Supernormal Goal for Proximal Femur Fracture

• Conditions: Femoral Fractures
• Interventions: Procedure: Supernormal oxygen delivery goal therapy

• Registration Number: NCT02194101
• Lead Sponsor: Guangzhou First People's Hospital

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.

Study Timeline

• Status Verified: 2014-07
• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-16
• Last Update Submitted: 2014-07-16
• Study First Posted: 2014-07-18
• Last Update Posted: 2014-07-18
• Study Start: 2014-08
• Primary Completion: 2015-04
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Supernormal oxygen delivery goal therapy	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.

Primary Outcome Measures

Name	Time	Method
Oxgen delivery index	At the end of 4 hour goal-directed therapy	To attain a improved oxygen delivery index at the end of 4 hour goal-directed therapy

Secondary Outcome Measures

Name	Time	Method
Hear rate augmentation	Day 1
Hemodynamic response	Day 1	Including stroke volume, cardiac index, base excess, lactate, hemoglobin, and urine output.
fluid volume administrated	intraoperatively
Length of hospital stay	Day 30
Postoperative morbidity	day 5

Trial Locations

Locations (1)

Guangzhou First Municipal People's Hospital; 🇨🇳 Guangzhou, Guangdong, China