procedure: Supernormal oxygen delivery goal therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Supernormal oxygen delivery goal therapy<br>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. | Procedure: Supernormal oxygen delivery goal therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| fluid volume administrated |  | intraoperatively | 
| Length of hospital stay |  | Day 30 | 
| Postoperative morbidity |  | day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxygen delivery, proximal femoral fracture, goal-directed therapy