Efficacy of Perioperative Anesthesia Care Bundle on Prognosis in Elderly Undergoing Hip Fracture Surgery

Study Overview
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Brief Summary
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This study is going to research the hypothesis that to strengthen the comprehensive treatment of perioperative anesthesia is possible to improve the prognosis of patients with hip fracture and reduce mortality. This is a randomized controlled pilot study aimed to elderly patients with hip fracture on one side and needing surgical treatment.

Detailed Description
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To evaluate the efficacy of perioperative anesthesia care bundle on prognosis in elderly undergoing hip fracture surgery; to assess the levels of compliance that current anesthesia management strategy of our hospital against the new guidelines; and to analyze the defects in the current anesthesia management strategy and collect data for further multi-center research, this single-center randomized controlled trial was conducted. The central stochastic system was adopted to determined the stratification factors by age, POSSUM score, whether there was tracheal intubation or laryngeal mask auxiliary ventilation. Therefore, there are two groups including the new version of guidelines anesthesia strategy group and existing anesthesia strategy group at a ratio of 1:1. The mortality is the primary indicator will be collected in 1,6,12 months after surgery. And VAS score, MMSE, length of hospital stay and so forth, which would be collected as the secondary indicators.

Official Title
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Efficacy of Perioperative Anesthesia Care Bundle on Prognosis in Elderly Undergoing Hip Fracture Surgery: a Single-center Randomized Controlled Trial

Conditions
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Anesthesia, Hip Fracture Surgery, Nursing

Intervention / Treatment
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* Procedure: New guideline anesthesia strategy team


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 75 years old; Patients with hip fracture purely and surgical treatment is scheduled. Exclusion Criteria: Surgical treatment has been performed after entering hospital; Multiple trauma: multiple fractures; chest, abdomen, pelvis and sacral trauma; severe head injury, etc. Refuse to sign informed consent; Investigator thinks he/she is inappropriate to carry out this study.

Ages Eligible for Study
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Minimum Age: 75 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New guideline<br>New guideline anesthesia strategy team (Group A) | Procedure: New guideline anesthesia strategy team<br>* New guideline anesthesia strategy team<br>|
| No Intervention: Current strategy<br>Current anesthesia strategy team (Group B) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality in 6 months of postoperative | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Score(VAS) | The intensity of postoperative pain using Visual Analogue Score(VAS), has a total score of 10 range from 0 to 10. Do higher values represent a severer pain. | within two days after surgery | 
| Complications | The incidence of postoperative complications | post-operation to discharge, an average of 2 weeks | 
| Death rate | Mortality for postoperative of 30 days and 1 year | Within 30 days and 1 year after surgery | 
| Survival time | Observed length of time after surgery to death within one year | up to one year after surgery | 
| Compliance score | The level of compliance of new guideline(from the ratio of (score:total score)), the ratio from 0% to 100% | Duration of hospital stay, an average of 2 weeks | 
| Hospital stay | Length of time stay in hospital | Up to discharge,an average of 2 weeks | 
| Cost | Total cost in hospital and expenditure for anesthesia | Length of hospital stay,an average of 2 weeks | 
| MMSE | Cognitive function with Mini-Mental State Examination (MMSE) | Two days after surgery | 
| Satisfaction score | Overall satisfaction of patients, with a range of 0 to 5 points. 0 point represents not satisfied at all and 5 points mean greatly satisfied. | Two weeks before discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Hip Fracture