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

September 23, 2019 updated by: Second Affiliated Hospital of Wenzhou Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 32500
        • Recruiting
        • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: New "guideline"
New "guideline" anesthesia strategy team (Group A)
Procedure: New "guideline" anesthesia strategy team
New "guideline" anesthesia strategy team
No Intervention: Current strategy
Current anesthesia strategy team (Group B)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Score(VAS)
Time Frame: within two days after surgery
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
Time Frame: post-operation to discharge, an average of 2 weeks
The incidence of postoperative complications
post-operation to discharge, an average of 2 weeks
Death rate
Time Frame: Within 30 days and 1 year after surgery
Mortality for postoperative of 30 days and 1 year
Within 30 days and 1 year after surgery
Survival time
Time Frame: up to one year after surgery
Observed length of time after surgery to death within one year
up to one year after surgery
Compliance score
Time Frame: Duration of hospital stay, an average of 2 weeks
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
Time Frame: Up to discharge,an average of 2 weeks
Length of time stay in hospital
Up to discharge,an average of 2 weeks
Cost
Time Frame: Length of hospital stay,an average of 2 weeks
Total cost in hospital and expenditure for anesthesia
Length of hospital stay,an average of 2 weeks
MMSE
Time Frame: Two days after surgery
Cognitive function with Mini-Mental State Examination (MMSE)
Two days after surgery
Satisfaction score
Time Frame: Two weeks before discharge
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

January 18, 2018

First Submitted That Met QC Criteria

February 8, 2018

First Posted (Actual)

February 12, 2018

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 23, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHoWMU-CR2017-03-110

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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