Back to resultsEfficacy of Perioperative Anesthesia Care Bundle on Prognosis in Elderly Undergoing Hip Fracture Surgery (EPAPHUS)
Primary Purpose
Anesthesia, Hip Fracture Surgery, Nursing
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
New "guideline" anesthesia strategy team
Sponsored by
About this trial
This is an interventional treatment trial for Anesthesia focused on measuring Anesthesia, Hip Fracture
Eligibility Criteria
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.
Sites / Locations
- The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
New "guideline"
Current strategy
Arm Description
New "guideline" anesthesia strategy team (Group A)
Current anesthesia strategy team (Group B)
Outcomes
Primary Outcome Measures
Mortality
Mortality in 6 months of postoperative
Secondary Outcome Measures
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.
Complications
The incidence of postoperative complications
Death rate
Mortality for postoperative of 30 days and 1 year
Survival time
Observed length of time after surgery to death within one year
Compliance score
The level of compliance of new "guideline"(from the ratio of (score:total score)), the ratio from 0% to 100%
Hospital stay
Length of time stay in hospital
Cost
Total cost in hospital and expenditure for anesthesia
MMSE
Cognitive function with Mini-Mental State Examination (MMSE)
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.
Full Information
NCT ID
NCT03429010
First Posted
January 18, 2018
Last Updated
September 23, 2019
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03429010
Brief Title
Efficacy of Perioperative Anesthesia Care Bundle on Prognosis in Elderly Undergoing Hip Fracture Surgery
Acronym
EPAPHUS
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
November 1, 2019 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Wenzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Hip Fracture Surgery, Nursing
Keywords
Anesthesia, Hip Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
New "guideline"
Arm Type
Experimental
Arm Description
New "guideline" anesthesia strategy team (Group A)
Arm Title
Current strategy
Arm Type
No Intervention
Arm Description
Current anesthesia strategy team (Group B)
Intervention Type
Procedure
Intervention Name(s)
New "guideline" anesthesia strategy team
Intervention Description
New "guideline" anesthesia strategy team
Primary Outcome Measure Information:
Title
Mortality
Description
Mortality in 6 months of postoperative
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
Visual Analogue Score(VAS)
Description
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.
Time Frame
within two days after surgery
Title
Complications
Description
The incidence of postoperative complications
Time Frame
post-operation to discharge, an average of 2 weeks
Title
Death rate
Description
Mortality for postoperative of 30 days and 1 year
Time Frame
Within 30 days and 1 year after surgery
Title
Survival time
Description
Observed length of time after surgery to death within one year
Time Frame
up to one year after surgery
Title
Compliance score
Description
The level of compliance of new "guideline"(from the ratio of (score:total score)), the ratio from 0% to 100%
Time Frame
Duration of hospital stay, an average of 2 weeks
Title
Hospital stay
Description
Length of time stay in hospital
Time Frame
Up to discharge,an average of 2 weeks
Title
Cost
Description
Total cost in hospital and expenditure for anesthesia
Time Frame
Length of hospital stay,an average of 2 weeks
Title
MMSE
Description
Cognitive function with Mini-Mental State Examination (MMSE)
Time Frame
Two days after surgery
Title
Satisfaction score
Description
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.
Time Frame
Two weeks before discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
32500
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TING LI
Phone
13587876896
Email
feclinicalresearch@163.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Perioperative Anesthesia Care Bundle on Prognosis in Elderly Undergoing Hip Fracture Surgery
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