Clinical trial NCT03429010: Efficacy of Perioperative Anesthesia Care Bundle on Prognosis in Elderly Undergoing Hip Fracture Surgery
Official title: Efficacy of Perioperative Anesthesia Care Bundle on Prognosis in Elderly Undergoing Hip Fracture Surgery: a Single-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Hip Fracture Surgery
Nursing
Keywords: Anesthesia
Hip Fracture
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 300
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients ≥ 75 years old;
2. Patients with hip fracture purely and surgical treatment is scheduled.

Exclusion Criteria:

1. Surgical treatment has been performed after entering hospital;
2. Multiple trauma: multiple fractures; chest, abdomen, pelvis and sacral trauma; severe head injury, etc.
3. Refuse to sign informed consent;
4. Investigator thinks he/she is inappropriate to carry out this study.

Primary outcomes:
measure: Mortality
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Visual Analogue Score(VAS)
timeFrame: within two days after surgery
measure: Complications
timeFrame: post-operation to discharge, an average of 2 weeks
measure: Death rate
timeFrame: Within 30 days and 1 year after surgery
measure: Survival time
timeFrame: up to one year after surgery
measure: Compliance score
timeFrame: Duration of hospital stay, an average of 2 weeks
measure: Hospital stay
timeFrame: Up to discharge,an average of 2 weeks
measure: Cost
timeFrame: Length of hospital stay,an average of 2 weeks
measure: MMSE
timeFrame: Two days after surgery
measure: Satisfaction score
timeFrame: Two weeks before discharge
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: