ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03429010
Recruitment Status : Not yet recruiting
First Posted : February 12, 2018
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital of Wenzhou Medical University

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.

Condition or disease Intervention/treatment Phase
Anesthesia Hip Fracture Surgery Procedure: New "guideline" anesthesia strategy team Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Perioperative Anesthesia Care Bundle on Prognosis in Elderly Undergoing Hip Fracture Surgery: a Single-center Randomized Controlled Trial
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


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)



Primary Outcome Measures :
  1. Mortality [ Time Frame: 6 months after surgery ]
    Mortality in 6 months of postoperative


Secondary Outcome Measures :
  1. 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.

  2. Complications [ Time Frame: post-operation to discharge, an average of 2 weeks ]
    The incidence of postoperative complications

  3. Death rate [ Time Frame: Within 30 days and 1 year after surgery ]
    Mortality for postoperative of 30 days and 1 year

  4. Survival time [ Time Frame: up to one year after surgery ]
    Observed length of time after surgery to death within one year

  5. 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%

  6. Hospital stay [ Time Frame: Up to discharge,an average of 2 weeks ]
    Length of time stay in hospital

  7. Cost [ Time Frame: Length of hospital stay,an average of 2 weeks ]
    Total cost in hospital and expenditure for anesthesia

  8. MMSE [ Time Frame: Two days after surgery ]
    Cognitive function with Mini-Mental State Examination (MMSE)

  9. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03429010


Locations
China, Zhejiang
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 32500
Sponsors and Collaborators
Second Affiliated Hospital of Wenzhou Medical University
  Study Documents (Full-Text)

Documents provided by Second Affiliated Hospital of Wenzhou Medical University:
Study Protocol  [PDF] January 29, 2018


Responsible Party: Second Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT03429010     History of Changes
Other Study ID Numbers: SAHoWMU-CR2017-03-110
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Second Affiliated Hospital of Wenzhou Medical University:
Anesthesia
Hip Fracture

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs