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Status unknownNCT03429010EPAPHUSUpdated Sep 25, 2019

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

An interventional study of New "guideline" anesthesia strategy team in Anesthesia, Hip Fracture Surgery and Nursing, sponsored by Second Affiliated Hospital of Wenzhou Medical University. Status unknown at 1 site in China. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2019-09-25.

Sponsored by Second Affiliated Hospital of Wenzhou Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
75 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anesthesia
  • Hip Fracture Surgery
  • Nursing

Keywords

  • Anesthesia
  • Hip Fracture
03

Who can participate

Ages eligible
75 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    New "guideline"

    New "guideline" anesthesia strategy team (Group A)

    Procedure: New "guideline" anesthesia strategy team

  • No intervention
    Current strategy

    Current anesthesia strategy team (Group B)

Interventions

  • ProcedureNew "guideline" anesthesia strategy team

    New "guideline" anesthesia strategy team

05

What researchers measure

Primary outcomes

  1. Mortality

    Mortality in 6 months of postoperative

    Time frame: 6 months after surgery

Secondary outcomes

  1. 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.

    Time frame: within two days after surgery

  2. Complications

    The incidence of postoperative complications

    Time frame: post-operation to discharge, an average of 2 weeks

  3. Death rate

    Mortality for postoperative of 30 days and 1 year

    Time frame: Within 30 days and 1 year after surgery

  4. Survival time

    Observed length of time after surgery to death within one year

    Time frame: up to one year after surgery

  5. Compliance score

    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

  6. Hospital stay

    Length of time stay in hospital

    Time frame: Up to discharge,an average of 2 weeks

  7. Cost

    Total cost in hospital and expenditure for anesthesia

    Time frame: Length of hospital stay,an average of 2 weeks

  8. MMSE

    Cognitive function with Mini-Mental State Examination (MMSE)

    Time frame: Two days after surgery

  9. 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.

    Time frame: Two weeks before discharge

06

Study locations

1 of 1 sites recruiting
  • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
    Wenzhou, Zhejiang 32500, China
    Recruiting
07

References and documents

Study documents

  • Study protocol · Jan 29, 2018

Documents are hosted by the registry — open the source record to download them.

08

Registry details

Key details

Study ID
NCT03429010
Lead sponsor
Second Affiliated Hospital of Wenzhou Medical University
Responsible party
Sponsor
First posted
Feb 12, 2018
Start date
Jul 1, 2018
Primary completion
Nov 1, 2019 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Sep 25, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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