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

Anesthesia Clinical Trial

— EPAPHUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03429010
• Other study ID #: SAHoWMU-CR2017-03-110
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2019
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Fractures, Bone
• Hip Fracture Surgery
• Hip Fractures
• Nursing

Intervention

Procedure:
• New "guideline" anesthesia strategy team
New "guideline" anesthesia strategy team

Locations

Country	Name	City	State
China	The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality in 6 months of postoperative	6 months after surgery
Secondary	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
Secondary	Complications	The incidence of postoperative complications	post-operation to discharge, an average of 2 weeks
Secondary	Death rate	Mortality for postoperative of 30 days and 1 year	Within 30 days and 1 year after surgery
Secondary	Survival time	Observed length of time after surgery to death within one year	up to one year after surgery
Secondary	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
Secondary	Hospital stay	Length of time stay in hospital	Up to discharge,an average of 2 weeks
Secondary	Cost	Total cost in hospital and expenditure for anesthesia	Length of hospital stay,an average of 2 weeks
Secondary	MMSE	Cognitive function with Mini-Mental State Examination (MMSE)	Two days after surgery
Secondary	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