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

NCT ID: NCT03429010

Last Updated: 2019-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Anesthesia Hip Fracture Surgery Nursing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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New "guideline"

New "guideline" anesthesia strategy team (Group A)

Group Type EXPERIMENTAL

New "guideline" anesthesia strategy team

Intervention Type PROCEDURE

New "guideline" anesthesia strategy team

Current strategy

Current anesthesia strategy team (Group B)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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New "guideline" anesthesia strategy team

New "guideline" anesthesia strategy team

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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TING LI

Role: primary

13587876896

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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SAHoWMU-CR2017-03-110

Identifier Type: -

Identifier Source: org_study_id

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